{
"NDC": [
{
"NDCCode": "11716-9637-7",
"PackageDescription": "1 BOTTLE in 1 CARTON (11716-9637-7) > 15 mL in 1 BOTTLE",
"NDC11Code": "11716-9637-07",
"ProductNDC": "11716-9637",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Dry Eye Relief",
"NonProprietaryName": "Dextran 70",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20100712",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "HANLIM PHARM. CO., LTD.",
"SubstanceName": "DEXTRAN 70; HYPROMELLOSE 2910 (4000 CPS)",
"StrengthNumber": ".001; .003",
"StrengthUnit": "mL/mL; mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Directions: 1 Instill 1 or 2 drops in the affected eye(s) as needed., 2 Store at room temperature."
},
{
"NDCCode": "71335-9637-7",
"PackageDescription": "50 TABLET, FILM COATED in 1 BOTTLE (71335-9637-7) ",
"NDC11Code": "71335-9637-07",
"ProductNDC": "71335-9637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214548",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230206",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a, d] cycloheptene-Δ5 , γ-propylamine hydrochloride. It has the following structural formula. C20H23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included:. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "11716-0042-7",
"PackageDescription": "1 BOTTLE in 1 CARTON (11716-0042-7) > 15 mL in 1 BOTTLE",
"NDC11Code": "11716-0042-07",
"ProductNDC": "11716-0042",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Goodsense Lubricant Eye Drops",
"NonProprietaryName": "Polyethylene Glycol 400",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20100804",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "HANLIM PHARM. CO., LTD.",
"SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
"StrengthNumber": ".4; .3",
"StrengthUnit": "mL/mL; mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Directions: 1 Put 1 or 2 drops in the affected eye/s as needed."
},
{
"NDCCode": "11716-0051-7",
"PackageDescription": "1 BOTTLE in 1 CARTON (11716-0051-7) > 15 mL in 1 BOTTLE",
"NDC11Code": "11716-0051-07",
"ProductNDC": "11716-0051",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dg Lubricant Eye Drops",
"NonProprietaryName": "Polyethylene Glycol 400",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20100426",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "HANLIM PHARM. CO., LTD.",
"SubstanceName": "POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL",
"StrengthNumber": ".4; .3",
"StrengthUnit": "mL/mL; mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Directions: 1 Instill 1 to 2 drops in the affected eye(s) as needed, 2 Children under 6 years of age: Ask a doctor."
},
{
"NDCCode": "11716-1163-7",
"PackageDescription": "1 BOTTLE in 1 CARTON (11716-1163-7) > 5 mL in 1 BOTTLE",
"NDC11Code": "11716-1163-07",
"ProductNDC": "11716-1163",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Eye Itch Relief Drops",
"NonProprietaryName": "Ketotifen Fumarate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20100421",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "HANLIM PHARM. CO., LTD.",
"SubstanceName": "KETOTIFEN FUMARATE",
"StrengthNumber": ".345",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Directions: 1 Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day, 2 Children under 3 years of age: Consult a doctor."
},
{
"NDCCode": "11716-1167-7",
"PackageDescription": "1 BOTTLE in 1 CARTON (11716-1167-7) > 15 mL in 1 BOTTLE",
"NDC11Code": "11716-1167-07",
"ProductNDC": "11716-1167",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Walgreens Maximum Relief Eye Drops",
"NonProprietaryName": "Dextran 70",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20100526",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "HANLIM PHARM. CO., LTD.",
"SubstanceName": "DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE",
"StrengthNumber": ".001; .01; .01; .0005",
"StrengthUnit": "mL/mL; mL/mL; mL/mL; mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Directions: 1 put 1 to 2 drops in the affected eye(s) up to 4 times daily, 2 children under 6 years of age: ask a doctor."
},
{
"NDCCode": "0143-9637-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 TRAY (0143-9637-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9637-01) ",
"NDC11Code": "00143-9637-10",
"ProductNDC": "0143-9637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valproate Sodium",
"NonProprietaryName": "Valproate Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078523",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "VALPROATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130415",
"SamplePackage": "N",
"IndicationAndUsage": "Valproate Sodium Injection is indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions: : 1 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1) .",
"Description": "Valproate sodium is the sodium salt of valproic acid designated as sodium 2-propylpentanoate. Valproate sodium has the following structure:. Valproate sodium has a molecular weight of 166.2. It occurs as an essentially white and odorless, crystalline, deliquescent powder. Valproate Sodium Injection, USP is available in 5 mL single dose vials for intravenous injection. Each mL contains valproate sodium equivalent to 100 mg valproic acid, edetate disodium 0.40 mg, and water for injection to volume. The pH is adjusted to 7.6 with sodium hydroxide and/or hydrochloric acid. The solution is clear and colorless."
},
{
"NDCCode": "0338-9637-01",
"PackageDescription": "2 mL in 1 SYRINGE, PLASTIC (0338-9637-01) ",
"NDC11Code": "00338-9637-01",
"ProductNDC": "0338-9637",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Artiss",
"ProprietaryNameSuffix": "Fibrin Sealant",
"NonProprietaryName": "Fibrinogen Human, Human Thrombin",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080319",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125266",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
"StrengthNumber": "86.5; 4",
"StrengthUnit": "mg/mL; [iU]/mL",
"Pharm_Classes": "Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080319",
"SamplePackage": "N",
"IndicationAndUsage": "ARTISS is a fibrin sealant indicated in adult and pediatric patients to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns., 2 Adhere tissue flaps during facial rhytidectomy surgery.",
"Description": "ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor, Aprotinin (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at U.S. licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV-1, BVDV, PRV, HAV and MMV (Human Parvovirus B19). The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 5 for each of the viruses tested. Table 5: Mean Reduction Factors [log10] for Virus Removal and/or Inactivation. Sealer Protein Component. Thrombin Component. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and >4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively."
},
{
"NDCCode": "0406-0512-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0406-0512-01) ",
"NDC11Code": "00406-0512-01",
"ProductNDC": "0406-0512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19831207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19831207",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0512-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0406-0512-05) ",
"NDC11Code": "00406-0512-05",
"ProductNDC": "0406-0512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19831207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19831207",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0512-23",
"PackageDescription": "1 TABLET in 1 BLISTER PACK (0406-0512-23) ",
"NDC11Code": "00406-0512-23",
"ProductNDC": "0406-0512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19831207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19831207",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0512-62",
"PackageDescription": "100 TABLET in 1 BLISTER PACK (0406-0512-62) ",
"NDC11Code": "00406-0512-62",
"ProductNDC": "0406-0512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19831207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19831207",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0512-91",
"PackageDescription": "5000 TABLET in 1 PAIL (0406-0512-91) ",
"NDC11Code": "00406-0512-91",
"ProductNDC": "0406-0512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19831207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087463",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19831207",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0522-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0406-0522-01) ",
"NDC11Code": "00406-0522-01",
"ProductNDC": "0406-0522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040545",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040630",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0522-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0406-0522-05) ",
"NDC11Code": "00406-0522-05",
"ProductNDC": "0406-0522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040545",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040630",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0522-23",
"PackageDescription": "1 TABLET in 1 BLISTER PACK (0406-0522-23) ",
"NDC11Code": "00406-0522-23",
"ProductNDC": "0406-0522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040545",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040630",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0522-62",
"PackageDescription": "100 TABLET in 1 BLISTER PACK (0406-0522-62) ",
"NDC11Code": "00406-0522-62",
"ProductNDC": "0406-0522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040545",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040630",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0523-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0406-0523-01) ",
"NDC11Code": "00406-0523-01",
"ProductNDC": "0406-0523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040545",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040630",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0523-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (0406-0523-05) ",
"NDC11Code": "00406-0523-05",
"ProductNDC": "0406-0523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040545",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040630",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0523-23",
"PackageDescription": "1 TABLET in 1 BLISTER PACK (0406-0523-23) ",
"NDC11Code": "00406-0523-23",
"ProductNDC": "0406-0523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040545",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040630",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0406-0523-62",
"PackageDescription": "100 TABLET in 1 BLISTER PACK (0406-0523-62) ",
"NDC11Code": "00406-0523-62",
"ProductNDC": "0406-0523",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone Hydrochloride And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040545",
"LabelerName": "SpecGx LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040630",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula."
},
{
"NDCCode": "0904-7093-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7093-61) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-7093-61",
"ProductNDC": "0904-7093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207510",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190601",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen Tablets, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen Tablets, USP is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone hydrochloride USP 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP................................................. 325 mg. Oxycodone hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone) Acetaminophen USP.............................................……....... 325 mg. Oxycodone hydrochloride, USP 10 mg* (*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone) Acetaminophen USP...................................................…..... 325 mg. Inactive Ingredients. The tablets contain: Colloidal silicon dioxide, pregelatinized starch, crospovidone, croscarmellose sodium, microcrystalline cellulose, stearic acid and magnesium stearate. In addition, the 5 mg/325 mg strength contains FD&C Blue # 1 Aluminum Lake and the 7.5 mg/325 mg strength contains FD&C Red # 40 Aluminum Lake. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "0904-7094-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7094-61) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-7094-61",
"ProductNDC": "0904-7094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207510",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190601",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen Tablets, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen Tablets, USP is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone hydrochloride USP 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP................................................. 325 mg. Oxycodone hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone) Acetaminophen USP.............................................……....... 325 mg. Oxycodone hydrochloride, USP 10 mg* (*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone) Acetaminophen USP...................................................…..... 325 mg. Inactive Ingredients. The tablets contain: Colloidal silicon dioxide, pregelatinized starch, crospovidone, croscarmellose sodium, microcrystalline cellulose, stearic acid and magnesium stearate. In addition, the 5 mg/325 mg strength contains FD&C Blue # 1 Aluminum Lake and the 7.5 mg/325 mg strength contains FD&C Red # 40 Aluminum Lake. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "0904-7095-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7095-61) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00904-7095-61",
"ProductNDC": "0904-7095",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207510",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "10; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190601",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone and Acetaminophen Tablets, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and Acetaminophen Tablets, USP is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone hydrochloride USP 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP................................................. 325 mg. Oxycodone hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone) Acetaminophen USP.............................................……....... 325 mg. Oxycodone hydrochloride, USP 10 mg* (*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone) Acetaminophen USP...................................................…..... 325 mg. Inactive Ingredients. The tablets contain: Colloidal silicon dioxide, pregelatinized starch, crospovidone, croscarmellose sodium, microcrystalline cellulose, stearic acid and magnesium stearate. In addition, the 5 mg/325 mg strength contains FD&C Blue # 1 Aluminum Lake and the 7.5 mg/325 mg strength contains FD&C Red # 40 Aluminum Lake. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula."
},
{
"NDCCode": "10702-184-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10702-184-01) ",
"NDC11Code": "10702-0184-01",
"ProductNDC": "10702-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210644",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "OXYCODONE; ACETAMINOPHEN",
"StrengthNumber": "2.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180209",
"SamplePackage": "N",
"IndicationAndUsage": "Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:."
},
{
"NDCCode": "10702-184-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (10702-184-10) ",
"NDC11Code": "10702-0184-10",
"ProductNDC": "10702-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210644",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "OXYCODONE; ACETAMINOPHEN",
"StrengthNumber": "2.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180209",
"SamplePackage": "N",
"IndicationAndUsage": "Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:."
},
{
"NDCCode": "10702-184-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (10702-184-50) ",
"NDC11Code": "10702-0184-50",
"ProductNDC": "10702-184",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210644",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "OXYCODONE; ACETAMINOPHEN",
"StrengthNumber": "2.5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180209",
"SamplePackage": "N",
"IndicationAndUsage": "Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:."
},
{
"NDCCode": "10702-185-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10702-185-01) ",
"NDC11Code": "10702-0185-01",
"ProductNDC": "10702-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210644",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "OXYCODONE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180209",
"SamplePackage": "N",
"IndicationAndUsage": "Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:."
},
{
"NDCCode": "10702-185-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (10702-185-10) ",
"NDC11Code": "10702-0185-10",
"ProductNDC": "10702-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210644",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "OXYCODONE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180209",
"SamplePackage": "N",
"IndicationAndUsage": "Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:."
},
{
"NDCCode": "10702-185-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (10702-185-50) ",
"NDC11Code": "10702-0185-50",
"ProductNDC": "10702-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210644",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "OXYCODONE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180209",
"SamplePackage": "N",
"IndicationAndUsage": "Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:."
}
]
}
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<NDC>
<NDCCode>11716-9637-7</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11716-9637-7) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11716-9637-07</NDC11Code>
<ProductNDC>11716-9637</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Dry Eye Relief</ProprietaryName>
<NonProprietaryName>Dextran 70</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20100712</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>HANLIM PHARM. CO., LTD.</LabelerName>
<SubstanceName>DEXTRAN 70; HYPROMELLOSE 2910 (4000 CPS)</SubstanceName>
<StrengthNumber>.001; .003</StrengthNumber>
<StrengthUnit>mL/mL; mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 Instill 1 or 2 drops in the affected eye(s) as needed., 2 Store at room temperature.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-9637-7</NDCCode>
<PackageDescription>50 TABLET, FILM COATED in 1 BOTTLE (71335-9637-7) </PackageDescription>
<NDC11Code>71335-9637-07</NDC11Code>
<ProductNDC>71335-9637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210526</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214548</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a, d] cycloheptene-Δ5 , γ-propylamine hydrochloride. It has the following structural formula. C20H23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included:. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>11716-0042-7</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11716-0042-7) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11716-0042-07</NDC11Code>
<ProductNDC>11716-0042</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Goodsense Lubricant Eye Drops</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 400</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20100804</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>HANLIM PHARM. CO., LTD.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>.4; .3</StrengthNumber>
<StrengthUnit>mL/mL; mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 Put 1 or 2 drops in the affected eye/s as needed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11716-0051-7</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11716-0051-7) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11716-0051-07</NDC11Code>
<ProductNDC>11716-0051</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dg Lubricant Eye Drops</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 400</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20100426</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>HANLIM PHARM. CO., LTD.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>.4; .3</StrengthNumber>
<StrengthUnit>mL/mL; mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 Instill 1 to 2 drops in the affected eye(s) as needed, 2 Children under 6 years of age: Ask a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11716-1163-7</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11716-1163-7) > 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11716-1163-07</NDC11Code>
<ProductNDC>11716-1163</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Eye Itch Relief Drops</ProprietaryName>
<NonProprietaryName>Ketotifen Fumarate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20100421</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>HANLIM PHARM. CO., LTD.</LabelerName>
<SubstanceName>KETOTIFEN FUMARATE</SubstanceName>
<StrengthNumber>.345</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day, 2 Children under 3 years of age: Consult a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11716-1167-7</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11716-1167-7) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11716-1167-07</NDC11Code>
<ProductNDC>11716-1167</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Walgreens Maximum Relief Eye Drops</ProprietaryName>
<NonProprietaryName>Dextran 70</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20100526</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>HANLIM PHARM. CO., LTD.</LabelerName>
<SubstanceName>DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.001; .01; .01; .0005</StrengthNumber>
<StrengthUnit>mL/mL; mL/mL; mL/mL; mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 put 1 to 2 drops in the affected eye(s) up to 4 times daily, 2 children under 6 years of age: ask a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0143-9637-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 TRAY (0143-9637-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9637-01) </PackageDescription>
<NDC11Code>00143-9637-10</NDC11Code>
<ProductNDC>0143-9637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valproate Sodium</ProprietaryName>
<NonProprietaryName>Valproate Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078523</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VALPROATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valproate Sodium Injection is indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions: : 1 Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1) .</IndicationAndUsage>
<Description>Valproate sodium is the sodium salt of valproic acid designated as sodium 2-propylpentanoate. Valproate sodium has the following structure:. Valproate sodium has a molecular weight of 166.2. It occurs as an essentially white and odorless, crystalline, deliquescent powder. Valproate Sodium Injection, USP is available in 5 mL single dose vials for intravenous injection. Each mL contains valproate sodium equivalent to 100 mg valproic acid, edetate disodium 0.40 mg, and water for injection to volume. The pH is adjusted to 7.6 with sodium hydroxide and/or hydrochloric acid. The solution is clear and colorless.</Description>
</NDC>
<NDC>
<NDCCode>0338-9637-01</NDCCode>
<PackageDescription>2 mL in 1 SYRINGE, PLASTIC (0338-9637-01) </PackageDescription>
<NDC11Code>00338-9637-01</NDC11Code>
<ProductNDC>0338-9637</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Artiss</ProprietaryName>
<ProprietaryNameSuffix>Fibrin Sealant</ProprietaryNameSuffix>
<NonProprietaryName>Fibrinogen Human, Human Thrombin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080319</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125266</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>FIBRINOGEN HUMAN; HUMAN THROMBIN</SubstanceName>
<StrengthNumber>86.5; 4</StrengthNumber>
<StrengthUnit>mg/mL; [iU]/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ARTISS is a fibrin sealant indicated in adult and pediatric patients to: 1 Adhere autologous skin grafts to surgically prepared wound beds resulting from burns., 2 Adhere tissue flaps during facial rhytidectomy surgery.</IndicationAndUsage>
<Description>ARTISS [Fibrin Sealant (Human)] is a two-component fibrin sealant made from pooled human plasma. Sealer Protein SolutionTotal protein: 96 -125 mg/mLFibrinogen: 67 - 106 mg/mLFibrinolysis Inhibitor, Aprotinin (Synthetic): 2250 - 3750 Kallidinogenase Inhibiting Unit/mL. Other ingredients include: Human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection (WFI). Thrombin SolutionThrombin (Human): 2.5 - 6.5 units/mL1Calcium Chloride: 36 - 44 µmol/mLOther ingredients include: Human albumin, sodium chloride and water for injection (WFI). 1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit is equivalent to an International Unit (IU). Sealer Protein (Human). Sealer Protein (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (1). The active ingredient in Sealer Protein (Human) is fibrinogen. A Fibrinolysis Inhibitor, Aprotinin (Synthetic) is included in the Sealer Protein (Human) component to delay fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin. Thrombin (Human). Thrombin (Human) is a sterile, non-pyrogenic, vapor-heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is provided as a frozen liquid solution pre-filled into one side of a dual-chambered syringe (2). Sealer Protein (Human) and Thrombin (Human) are made from pooled human plasma collected at U.S. licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma [see Viral Clearance below and Warnings and Precautions (5.4)]. Viral Clearance. The manufacturing procedure includes processing steps designed to further reduce the risk of viral transmission. In particular, vapor heating and solvent/detergent treatment processes are included in the manufacturing of Sealer Protein and Thrombin. Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The stock virus suspensions represent HIV-1, BVDV, PRV, HAV and MMV (Human Parvovirus B19). The virus reduction factors (expressed as log10) of independent manufacturing steps are shown in Table 5 for each of the viruses tested. Table 5: Mean Reduction Factors [log10] for Virus Removal and/or Inactivation. Sealer Protein Component. Thrombin Component. In addition, Human Parvovirus B19 was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated log reduction factors obtained were 1.7 and 3.4 for the Thrombin precursor mass capture step and Sealer Protein early manufacturing steps and >4 / 1.0 for the Thrombin / Sealer Protein vapor heating steps, respectively.</Description>
</NDC>
<NDC>
<NDCCode>0406-0512-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0406-0512-01) </PackageDescription>
<NDC11Code>00406-0512-01</NDC11Code>
<ProductNDC>0406-0512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19831207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19831207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0406-0512-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0406-0512-05) </PackageDescription>
<NDC11Code>00406-0512-05</NDC11Code>
<ProductNDC>0406-0512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19831207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19831207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0406-0512-23</NDCCode>
<PackageDescription>1 TABLET in 1 BLISTER PACK (0406-0512-23) </PackageDescription>
<NDC11Code>00406-0512-23</NDC11Code>
<ProductNDC>0406-0512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19831207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19831207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0406-0512-62</NDCCode>
<PackageDescription>100 TABLET in 1 BLISTER PACK (0406-0512-62) </PackageDescription>
<NDC11Code>00406-0512-62</NDC11Code>
<ProductNDC>0406-0512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19831207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19831207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0406-0512-91</NDCCode>
<PackageDescription>5000 TABLET in 1 PAIL (0406-0512-91) </PackageDescription>
<NDC11Code>00406-0512-91</NDC11Code>
<ProductNDC>0406-0512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19831207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087463</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19831207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0406-0522-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0406-0522-01) </PackageDescription>
<NDC11Code>00406-0522-01</NDC11Code>
<ProductNDC>0406-0522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040545</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0406-0522-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0406-0522-05) </PackageDescription>
<NDC11Code>00406-0522-05</NDC11Code>
<ProductNDC>0406-0522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040545</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0406-0522-23</NDCCode>
<PackageDescription>1 TABLET in 1 BLISTER PACK (0406-0522-23) </PackageDescription>
<NDC11Code>00406-0522-23</NDC11Code>
<ProductNDC>0406-0522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040545</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0406-0522-62</NDCCode>
<PackageDescription>100 TABLET in 1 BLISTER PACK (0406-0522-62) </PackageDescription>
<NDC11Code>00406-0522-62</NDC11Code>
<ProductNDC>0406-0522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040545</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0406-0523-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0406-0523-01) </PackageDescription>
<NDC11Code>00406-0523-01</NDC11Code>
<ProductNDC>0406-0523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040545</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0406-0523-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0406-0523-05) </PackageDescription>
<NDC11Code>00406-0523-05</NDC11Code>
<ProductNDC>0406-0523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040545</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
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<NDC>
<NDCCode>0406-0523-23</NDCCode>
<PackageDescription>1 TABLET in 1 BLISTER PACK (0406-0523-23) </PackageDescription>
<NDC11Code>00406-0523-23</NDC11Code>
<ProductNDC>0406-0523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040545</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
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<LastUpdate>2026-07-28</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0406-0523-62</NDCCode>
<PackageDescription>100 TABLET in 1 BLISTER PACK (0406-0523-62) </PackageDescription>
<NDC11Code>00406-0523-62</NDC11Code>
<ProductNDC>0406-0523</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040545</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
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<LastUpdate>2026-07-28</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy (see WARNINGS), reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone Hydrochloride USP................................................................. 5 mg*(*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP............................................................. 7.5 mg*(*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Oxycodone Hydrochloride USP.............................................................. 10 mg*(*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone)Acetaminophen USP.............................................................................. 325 mg. Inactive Ingredients. The tablets contain: crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0904-7093-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7093-61) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7093-61</NDC11Code>
<ProductNDC>0904-7093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207510</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen Tablets, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen Tablets, USP is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone hydrochloride USP 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP................................................. 325 mg. Oxycodone hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone) Acetaminophen USP.............................................……....... 325 mg. Oxycodone hydrochloride, USP 10 mg* (*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone) Acetaminophen USP...................................................…..... 325 mg. Inactive Ingredients. The tablets contain: Colloidal silicon dioxide, pregelatinized starch, crospovidone, croscarmellose sodium, microcrystalline cellulose, stearic acid and magnesium stearate. In addition, the 5 mg/325 mg strength contains FD&C Blue # 1 Aluminum Lake and the 7.5 mg/325 mg strength contains FD&C Red # 40 Aluminum Lake. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0904-7094-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7094-61) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7094-61</NDC11Code>
<ProductNDC>0904-7094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207510</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen Tablets, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen Tablets, USP is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone hydrochloride USP 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP................................................. 325 mg. Oxycodone hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone) Acetaminophen USP.............................................……....... 325 mg. Oxycodone hydrochloride, USP 10 mg* (*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone) Acetaminophen USP...................................................…..... 325 mg. Inactive Ingredients. The tablets contain: Colloidal silicon dioxide, pregelatinized starch, crospovidone, croscarmellose sodium, microcrystalline cellulose, stearic acid and magnesium stearate. In addition, the 5 mg/325 mg strength contains FD&C Blue # 1 Aluminum Lake and the 7.5 mg/325 mg strength contains FD&C Red # 40 Aluminum Lake. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0904-7095-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7095-61) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7095-61</NDC11Code>
<ProductNDC>0904-7095</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207510</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>10; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone and Acetaminophen Tablets, is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and Acetaminophen Tablets, USP is available in tablets for oral administration. Each tablet for oral administration contains. Oxycodone hydrochloride USP 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP................................................. 325 mg. Oxycodone hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone) Acetaminophen USP.............................................……....... 325 mg. Oxycodone hydrochloride, USP 10 mg* (*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone) Acetaminophen USP...................................................…..... 325 mg. Inactive Ingredients. The tablets contain: Colloidal silicon dioxide, pregelatinized starch, crospovidone, croscarmellose sodium, microcrystalline cellulose, stearic acid and magnesium stearate. In addition, the 5 mg/325 mg strength contains FD&C Blue # 1 Aluminum Lake and the 7.5 mg/325 mg strength contains FD&C Red # 40 Aluminum Lake. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C18H21NO4 HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula. Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4’-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>10702-184-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10702-184-01) </PackageDescription>
<NDC11Code>10702-0184-01</NDC11Code>
<ProductNDC>10702-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210644</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>OXYCODONE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>2.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>10702-184-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (10702-184-10) </PackageDescription>
<NDC11Code>10702-0184-10</NDC11Code>
<ProductNDC>10702-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210644</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>OXYCODONE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>2.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>10702-184-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (10702-184-50) </PackageDescription>
<NDC11Code>10702-0184-50</NDC11Code>
<ProductNDC>10702-184</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210644</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>OXYCODONE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>2.5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>10702-185-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10702-185-01) </PackageDescription>
<NDC11Code>10702-0185-01</NDC11Code>
<ProductNDC>10702-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210644</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>OXYCODONE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>10702-185-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (10702-185-10) </PackageDescription>
<NDC11Code>10702-0185-10</NDC11Code>
<ProductNDC>10702-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210644</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>OXYCODONE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>10702-185-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (10702-185-50) </PackageDescription>
<NDC11Code>10702-0185-50</NDC11Code>
<ProductNDC>10702-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210644</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>OXYCODONE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings] , reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone and acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths. Oxycodone hydrochloride, USP 2.5 mg*. (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 5 mg*. (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 7.5 mg*. (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.). Acetaminophen, USP 325 mg. Oxycodone hydrochloride, USP 10 mg*. (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.). Acetaminophen, USP 325 mg. All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pre-gelatized corn starch and stearic acid. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18H 21NO 4·HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:. Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8H 9NO 2and the molecular weight is 151.16. It may be represented by the following structural formula:.</Description>
</NDC>
</NDCList>