{
"NDC": [
{
"NDCCode": "0406-8025-28",
"PackageDescription": "90 kg in 1 DRUM (0406-8025-28)",
"NDC11Code": "00406-8025-28",
"ProductNDC": "0406-8025",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Sulfate Anhydrous",
"DosageFormName": "POWDER",
"StartMarketingDate": "20020606",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Mallinckrodt, Inc.",
"SubstanceName": "SODIUM SULFATE ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0406-8025-00",
"PackageDescription": "100 kg in 1 DRUM (0406-8025-00)",
"NDC11Code": "00406-8025-00",
"ProductNDC": "0406-8025",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Sulfate Anhydrous",
"DosageFormName": "POWDER",
"StartMarketingDate": "20020606",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Mallinckrodt, Inc.",
"SubstanceName": "SODIUM SULFATE ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0406-8025-30",
"PackageDescription": "90 kg in 1 DRUM (0406-8025-30)",
"NDC11Code": "00406-8025-30",
"ProductNDC": "0406-8025",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Sulfate Anhydrous",
"DosageFormName": "POWDER",
"StartMarketingDate": "20020606",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Mallinckrodt, Inc.",
"SubstanceName": "SODIUM SULFATE ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0406-8025-40",
"PackageDescription": "90 kg in 1 DRUM (0406-8025-40)",
"NDC11Code": "00406-8025-40",
"ProductNDC": "0406-8025",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Sulfate Anhydrous",
"DosageFormName": "POWDER",
"StartMarketingDate": "20020606",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Mallinckrodt, Inc.",
"SubstanceName": "SODIUM SULFATE ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0406-7096-28",
"PackageDescription": "90 kg in 1 DRUM (0406-7096-28)",
"NDC11Code": "00406-7096-28",
"ProductNDC": "0406-7096",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Potassium Phosphate Monobasic",
"DosageFormName": "POWDER",
"StartMarketingDate": "20020605",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Mallinckrodt, Inc.",
"SubstanceName": "POTASSIUM PHOSPHATE, MONOBASIC",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0406-8028-28",
"PackageDescription": "90 kg in 1 DRUM (0406-8028-28)",
"NDC11Code": "00406-8028-28",
"ProductNDC": "0406-8028",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Sulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "19730630",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Mallinckrodt, Inc.",
"SubstanceName": "SODIUM SULFATE ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "37808-406-28",
"PackageDescription": "200 TABLET, CHEWABLE in 1 BOTTLE (37808-406-28) ",
"NDC11Code": "37808-0406-28",
"ProductNDC": "37808-406",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heb Antacid Extra Strength",
"ProprietaryNameSuffix": "Assorted Berry",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190305",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "HEB",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190305",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "58232-0406-1",
"PackageDescription": "1 TUBE in 1 CARTON (58232-0406-1) > 28 g in 1 TUBE",
"NDC11Code": "58232-0406-01",
"ProductNDC": "58232-0406",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cortaid",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Hydrocortisone Acetate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091030",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson consumer Companies, Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2015-01-23"
},
{
"NDCCode": "71335-0406-8",
"PackageDescription": "28 TABLET in 1 BOTTLE (71335-0406-8) ",
"NDC11Code": "71335-0406-08",
"ProductNDC": "71335-0406",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077927",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190724",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).",
"Description": "Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
},
{
"NDCCode": "72036-406-28",
"PackageDescription": "1 TUBE in 1 CARTON (72036-406-28) > 28 g in 1 TUBE",
"NDC11Code": "72036-0406-28",
"ProductNDC": "72036-406",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Harris Teeter Maximum Strength Anti-itch",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170417",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Harris Teeter",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Directions: 1 for itching of skin irritation, , 2 adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, 3 children under 2 years of age: ask a doctor, 4 for external anal and genital itching, adults:, 5 when practical, clean the affected area with mild soap and warm water and rinse thoroughly, 6 gently dry by patting or blotting with toilet tissue or soft cloth before applying, 7 apply to affected area not more 3 to 4 times daily, 8 chldren under 12 years of age: ask a doctor."
},
{
"NDCCode": "0406-0117-24",
"PackageDescription": "50 kg in 1 DRUM (0406-0117-24) ",
"NDC11Code": "00406-0117-24",
"ProductNDC": "0406-0117",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen Anhydrous Basis And Chlorpheniramine Maleate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130211",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SpecGx LLC",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE",
"StrengthNumber": ".9; .0055",
"StrengthUnit": "kg/kg; kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-12-28",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "11-FEB-13"
},
{
"NDCCode": "0406-0117-44",
"PackageDescription": "50 kg in 1 DRUM (0406-0117-44) ",
"NDC11Code": "00406-0117-44",
"ProductNDC": "0406-0117",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen Anhydrous Basis And Chlorpheniramine Maleate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130211",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SpecGx LLC",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE",
"StrengthNumber": ".9; .0055",
"StrengthUnit": "kg/kg; kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-12-28",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "11-FEB-13"
},
{
"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": "0406-1810-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-1810-01) ",
"NDC11Code": "00406-1810-01",
"ProductNDC": "0406-1810",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203583",
"LabelerName": "SpecGx LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150929",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate HCl extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate HCl extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].",
"Description": "Methylphenidate HCl extended-release capsules contain methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate HCl extended-release capsules are available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release capsules also contain the following inactive ingredients: Sugar Spheres, Ethylcellulose, Oleic Acid, Medium-Chain Triglycerides, Titanium Dioxide, Gelatin, Shellac, Propylene Glycol, Hypromellose, Polyethylene Glycol, and Black Iron Oxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, Yellow Iron Oxide, Sodium Hydroxide, Povidone. 20 mg capsules: FD&C Blue No. 2, Sodium Hydroxide, Povidone. 30 mg capsules: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, Sodium Hydroxide, Povidone. 40 mg capsules: Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, Red Iron Oxide, Sodium Hydroxide, Povidone."
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"Description": "Methylphenidate HCl extended-release capsules contain methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate HCl extended-release capsules are available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release capsules also contain the following inactive ingredients: Sugar Spheres, Ethylcellulose, Oleic Acid, Medium-Chain Triglycerides, Titanium Dioxide, Gelatin, Shellac, Propylene Glycol, Hypromellose, Polyethylene Glycol, and Black Iron Oxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, Yellow Iron Oxide, Sodium Hydroxide, Povidone. 20 mg capsules: FD&C Blue No. 2, Sodium Hydroxide, Povidone. 30 mg capsules: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, Sodium Hydroxide, Povidone. 40 mg capsules: Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, Red Iron Oxide, Sodium Hydroxide, Povidone."
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"Description": "Methylphenidate HCl extended-release capsules contain methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate HCl extended-release capsules are available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release capsules also contain the following inactive ingredients: Sugar Spheres, Ethylcellulose, Oleic Acid, Medium-Chain Triglycerides, Titanium Dioxide, Gelatin, Shellac, Propylene Glycol, Hypromellose, Polyethylene Glycol, and Black Iron Oxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, Yellow Iron Oxide, Sodium Hydroxide, Povidone. 20 mg capsules: FD&C Blue No. 2, Sodium Hydroxide, Povidone. 30 mg capsules: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, Sodium Hydroxide, Povidone. 40 mg capsules: Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, Red Iron Oxide, Sodium Hydroxide, Povidone."
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"Description": "Methylphenidate HCl extended-release capsules contain methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate HCl extended-release capsules are available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release capsules also contain the following inactive ingredients: Sugar Spheres, Ethylcellulose, Oleic Acid, Medium-Chain Triglycerides, Titanium Dioxide, Gelatin, Shellac, Propylene Glycol, Hypromellose, Polyethylene Glycol, and Black Iron Oxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, Yellow Iron Oxide, Sodium Hydroxide, Povidone. 20 mg capsules: FD&C Blue No. 2, Sodium Hydroxide, Povidone. 30 mg capsules: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, Sodium Hydroxide, Povidone. 40 mg capsules: Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, Red Iron Oxide, Sodium Hydroxide, Povidone."
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"Description": "Methylphenidate HCl extended-release capsules contain methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate HCl extended-release capsules are available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release capsules also contain the following inactive ingredients: Sugar Spheres, Ethylcellulose, Oleic Acid, Medium-Chain Triglycerides, Titanium Dioxide, Gelatin, Shellac, Propylene Glycol, Hypromellose, Polyethylene Glycol, and Black Iron Oxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, Yellow Iron Oxide, Sodium Hydroxide, Povidone. 20 mg capsules: FD&C Blue No. 2, Sodium Hydroxide, Povidone. 30 mg capsules: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, Sodium Hydroxide, Povidone. 40 mg capsules: Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, Red Iron Oxide, Sodium Hydroxide, Povidone."
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).</IndicationAndUsage>
<Description>Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>72036-406-28</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72036-406-28) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>72036-0406-28</NDC11Code>
<ProductNDC>72036-406</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Harris Teeter Maximum Strength Anti-itch</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170417</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Harris Teeter</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 for itching of skin irritation, , 2 adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, 3 children under 2 years of age: ask a doctor, 4 for external anal and genital itching, adults:, 5 when practical, clean the affected area with mild soap and warm water and rinse thoroughly, 6 gently dry by patting or blotting with toilet tissue or soft cloth before applying, 7 apply to affected area not more 3 to 4 times daily, 8 chldren under 12 years of age: ask a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0406-0117-24</NDCCode>
<PackageDescription>50 kg in 1 DRUM (0406-0117-24) </PackageDescription>
<NDC11Code>00406-0117-24</NDC11Code>
<ProductNDC>0406-0117</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Acetaminophen Anhydrous Basis And Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130211</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>.9; .0055</StrengthNumber>
<StrengthUnit>kg/kg; kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-28</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-FEB-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0406-0117-44</NDCCode>
<PackageDescription>50 kg in 1 DRUM (0406-0117-44) </PackageDescription>
<NDC11Code>00406-0117-44</NDC11Code>
<ProductNDC>0406-0117</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Acetaminophen Anhydrous Basis And Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130211</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>.9; .0055</StrengthNumber>
<StrengthUnit>kg/kg; kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-28</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-FEB-13</StartMarketingDatePackage>
</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>
<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>0406-0512-62</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>
<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>0406-0512-91</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>
</NDC>
<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>
<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>0406-0523-62</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>
<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>0406-1810-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-1810-01) </PackageDescription>
<NDC11Code>00406-1810-01</NDC11Code>
<ProductNDC>0406-1810</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203583</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylphenidate HCl extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate HCl extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate HCl extended-release capsules contain methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate HCl extended-release capsules are available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release capsules also contain the following inactive ingredients: Sugar Spheres, Ethylcellulose, Oleic Acid, Medium-Chain Triglycerides, Titanium Dioxide, Gelatin, Shellac, Propylene Glycol, Hypromellose, Polyethylene Glycol, and Black Iron Oxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, Yellow Iron Oxide, Sodium Hydroxide, Povidone. 20 mg capsules: FD&C Blue No. 2, Sodium Hydroxide, Povidone. 30 mg capsules: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, Sodium Hydroxide, Povidone. 40 mg capsules: Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, Red Iron Oxide, Sodium Hydroxide, Povidone.</Description>
</NDC>
<NDC>
<NDCCode>0406-1820-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-1820-01) </PackageDescription>
<NDC11Code>00406-1820-01</NDC11Code>
<ProductNDC>0406-1820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203583</ApplicationNumber>
<LabelerName>SpecGx LLC</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150929</StartMarketingDatePackage>
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<IndicationAndUsage>Methylphenidate HCl extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate HCl extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7), Use in Specific Populations (8.4)].</IndicationAndUsage>
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<Description>Methylphenidate HCl extended-release capsules contain methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate HCl extended-release capsules are available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release capsules also contain the following inactive ingredients: Sugar Spheres, Ethylcellulose, Oleic Acid, Medium-Chain Triglycerides, Titanium Dioxide, Gelatin, Shellac, Propylene Glycol, Hypromellose, Polyethylene Glycol, and Black Iron Oxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, Yellow Iron Oxide, Sodium Hydroxide, Povidone. 20 mg capsules: FD&C Blue No. 2, Sodium Hydroxide, Povidone. 30 mg capsules: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, Sodium Hydroxide, Povidone. 40 mg capsules: Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, Red Iron Oxide, Sodium Hydroxide, Povidone.</Description>
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<Description>Methylphenidate HCl extended-release capsules contain methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate HCl extended-release capsules are available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release capsules also contain the following inactive ingredients: Sugar Spheres, Ethylcellulose, Oleic Acid, Medium-Chain Triglycerides, Titanium Dioxide, Gelatin, Shellac, Propylene Glycol, Hypromellose, Polyethylene Glycol, and Black Iron Oxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, Yellow Iron Oxide, Sodium Hydroxide, Povidone. 20 mg capsules: FD&C Blue No. 2, Sodium Hydroxide, Povidone. 30 mg capsules: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, Sodium Hydroxide, Povidone. 40 mg capsules: Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, Red Iron Oxide, Sodium Hydroxide, Povidone.</Description>
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<Description>Methylphenidate HCl extended-release capsules contain methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate HCl extended-release capsules are available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl extended-release capsules also contain the following inactive ingredients: Sugar Spheres, Ethylcellulose, Oleic Acid, Medium-Chain Triglycerides, Titanium Dioxide, Gelatin, Shellac, Propylene Glycol, Hypromellose, Polyethylene Glycol, and Black Iron Oxide. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, Yellow Iron Oxide, Sodium Hydroxide, Povidone. 20 mg capsules: FD&C Blue No. 2, Sodium Hydroxide, Povidone. 30 mg capsules: FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, Sodium Hydroxide, Povidone. 40 mg capsules: Yellow Iron Oxide. 50 mg capsules: FD&C Blue No. 2, Red Iron Oxide, Sodium Hydroxide, Povidone.</Description>
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