{
"NDC": [
{
"NDCCode": "62559-758-04",
"PackageDescription": "118 mL in 1 BOTTLE (62559-758-04) ",
"NDC11Code": "62559-0758-04",
"ProductNDC": "62559-758",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"NonProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240905",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA011265",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "6.25; 15",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240905",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (teaspoon) of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution contains 6.25 mg promethazine hydrochloride USP and 15 mg dextromethorphan hydrobromide USP in a flavored syrup base with a pH between 4.5 and 5.5. The inactive ingredients present are alcohol 7% (v/v), ascorbic acid, citric acid, black currant flavor, D&C Yellow 10, edetate disodium, FD&C Yellow 6, glycerin, L-Menthol, sodium benzoate, sodium citrate, sodium propionate, saccharin sodium, sucrose, and water. Promethazine hydrochloride USP is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (+)- with the following structural formula. Promethazine hydrochloride USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol. Dextromethorphan hydrobromide USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α–morphinan hydrobromide monohydrate with the following structural formula. Dextromethorphan hydrobromide monohydrate occurs as white crystals, is sparingly soluble in water, and is freely soluble in alcohol. The empirical formula is C18H25NOHBrH2O, and the molecular weight of the monohydrate is 370.33. Dextromethorphan hydrobromide monohydrate is dextrorotatory with a specific rotation of +27.6 degrees in water (20 degrees C, sodium D-line)."
},
{
"NDCCode": "62559-153-04",
"PackageDescription": "118 mL in 1 BOTTLE (62559-153-04) ",
"NDC11Code": "62559-0153-04",
"ProductNDC": "62559-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opium Tincture Deodorized",
"NonProprietaryName": "Morphine Tincture",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110225",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "MORPHINE",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110225",
"SamplePackage": "N",
"IndicationAndUsage": "Opium tincture is useful for the treatment of diarrhea.",
"Description": "Opium Tincture, USP (Deodorized), is for oral administration. It is freed from unpleasant odor or nauseating substances by “denarcotization” with a petroleum distillate. Opium tincture is a clear, reddish-brown hydroalcoholic solution. Each 100 mL contains 1 g of anhydrous morphine (represents the equivalent of 10 g of Powdered Opium, USP), alcohol, 19%, and water. Opium has a very characteristic odor and a very bitter taste. The opiates are the most effective and prompt-acting nonspecific antidiarrheal agents."
},
{
"NDCCode": "62559-758-16",
"PackageDescription": "473 mL in 1 BOTTLE (62559-758-16) ",
"NDC11Code": "62559-0758-16",
"ProductNDC": "62559-758",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"NonProprietaryName": "Promethazine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240905",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA011265",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "6.25; 15",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240905",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.",
"Description": "Each 5 mL (teaspoon) of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution contains 6.25 mg promethazine hydrochloride USP and 15 mg dextromethorphan hydrobromide USP in a flavored syrup base with a pH between 4.5 and 5.5. The inactive ingredients present are alcohol 7% (v/v), ascorbic acid, citric acid, black currant flavor, D&C Yellow 10, edetate disodium, FD&C Yellow 6, glycerin, L-Menthol, sodium benzoate, sodium citrate, sodium propionate, saccharin sodium, sucrose, and water. Promethazine hydrochloride USP is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (+)- with the following structural formula. Promethazine hydrochloride USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol. Dextromethorphan hydrobromide USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α–morphinan hydrobromide monohydrate with the following structural formula. Dextromethorphan hydrobromide monohydrate occurs as white crystals, is sparingly soluble in water, and is freely soluble in alcohol. The empirical formula is C18H25NOHBrH2O, and the molecular weight of the monohydrate is 370.33. Dextromethorphan hydrobromide monohydrate is dextrorotatory with a specific rotation of +27.6 degrees in water (20 degrees C, sodium D-line)."
},
{
"NDCCode": "41250-758-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (41250-758-04) / 118 mL in 1 BOTTLE",
"NDC11Code": "41250-0758-04",
"ProductNDC": "41250-758",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Meijer Maximum Strength Nighttime Cough Dm",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20170314",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "MEIJER DISTRIBUTION INC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "30; 12.5",
"StrengthUnit": "mg/20mL; mg/20mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170314",
"SamplePackage": "N",
"IndicationAndUsage": "▪temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. ▪temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:▪runny nose▪sneezing▪itchy, watery eyes▪itching of the nose or throat. ▪controls the impulse to cough to help you sleep."
},
{
"NDCCode": "55648-758-04",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (55648-758-04) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55648-0758-04",
"ProductNDC": "55648-758",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20070327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077942",
"LabelerName": "WOCKHARDT LIMITED",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59011-758-04",
"PackageDescription": "4 POUCH in 1 CARTON (59011-758-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH",
"NDC11Code": "59011-0758-04",
"ProductNDC": "59011-758",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Butrans",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20110214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021306",
"LabelerName": "Knoa Pharma LLC",
"SubstanceName": "BUPRENORPHINE",
"StrengthNumber": "15",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110214",
"SamplePackage": "N",
"IndicationAndUsage": "BUTRANS is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 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 and Precautions (5.1)], reserve opioid analgesics, including BUTRANS, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 BUTRANS is not indicated as an as-needed (prn) analgesic.",
"Description": "BUTRANS is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of BUTRANS are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. BUTRANS is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of BUTRANS (not to scale). The active ingredient in BUTRANS is buprenorphine. The inactive ingredients in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate cross-linked with aluminum."
},
{
"NDCCode": "63545-758-04",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (63545-758-04) ",
"NDC11Code": "63545-0758-04",
"ProductNDC": "63545-758",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aesculus Hippocastanum",
"NonProprietaryName": "Aesculus Hippocastanum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "HORSE CHESTNUT",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200123",
"SamplePackage": "N"
},
{
"NDCCode": "64679-758-04",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-04) > 1 mL in 1 VIAL, SINGLE-DOSE (64679-758-11) ",
"NDC11Code": "64679-0758-04",
"ProductNDC": "64679-758",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20070327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077942",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20070327",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).",
"Description": "Ketorolac tromethamine, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural formula is presented in Figure 1. FIGURE 1. C15H13NO3 . C4H11NO3. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, 8.70 mg respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color."
},
{
"NDCCode": "70069-758-04",
"PackageDescription": "4 VIAL in 1 CARTON (70069-758-04) / 4 mL in 1 VIAL",
"NDC11Code": "70069-0758-04",
"ProductNDC": "70069-758",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218112",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240926",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmedetomidine Injection is a alpha2 adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).",
"Description": "Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine Injection contains the dexmedetomidine as active pharmaceutical ingredient in the form of the hydrochloride salt form. Dexmedetomidine hydrochloride is a central alpha-2 adrenergic agonist. Structurally it is the S-enantiomer of medetomidine and is chemically described as 4-[(S)-α,2,3-Trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white crystalline powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 118 mcg of dexmedetomidine hydrochloride USP, equivalent to 100 mcg (0.1 mg) of dexmedetomidine, 1.6 mg of methylparaben NF and 0.2 mg of propylparaben NF, as preservatives and 9 mg of sodium chloride USP, as tonicity agent in water for injection."
},
{
"NDCCode": "62559-1106-6",
"PackageDescription": "473 mL in 1 BOTTLE (62559-1106-6)",
"NDC11Code": "62559-1106-06",
"ProductNDC": "62559-1106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoclopramide",
"NonProprietaryName": "Metoclopramide Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110310",
"EndMarketingDate": "20140331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071402",
"LabelerName": "ANIP Acquisition Company",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-04-03"
},
{
"NDCCode": "62559-111-07",
"PackageDescription": "7 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) / 60 mL in 1 BOTTLE, UNIT-DOSE",
"NDC11Code": "62559-0111-07",
"ProductNDC": "62559-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cortenema",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "ENEMA",
"RouteName": "RECTAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016199",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/60mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120810",
"SamplePackage": "N",
"IndicationAndUsage": "CORTENEMA® is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.",
"Description": "Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-trihydroxy,(11β)-and the following structural formula:. CORTENEMA® is a convenient disposable single-dose hydrocortisone enema designed for ease of self-administration. Each disposable unit (60 mL) contains: Hydrocortisone, 100 mg in an aqueous solution containing carbomer 934P, polysorbate 80, purified water, sodium hydroxide and methylparaben, 0.18% as a preservative."
},
{
"NDCCode": "62559-111-11",
"PackageDescription": "1 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-11) / 60 mL in 1 BOTTLE, UNIT-DOSE",
"NDC11Code": "62559-0111-11",
"ProductNDC": "62559-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cortenema",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "ENEMA",
"RouteName": "RECTAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016199",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/60mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120810",
"SamplePackage": "N",
"IndicationAndUsage": "CORTENEMA® is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.",
"Description": "Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-trihydroxy,(11β)-and the following structural formula:. CORTENEMA® is a convenient disposable single-dose hydrocortisone enema designed for ease of self-administration. Each disposable unit (60 mL) contains: Hydrocortisone, 100 mg in an aqueous solution containing carbomer 934P, polysorbate 80, purified water, sodium hydroxide and methylparaben, 0.18% as a preservative."
},
{
"NDCCode": "62559-138-07",
"PackageDescription": "7 BOTTLE in 1 BOX (62559-138-07) / 60 mL in 1 BOTTLE (62559-138-11) ",
"NDC11Code": "62559-0138-07",
"ProductNDC": "62559-138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "ENEMA",
"RouteName": "RECTAL",
"StartMarketingDate": "20120816",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA016199",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/60mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120816",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocortisone Rectal Suspension, USP is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.",
"Description": "Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11β)- and the following structural formula. Hydrocortisone Rectal Suspension, USP is a convenient disposable single-dose hydrocortisone enema designed for ease of self-administration. Each disposable unit (60 mL) contains: Hydrocortisone, 100 mg in an aqueous solution containing carbomer 934P, polysorbate 80, purified water, sodium hydroxide and methylparaben, 0.18% as a preservative."
},
{
"NDCCode": "62559-210-31",
"PackageDescription": "30 CAPSULE in 1 CARTON (62559-210-31) ",
"NDC11Code": "62559-0210-31",
"ProductNDC": "62559-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nimodipine",
"NonProprietaryName": "Nimodipine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201832",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "NIMODIPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20151101",
"SamplePackage": "N"
},
{
"NDCCode": "62559-235-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (62559-235-01) ",
"NDC11Code": "62559-0235-01",
"ProductNDC": "62559-235",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dipyridamole",
"NonProprietaryName": "Dipyridamole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211122",
"EndMarketingDate": "20240331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086944",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "DIPYRIDAMOLE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211122",
"EndMarketingDatePackage": "20240331",
"SamplePackage": "N",
"IndicationAndUsage": "Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.",
"Description": "Dipyridamole Tablets USP are a platelet inhibitor chemically described as 2,2',2'',2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula. Dipyridamole is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water. Dipyridamole Tablets USP for oral administration contain. Active Ingredient TABLETS 25 mg, 50 mg, and 75 mg: dipyridamole USP 25 mg, 50 mg and 75 mg, respectively. Inactive Ingredients TABLETS 25 mg, 50 mg, and 75 mg: corn starch, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "62559-252-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (62559-252-01) ",
"NDC11Code": "62559-0252-01",
"ProductNDC": "62559-252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075147",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260327",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide Mononitrate Tablets USP are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide mononitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for Isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula. Isosorbide Mononitrate Tablets USP, for oral administration, are available in 10 mg and 20 mg tablets. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc. The 20 mg tablets also contain D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, and FD&C blue #2 aluminum lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "62559-253-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (62559-253-01) ",
"NDC11Code": "62559-0253-01",
"ProductNDC": "62559-253",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075147",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260327",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide Mononitrate Tablets USP are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide mononitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for Isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula. Isosorbide Mononitrate Tablets USP, for oral administration, are available in 10 mg and 20 mg tablets. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc. The 20 mg tablets also contain D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, and FD&C blue #2 aluminum lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "62559-266-16",
"PackageDescription": "473 mL in 1 BOTTLE (62559-266-16) ",
"NDC11Code": "62559-0266-16",
"ProductNDC": "62559-266",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valproic Acid",
"NonProprietaryName": "Valproic Acid",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240102",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073178",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "VALPROIC ACID",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240102",
"SamplePackage": "N",
"IndicationAndUsage": "Valproic acid oral solution is indicated for: 1 Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1).",
"Description": "Valproic acid is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid. Valproic acid has the following structure. Valproic acid (pKa 4.8) has a molecular weight of 144 and occurs as a colorless liquid with a characteristic odor. It is slightly soluble in water (1.3 mg/mL) and very soluble in organic solvents. Valproic acid oral solution USP is an antiepileptic for oral administration. Valproic acid oral solution USP contains the equivalent of 250 mg valproic acid per 5 mL as the sodium salt. Inactive Ingredients. FD&C Red No. 40, glycerin, methylparaben, propylparaben, sodium hydroxide, sorbitol, sucrose, purified water, sour cherry flavor and alcohol 0.02% (v/v)."
},
{
"NDCCode": "62559-288-15",
"PackageDescription": "1 TUBE in 1 CARTON (62559-288-15) / 15 g in 1 TUBE",
"NDC11Code": "62559-0288-15",
"ProductNDC": "62559-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240508",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA012787",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240508",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinolone Acetonide Cream USP, 0.01% and 0.025% are intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Cream USP, 0.01% contains 0.1 mg/g of fluocinolone acetonide USP and Fluocinolone Acetonide Cream USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax."
},
{
"NDCCode": "62559-288-60",
"PackageDescription": "1 TUBE in 1 CARTON (62559-288-60) / 60 g in 1 TUBE",
"NDC11Code": "62559-0288-60",
"ProductNDC": "62559-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240508",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA012787",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240508",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinolone Acetonide Cream USP, 0.01% and 0.025% are intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Cream USP, 0.01% contains 0.1 mg/g of fluocinolone acetonide USP and Fluocinolone Acetonide Cream USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax."
},
{
"NDCCode": "62559-289-15",
"PackageDescription": "1 TUBE in 1 CARTON (62559-289-15) / 15 g in 1 TUBE",
"NDC11Code": "62559-0289-15",
"ProductNDC": "62559-289",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240508",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA012787",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240508",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinolone Acetonide Cream USP, 0.01% and 0.025% are intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Cream USP, 0.01% contains 0.1 mg/g of fluocinolone acetonide USP and Fluocinolone Acetonide Cream USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax."
},
{
"NDCCode": "62559-289-60",
"PackageDescription": "1 TUBE in 1 CARTON (62559-289-60) / 60 g in 1 TUBE",
"NDC11Code": "62559-0289-60",
"ProductNDC": "62559-289",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240508",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA012787",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240508",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinolone Acetonide Cream USP, 0.01% and 0.025% are intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Cream USP, 0.01% contains 0.1 mg/g of fluocinolone acetonide USP and Fluocinolone Acetonide Cream USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax."
},
{
"NDCCode": "62559-299-15",
"PackageDescription": "1 TUBE in 1 CARTON (62559-299-15) / 15 g in 1 TUBE",
"NDC11Code": "62559-0299-15",
"ProductNDC": "62559-299",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231113",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA013960",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231116",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinolone Acetonide Ointment USP, 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Ointment USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a white petrolatum USP vehicle."
},
{
"NDCCode": "62559-299-60",
"PackageDescription": "1 TUBE in 1 CARTON (62559-299-60) / 60 g in 1 TUBE",
"NDC11Code": "62559-0299-60",
"ProductNDC": "62559-299",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231113",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA013960",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231116",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinolone Acetonide Ointment USP, 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Ointment USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a white petrolatum USP vehicle."
},
{
"NDCCode": "62559-325-26",
"PackageDescription": "6 TUBE in 1 CARTON (62559-325-26) / 2 g in 1 TUBE",
"NDC11Code": "62559-0325-26",
"ProductNDC": "62559-325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pandel",
"NonProprietaryName": "Hydrocortisone Probutate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220930",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020453",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCORTISONE PROBUTATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220930",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "Y",
"IndicationAndUsage": "PANDEL® (hydrocortisone probutate) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.",
"Description": "PANDEL (hydrocortisone probutate) Cream, 0.1% contains hydrocortisone probutate, a synthetic corticosteroid. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone probutate is a tasteless and odorless white crystalline powder practically insoluble in hexane or water, slightly soluble in ether, and very soluble in dichloromethane, methanol and acetone. Chemically, it is 11ß,17,21-trihydroxypregn-4-ene-3,20-dione 17-butyrate 21-propionate. The structural formula is. Molecular Formula: C28H40O7Molecular Weight: 488.62. Each gram of PANDEL (hydrocortisone probutate) Cream, 0.1% contains: 1 mg of hydrocortisone probutate in a cream base of propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water."
},
{
"NDCCode": "62559-325-80",
"PackageDescription": "1 TUBE in 1 CARTON (62559-325-80) / 80 g in 1 TUBE",
"NDC11Code": "62559-0325-80",
"ProductNDC": "62559-325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pandel",
"NonProprietaryName": "Hydrocortisone Probutate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220930",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020453",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "HYDROCORTISONE PROBUTATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220930",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "PANDEL® (hydrocortisone probutate) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.",
"Description": "PANDEL (hydrocortisone probutate) Cream, 0.1% contains hydrocortisone probutate, a synthetic corticosteroid. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone probutate is a tasteless and odorless white crystalline powder practically insoluble in hexane or water, slightly soluble in ether, and very soluble in dichloromethane, methanol and acetone. Chemically, it is 11ß,17,21-trihydroxypregn-4-ene-3,20-dione 17-butyrate 21-propionate. The structural formula is. Molecular Formula: C28H40O7Molecular Weight: 488.62. Each gram of PANDEL (hydrocortisone probutate) Cream, 0.1% contains: 1 mg of hydrocortisone probutate in a cream base of propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water."
},
{
"NDCCode": "62559-390-20",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (62559-390-20) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "62559-0390-20",
"ProductNDC": "62559-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151026",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050606",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections., 2 Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.",
"Description": "Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients. Vancomycin hydrochloride has the structural formula:."
},
{
"NDCCode": "62559-390-50",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (62559-390-50) ",
"NDC11Code": "62559-0390-50",
"ProductNDC": "62559-390",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
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"RouteName": "ORAL",
"StartMarketingDate": "20151026",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050606",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161220",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections., 2 Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.",
"Description": "Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients. Vancomycin hydrochloride has the structural formula:."
},
{
"NDCCode": "62559-391-20",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (62559-391-20) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "62559-0391-20",
"ProductNDC": "62559-391",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151026",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050606",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151026",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections., 2 Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.",
"Description": "Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients. Vancomycin hydrochloride has the structural formula:."
},
{
"NDCCode": "62559-391-50",
"PackageDescription": "50 CAPSULE in 1 BOTTLE (62559-391-50) ",
"NDC11Code": "62559-0391-50",
"ProductNDC": "62559-391",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151026",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050606",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161220",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections., 2 Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.",
"Description": "Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients. Vancomycin hydrochloride has the structural formula:."
}
]
}
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<NDCList>
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<NDC11Code>62559-0758-04</NDC11Code>
<ProductNDC>62559-758</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</ProprietaryName>
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<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (teaspoon) of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution contains 6.25 mg promethazine hydrochloride USP and 15 mg dextromethorphan hydrobromide USP in a flavored syrup base with a pH between 4.5 and 5.5. The inactive ingredients present are alcohol 7% (v/v), ascorbic acid, citric acid, black currant flavor, D&C Yellow 10, edetate disodium, FD&C Yellow 6, glycerin, L-Menthol, sodium benzoate, sodium citrate, sodium propionate, saccharin sodium, sucrose, and water. Promethazine hydrochloride USP is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (+)- with the following structural formula. Promethazine hydrochloride USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol. Dextromethorphan hydrobromide USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α–morphinan hydrobromide monohydrate with the following structural formula. Dextromethorphan hydrobromide monohydrate occurs as white crystals, is sparingly soluble in water, and is freely soluble in alcohol. The empirical formula is C18H25NOHBrH2O, and the molecular weight of the monohydrate is 370.33. Dextromethorphan hydrobromide monohydrate is dextrorotatory with a specific rotation of +27.6 degrees in water (20 degrees C, sodium D-line).</Description>
</NDC>
<NDC>
<NDCCode>62559-153-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (62559-153-04) </PackageDescription>
<NDC11Code>62559-0153-04</NDC11Code>
<ProductNDC>62559-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opium Tincture Deodorized</ProprietaryName>
<NonProprietaryName>Morphine Tincture</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110225</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MORPHINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Opium tincture is useful for the treatment of diarrhea.</IndicationAndUsage>
<Description>Opium Tincture, USP (Deodorized), is for oral administration. It is freed from unpleasant odor or nauseating substances by “denarcotization” with a petroleum distillate. Opium tincture is a clear, reddish-brown hydroalcoholic solution. Each 100 mL contains 1 g of anhydrous morphine (represents the equivalent of 10 g of Powdered Opium, USP), alcohol, 19%, and water. Opium has a very characteristic odor and a very bitter taste. The opiates are the most effective and prompt-acting nonspecific antidiarrheal agents.</Description>
</NDC>
<NDC>
<NDCCode>62559-758-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (62559-758-16) </PackageDescription>
<NDC11Code>62559-0758-16</NDC11Code>
<ProductNDC>62559-758</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Dextromethorphan Hydrobromide</ProprietaryName>
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<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
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<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.</IndicationAndUsage>
<Description>Each 5 mL (teaspoon) of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution contains 6.25 mg promethazine hydrochloride USP and 15 mg dextromethorphan hydrobromide USP in a flavored syrup base with a pH between 4.5 and 5.5. The inactive ingredients present are alcohol 7% (v/v), ascorbic acid, citric acid, black currant flavor, D&C Yellow 10, edetate disodium, FD&C Yellow 6, glycerin, L-Menthol, sodium benzoate, sodium citrate, sodium propionate, saccharin sodium, sucrose, and water. Promethazine hydrochloride USP is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride, (+)- with the following structural formula. Promethazine hydrochloride USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol. Dextromethorphan hydrobromide USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α–morphinan hydrobromide monohydrate with the following structural formula. Dextromethorphan hydrobromide monohydrate occurs as white crystals, is sparingly soluble in water, and is freely soluble in alcohol. The empirical formula is C18H25NOHBrH2O, and the molecular weight of the monohydrate is 370.33. Dextromethorphan hydrobromide monohydrate is dextrorotatory with a specific rotation of +27.6 degrees in water (20 degrees C, sodium D-line).</Description>
</NDC>
<NDC>
<NDCCode>41250-758-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41250-758-04) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>41250-0758-04</NDC11Code>
<ProductNDC>41250-758</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Meijer Maximum Strength Nighttime Cough Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170314</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>MEIJER DISTRIBUTION INC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>30; 12.5</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>▪temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. ▪temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:▪runny nose▪sneezing▪itchy, watery eyes▪itching of the nose or throat. ▪controls the impulse to cough to help you sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55648-758-04</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (55648-758-04) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55648-0758-04</NDC11Code>
<ProductNDC>55648-758</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20070327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077942</ApplicationNumber>
<LabelerName>WOCKHARDT LIMITED</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59011-758-04</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (59011-758-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH</PackageDescription>
<NDC11Code>59011-0758-04</NDC11Code>
<ProductNDC>59011-758</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Butrans</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20110214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021306</ApplicationNumber>
<LabelerName>Knoa Pharma LLC</LabelerName>
<SubstanceName>BUPRENORPHINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BUTRANS is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: 1 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 and Precautions (5.1)], reserve opioid analgesics, including BUTRANS, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 BUTRANS is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>BUTRANS is a transdermal system providing systemic delivery of buprenorphine, a mu opioid partial agonist analgesic, continuously for 7 days. The chemical name of buprenorphine is 6,14-ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)- α-(1,1-dimethylethyl)-4, 5-epoxy-18, 19-dihydro-3-hydroxy-6-methoxy-α-methyl-, [5α, 7α, (S)]. The structural formula is. The molecular weight of buprenorphine is 467.6; the empirical formula is C29H41NO4. Buprenorphine occurs as a white or almost white powder and is very slightly soluble in water, freely soluble in acetone, soluble in methanol and ether, and slightly soluble in cyclohexane. The pKa is 8.5 and the melting point is about 217°C. System Components and Structure. Five different strengths of BUTRANS are available: 5, 7.5, 10, 15, and 20 mcg/hour (Table 6). The proportion of buprenorphine mixed in the adhesive matrix is the same in each of the five strengths. The amount of buprenorphine released from each system per hour is proportional to the active surface area of the system. The skin is the limiting barrier to diffusion from the system into the bloodstream. BUTRANS is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. Proceeding from the outer surface toward the surface adhering to the skin, the layers are (1) a beige-colored web backing layer; (2) an adhesive rim without buprenorphine; (3) a separating layer over the buprenorphine-containing adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a peel-off release liner. Before use, the release liner covering the adhesive layer is removed and discarded. Figure 1: Cross-Section Diagram of BUTRANS (not to scale). The active ingredient in BUTRANS is buprenorphine. The inactive ingredients in each system are: levulinic acid, oleyl oleate, povidone, and polyacrylate cross-linked with aluminum.</Description>
</NDC>
<NDC>
<NDCCode>63545-758-04</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (63545-758-04) </PackageDescription>
<NDC11Code>63545-0758-04</NDC11Code>
<ProductNDC>63545-758</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aesculus Hippocastanum</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>HORSE CHESTNUT</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64679-758-04</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-04) > 1 mL in 1 VIAL, SINGLE-DOSE (64679-758-11) </PackageDescription>
<NDC11Code>64679-0758-04</NDC11Code>
<ProductNDC>64679-758</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20070327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077942</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).</IndicationAndUsage>
<Description>Ketorolac tromethamine, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural formula is presented in Figure 1. FIGURE 1. C15H13NO3 . C4H11NO3. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, 8.70 mg respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.</Description>
</NDC>
<NDC>
<NDCCode>70069-758-04</NDCCode>
<PackageDescription>4 VIAL in 1 CARTON (70069-758-04) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>70069-0758-04</NDC11Code>
<ProductNDC>70069-758</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218112</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmedetomidine Injection is a alpha2 adrenergic receptor agonist indicated for: 1 Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection by continuous infusion not to exceed 24 hours. (1.1), 2 Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2).</IndicationAndUsage>
<Description>Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine Injection contains the dexmedetomidine as active pharmaceutical ingredient in the form of the hydrochloride salt form. Dexmedetomidine hydrochloride is a central alpha-2 adrenergic agonist. Structurally it is the S-enantiomer of medetomidine and is chemically described as 4-[(S)-α,2,3-Trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C13H16N2 HCl and the structural formula is. Dexmedetomidine hydrochloride is a white or almost white crystalline powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7. Each mL contains 118 mcg of dexmedetomidine hydrochloride USP, equivalent to 100 mcg (0.1 mg) of dexmedetomidine, 1.6 mg of methylparaben NF and 0.2 mg of propylparaben NF, as preservatives and 9 mg of sodium chloride USP, as tonicity agent in water for injection.</Description>
</NDC>
<NDC>
<NDCCode>62559-1106-6</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (62559-1106-6)</PackageDescription>
<NDC11Code>62559-1106-06</NDC11Code>
<ProductNDC>62559-1106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoclopramide</ProprietaryName>
<NonProprietaryName>Metoclopramide Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110310</StartMarketingDate>
<EndMarketingDate>20140331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071402</ApplicationNumber>
<LabelerName>ANIP Acquisition Company</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>62559-111-07</NDCCode>
<PackageDescription>7 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-07) / 60 mL in 1 BOTTLE, UNIT-DOSE</PackageDescription>
<NDC11Code>62559-0111-07</NDC11Code>
<ProductNDC>62559-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cortenema</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>ENEMA</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20120810</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016199</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/60mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CORTENEMA® is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.</IndicationAndUsage>
<Description>Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-trihydroxy,(11β)-and the following structural formula:. CORTENEMA® is a convenient disposable single-dose hydrocortisone enema designed for ease of self-administration. Each disposable unit (60 mL) contains: Hydrocortisone, 100 mg in an aqueous solution containing carbomer 934P, polysorbate 80, purified water, sodium hydroxide and methylparaben, 0.18% as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>62559-111-11</NDCCode>
<PackageDescription>1 BOTTLE, UNIT-DOSE in 1 CARTON (62559-111-11) / 60 mL in 1 BOTTLE, UNIT-DOSE</PackageDescription>
<NDC11Code>62559-0111-11</NDC11Code>
<ProductNDC>62559-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cortenema</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>ENEMA</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20120810</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016199</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/60mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CORTENEMA® is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.</IndicationAndUsage>
<Description>Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-trihydroxy,(11β)-and the following structural formula:. CORTENEMA® is a convenient disposable single-dose hydrocortisone enema designed for ease of self-administration. Each disposable unit (60 mL) contains: Hydrocortisone, 100 mg in an aqueous solution containing carbomer 934P, polysorbate 80, purified water, sodium hydroxide and methylparaben, 0.18% as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>62559-138-07</NDCCode>
<PackageDescription>7 BOTTLE in 1 BOX (62559-138-07) / 60 mL in 1 BOTTLE (62559-138-11) </PackageDescription>
<NDC11Code>62559-0138-07</NDC11Code>
<ProductNDC>62559-138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>ENEMA</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20120816</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA016199</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/60mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocortisone Rectal Suspension, USP is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.</IndicationAndUsage>
<Description>Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11β)- and the following structural formula. Hydrocortisone Rectal Suspension, USP is a convenient disposable single-dose hydrocortisone enema designed for ease of self-administration. Each disposable unit (60 mL) contains: Hydrocortisone, 100 mg in an aqueous solution containing carbomer 934P, polysorbate 80, purified water, sodium hydroxide and methylparaben, 0.18% as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>62559-210-31</NDCCode>
<PackageDescription>30 CAPSULE in 1 CARTON (62559-210-31) </PackageDescription>
<NDC11Code>62559-0210-31</NDC11Code>
<ProductNDC>62559-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nimodipine</ProprietaryName>
<NonProprietaryName>Nimodipine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201832</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NIMODIPINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62559-235-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (62559-235-01) </PackageDescription>
<NDC11Code>62559-0235-01</NDC11Code>
<ProductNDC>62559-235</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dipyridamole</ProprietaryName>
<NonProprietaryName>Dipyridamole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211122</StartMarketingDate>
<EndMarketingDate>20240331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086944</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211122</StartMarketingDatePackage>
<EndMarketingDatePackage>20240331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.</IndicationAndUsage>
<Description>Dipyridamole Tablets USP are a platelet inhibitor chemically described as 2,2',2'',2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula. Dipyridamole is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water. Dipyridamole Tablets USP for oral administration contain. Active Ingredient TABLETS 25 mg, 50 mg, and 75 mg: dipyridamole USP 25 mg, 50 mg and 75 mg, respectively. Inactive Ingredients TABLETS 25 mg, 50 mg, and 75 mg: corn starch, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62559-252-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (62559-252-01) </PackageDescription>
<NDC11Code>62559-0252-01</NDC11Code>
<ProductNDC>62559-252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075147</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide Mononitrate Tablets USP are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide mononitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for Isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula. Isosorbide Mononitrate Tablets USP, for oral administration, are available in 10 mg and 20 mg tablets. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc. The 20 mg tablets also contain D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, and FD&C blue #2 aluminum lake. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>62559-253-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (62559-253-01) </PackageDescription>
<NDC11Code>62559-0253-01</NDC11Code>
<ProductNDC>62559-253</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075147</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide Mononitrate Tablets USP are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide mononitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for Isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula. Isosorbide Mononitrate Tablets USP, for oral administration, are available in 10 mg and 20 mg tablets. Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide, and talc. The 20 mg tablets also contain D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, and FD&C blue #2 aluminum lake. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>62559-266-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (62559-266-16) </PackageDescription>
<NDC11Code>62559-0266-16</NDC11Code>
<ProductNDC>62559-266</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valproic Acid</ProprietaryName>
<NonProprietaryName>Valproic Acid</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240102</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073178</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALPROIC ACID</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valproic acid oral solution is indicated for: 1 Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1).</IndicationAndUsage>
<Description>Valproic acid is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid. Valproic acid has the following structure. Valproic acid (pKa 4.8) has a molecular weight of 144 and occurs as a colorless liquid with a characteristic odor. It is slightly soluble in water (1.3 mg/mL) and very soluble in organic solvents. Valproic acid oral solution USP is an antiepileptic for oral administration. Valproic acid oral solution USP contains the equivalent of 250 mg valproic acid per 5 mL as the sodium salt. Inactive Ingredients. FD&C Red No. 40, glycerin, methylparaben, propylparaben, sodium hydroxide, sorbitol, sucrose, purified water, sour cherry flavor and alcohol 0.02% (v/v).</Description>
</NDC>
<NDC>
<NDCCode>62559-288-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62559-288-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>62559-0288-15</NDC11Code>
<ProductNDC>62559-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240508</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA012787</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Cream USP, 0.01% and 0.025% are intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Cream USP, 0.01% contains 0.1 mg/g of fluocinolone acetonide USP and Fluocinolone Acetonide Cream USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax.</Description>
</NDC>
<NDC>
<NDCCode>62559-288-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62559-288-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>62559-0288-60</NDC11Code>
<ProductNDC>62559-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240508</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA012787</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Cream USP, 0.01% and 0.025% are intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Cream USP, 0.01% contains 0.1 mg/g of fluocinolone acetonide USP and Fluocinolone Acetonide Cream USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax.</Description>
</NDC>
<NDC>
<NDCCode>62559-289-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62559-289-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>62559-0289-15</NDC11Code>
<ProductNDC>62559-289</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240508</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA012787</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Cream USP, 0.01% and 0.025% are intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Cream USP, 0.01% contains 0.1 mg/g of fluocinolone acetonide USP and Fluocinolone Acetonide Cream USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax.</Description>
</NDC>
<NDC>
<NDCCode>62559-289-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62559-289-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>62559-0289-60</NDC11Code>
<ProductNDC>62559-289</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240508</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA012787</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Cream USP, 0.01% and 0.025% are intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Cream USP, 0.01% contains 0.1 mg/g of fluocinolone acetonide USP and Fluocinolone Acetonide Cream USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white wax.</Description>
</NDC>
<NDC>
<NDCCode>62559-299-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62559-299-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>62559-0299-15</NDC11Code>
<ProductNDC>62559-299</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231113</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA013960</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Ointment USP, 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Ointment USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a white petrolatum USP vehicle.</Description>
</NDC>
<NDC>
<NDCCode>62559-299-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62559-299-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>62559-0299-60</NDC11Code>
<ProductNDC>62559-299</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231113</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA013960</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Ointment USP, 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinolone Acetonide Ointment USP, 0.025% contains 0.25 mg/g of fluocinolone acetonide USP in a white petrolatum USP vehicle.</Description>
</NDC>
<NDC>
<NDCCode>62559-325-26</NDCCode>
<PackageDescription>6 TUBE in 1 CARTON (62559-325-26) / 2 g in 1 TUBE</PackageDescription>
<NDC11Code>62559-0325-26</NDC11Code>
<ProductNDC>62559-325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pandel</ProprietaryName>
<NonProprietaryName>Hydrocortisone Probutate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220930</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020453</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE PROBUTATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220930</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PANDEL® (hydrocortisone probutate) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.</IndicationAndUsage>
<Description>PANDEL (hydrocortisone probutate) Cream, 0.1% contains hydrocortisone probutate, a synthetic corticosteroid. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone probutate is a tasteless and odorless white crystalline powder practically insoluble in hexane or water, slightly soluble in ether, and very soluble in dichloromethane, methanol and acetone. Chemically, it is 11ß,17,21-trihydroxypregn-4-ene-3,20-dione 17-butyrate 21-propionate. The structural formula is. Molecular Formula: C28H40O7Molecular Weight: 488.62. Each gram of PANDEL (hydrocortisone probutate) Cream, 0.1% contains: 1 mg of hydrocortisone probutate in a cream base of propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>62559-325-80</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62559-325-80) / 80 g in 1 TUBE</PackageDescription>
<NDC11Code>62559-0325-80</NDC11Code>
<ProductNDC>62559-325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pandel</ProprietaryName>
<NonProprietaryName>Hydrocortisone Probutate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220930</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020453</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE PROBUTATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220930</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PANDEL® (hydrocortisone probutate) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.</IndicationAndUsage>
<Description>PANDEL (hydrocortisone probutate) Cream, 0.1% contains hydrocortisone probutate, a synthetic corticosteroid. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone probutate is a tasteless and odorless white crystalline powder practically insoluble in hexane or water, slightly soluble in ether, and very soluble in dichloromethane, methanol and acetone. Chemically, it is 11ß,17,21-trihydroxypregn-4-ene-3,20-dione 17-butyrate 21-propionate. The structural formula is. Molecular Formula: C28H40O7Molecular Weight: 488.62. Each gram of PANDEL (hydrocortisone probutate) Cream, 0.1% contains: 1 mg of hydrocortisone probutate in a cream base of propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>62559-390-20</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (62559-390-20) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62559-0390-20</NDC11Code>
<ProductNDC>62559-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151026</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050606</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections., 2 Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients. Vancomycin hydrochloride has the structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>62559-390-50</NDCCode>
<PackageDescription>50 CAPSULE in 1 BOTTLE (62559-390-50) </PackageDescription>
<NDC11Code>62559-0390-50</NDC11Code>
<ProductNDC>62559-390</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151026</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050606</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections., 2 Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients. Vancomycin hydrochloride has the structural formula:.</Description>
</NDC>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
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<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections., 2 Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients. Vancomycin hydrochloride has the structural formula:.</Description>
</NDC>
<NDC>
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<PackageDescription>50 CAPSULE in 1 BOTTLE (62559-391-50) </PackageDescription>
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<ProductNDC>62559-391</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
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<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age. Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections., 2 Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.</IndicationAndUsage>
<Description>Vancomycin Hydrochloride Capsules USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). The capsules also contain FD&C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients. Vancomycin hydrochloride has the structural formula:.</Description>
</NDC>
</NDCList>