{
"NDC": [
{
"NDCCode": "53002-1212-0",
"PackageDescription": "100 TABLET in 1 BOTTLE (53002-1212-0) ",
"NDC11Code": "53002-1212-00",
"ProductNDC": "53002-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021210",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N"
},
{
"NDCCode": "53002-1212-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (53002-1212-3) ",
"NDC11Code": "53002-1212-03",
"ProductNDC": "53002-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021210",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N"
},
{
"NDCCode": "50090-1212-0",
"PackageDescription": "30 TABLET in 1 BOTTLE (50090-1212-0)",
"NDC11Code": "50090-1212-00",
"ProductNDC": "50090-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040663",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-10-19"
},
{
"NDCCode": "53360-1212-0",
"PackageDescription": "15000 CAPSULE, EXTENDED RELEASE in 1 DRUM (53360-1212-0) ",
"NDC11Code": "53360-1212-00",
"ProductNDC": "53360-1212",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"StartMarketingDate": "20120301",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Sanofi Winthrop Industrie",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2023-01-24",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "01-MAR-12"
},
{
"NDCCode": "70518-1212-0",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (70518-1212-0) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "70518-1212-00",
"ProductNDC": "70518-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alyacen 1/35",
"NonProprietaryName": "Norethindrone And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091634",
"LabelerName": "REMEDYREPACK INC.",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180516",
"SamplePackage": "N"
},
{
"NDCCode": "0032-1212-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1212-01) ",
"NDC11Code": "00032-1212-01",
"ProductNDC": "0032-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20090430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020725",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "60000; 12000; 38000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090430",
"SamplePackage": "N",
"IndicationAndUsage": "CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
"Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate."
},
{
"NDCCode": "0032-1212-07",
"PackageDescription": "250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1212-07) ",
"NDC11Code": "00032-1212-07",
"ProductNDC": "0032-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20090430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020725",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "60000; 12000; 38000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090430",
"SamplePackage": "N",
"IndicationAndUsage": "CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
"Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate."
},
{
"NDCCode": "0032-1212-13",
"PackageDescription": "1 BOTTLE in 1 CARTON (0032-1212-13) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE",
"NDC11Code": "00032-1212-13",
"ProductNDC": "0032-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20090430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020725",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "60000; 12000; 38000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181120",
"SamplePackage": "Y",
"IndicationAndUsage": "CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
"Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate."
},
{
"NDCCode": "12496-1212-3",
"PackageDescription": "30 POUCH in 1 CARTON (12496-1212-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1212-1) ",
"NDC11Code": "12496-1212-03",
"ProductNDC": "12496-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suboxone",
"NonProprietaryName": "Buprenorphine Hydrochloride, Naloxone Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20120824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022410",
"LabelerName": "INDIVIOR INC.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "12; 3",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120824",
"SamplePackage": "N",
"IndicationAndUsage": "SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.",
"Description": "SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether."
},
{
"NDCCode": "17856-1212-1",
"PackageDescription": "1 CAPSULE, DELAYED RELEASE PELLETS in 1 POUCH (17856-1212-1)",
"NDC11Code": "17856-1212-01",
"ProductNDC": "17856-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Creon",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20100813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020725",
"LabelerName": "Atlantic Biologicals Corps",
"SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
"StrengthNumber": "12000; 38000; 60000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "CREON (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions. ®.",
"Description": "CREON is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases. Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether. Each delayed-release capsule for oral administration contains enteric-coated spheres (0.71–1.60 mm in diameter). The active ingredient evaluated in clinical trials is lipase. CREON is dosed by lipase units. Other active ingredients include protease and amylase. CREON contains the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate. 9,500 USP units of protease; 15,000 USP units of amylase delayed-release capsules have a white opaque cap with imprint “CREON 1203” and a white opaque body. The shells contain titanium dioxide and hypromellose. 3,000 USP units of lipase;. 19,000 USP units of protease; 30,000 USP units of amylase delayed-release capsules have a Swedish-orange opaque cap with imprint “CREON 1206” and a blue opaque body. The shells contain FD&C Blue No. 2, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. 6,000 USP units of lipase;. 38,000 USP units of protease; 60,000 USP units of amylase delayed-release capsules have a brown opaque cap with imprint “CREON 1212” and a colorless transparent body. The shells contain black iron oxide, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. 12,000 USP units of lipase;. 76,000 USP units of protease; 120,000 USP units of amylase delayed-release capsules have a Swedish-orange opaque cap with imprint “CREON 1224” and a colorless transparent body. The shells contain gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. 24,000 USP units of lipase;."
},
{
"NDCCode": "36987-1212-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1212-1)",
"NDC11Code": "36987-1212-01",
"ProductNDC": "36987-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flounder",
"NonProprietaryName": "Flounder",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "FLOUNDER",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1212-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1212-2)",
"NDC11Code": "36987-1212-02",
"ProductNDC": "36987-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flounder",
"NonProprietaryName": "Flounder",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "FLOUNDER",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1212-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1212-3)",
"NDC11Code": "36987-1212-03",
"ProductNDC": "36987-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flounder",
"NonProprietaryName": "Flounder",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "FLOUNDER",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1212-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1212-4)",
"NDC11Code": "36987-1212-04",
"ProductNDC": "36987-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flounder",
"NonProprietaryName": "Flounder",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "FLOUNDER",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "68071-1212-1",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (68071-1212-1) ",
"NDC11Code": "68071-1212-01",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1212-2",
"PackageDescription": "270 CAPSULE in 1 BOTTLE (68071-1212-2) ",
"NDC11Code": "68071-1212-02",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1212-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68071-1212-3) ",
"NDC11Code": "68071-1212-03",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1212-4",
"PackageDescription": "84 CAPSULE in 1 BOTTLE (68071-1212-4) ",
"NDC11Code": "68071-1212-04",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1212-5",
"PackageDescription": "14 CAPSULE in 1 BOTTLE (68071-1212-5) ",
"NDC11Code": "68071-1212-05",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1212-6",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (68071-1212-6) ",
"NDC11Code": "68071-1212-06",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1212-7",
"PackageDescription": "7 CAPSULE in 1 BOTTLE (68071-1212-7) ",
"NDC11Code": "68071-1212-07",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1212-8",
"PackageDescription": "180 CAPSULE in 1 BOTTLE (68071-1212-8) ",
"NDC11Code": "68071-1212-08",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "68071-1212-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (68071-1212-9) ",
"NDC11Code": "68071-1212-09",
"ProductNDC": "68071-1212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170324",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide."
},
{
"NDCCode": "53002-0060-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (53002-0060-0) ",
"NDC11Code": "53002-0060-00",
"ProductNDC": "53002-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201506",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital HerpesTreatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-infected patientsReduction of transmission, 3 Herpes Zoster.",
"Description": "Valacyclovir hydrochloride, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride, USP is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride, USP are 1.90, 7.47, and 9.43. Valacyclovir hydrochloride, USP comply with USP dissolution test 2."
},
{
"NDCCode": "53002-0061-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (53002-0061-0) ",
"NDC11Code": "53002-0061-00",
"ProductNDC": "53002-0061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090682",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) : 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission , 3 Herpes Zoster .",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "53002-0062-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (53002-0062-0) ",
"NDC11Code": "53002-0062-00",
"ProductNDC": "53002-0062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir",
"NonProprietaryName": "Valacyclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203047",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir tablet, USP is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission Herpes Zoster Pediatric Patients (1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use (1.3) The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride USP equivalent to 500 mg or 1gm valacyclovir and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate)is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. Valacyclovir Tablets USP, 500 gm and 1 g complies with USP dissolution test 2."
},
{
"NDCCode": "53002-0270-0",
"PackageDescription": "50 TABLET in 1 BOTTLE (53002-0270-0) ",
"NDC11Code": "53002-0270-00",
"ProductNDC": "53002-0270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203834",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
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"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration. Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&C blue lake # 2 Indigo carmine AL, respectively. Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-. It has the following structural formula:."
},
{
"NDCCode": "53002-0271-0",
"PackageDescription": "50 TABLET in 1 BOTTLE (53002-0271-0) ",
"NDC11Code": "53002-0271-00",
"ProductNDC": "53002-0271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075382",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200101",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:."
},
{
"NDCCode": "53002-0272-0",
"PackageDescription": "50 TABLET in 1 BOTTLE (53002-0272-0) ",
"NDC11Code": "53002-0272-00",
"ProductNDC": "53002-0272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209366",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir is indicated for the acute treatment of herpes zoster (shingles).",
"Description": "Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Tablets are formulations for oral administration. Each 800-mg tablet of acyclovir contains 800mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino -1, 9 -dihydro -9 - [(2-hydroxyethoxy) methyl]-6 H-purin-6 -one; it has the following structural formula."
},
{
"NDCCode": "53002-0670-0",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (53002-0670-0) ",
"NDC11Code": "53002-0670-00",
"ProductNDC": "53002-0670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204446",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
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<Status>Deprecated</Status>
<LastUpdate>2017-10-19</LastUpdate>
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<LabelerName>Sanofi Winthrop Industrie</LabelerName>
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<PackageDescription>3 BLISTER PACK in 1 CARTON (70518-1212-0) > 1 KIT in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alyacen 1/35</ProprietaryName>
<NonProprietaryName>Norethindrone And Ethinyl Estradiol</NonProprietaryName>
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<ApplicationNumber>ANDA091634</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-1212-01) </PackageDescription>
<NDC11Code>00032-1212-01</NDC11Code>
<ProductNDC>0032-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Creon</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020725</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
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<LastUpdate>2026-07-25</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<Description>Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.</Description>
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<MarketingCategoryName>BLA</MarketingCategoryName>
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<LabelerName>AbbVie Inc.</LabelerName>
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<LastUpdate>2026-07-25</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<Description>Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.</Description>
</NDC>
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<NDCCode>0032-1212-13</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0032-1212-13) / 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE</PackageDescription>
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<ApplicationNumber>BLA020725</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>60000; 12000; 38000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181120</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>CREON® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<Description>Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated spheres in CREON are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. CREON (pancrelipase) delayed-release capsules are for oral administration, include a two-piece shell containing tan-colored enteric-coated spheres (0.71 mm to 1.60 mm in diameter), and are available as follows:. 3,000 USP units of lipase; 9,500 USP units of protease; and 15,000 USP units of amylase; delayed-release capsules with shells that contain hypromellose and titanium dioxide, and that also may contain carrageenan and potassium chloride. 6,000 USP units of lipase; 19,000 USP units of protease; and 30,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2, red iron oxide, and yellow iron oxide. 12,000 USP units of lipase; 38,000 USP units of protease; and 60,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. 24,000 USP units of lipase; 76,000 USP units of protease; and 120,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, red iron oxide, and yellow iron oxide. 36,000 USP units of lipase; 114,000 USP units of protease; and 180,000 USP units of amylase; delayed-release capsules with shells that may contain gelatin, hypromellose, carrageenan, potassium chloride, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 1, and FD&C Blue No. 2. CREON (pancrelipase) delayed-release capsules include the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>12496-1212-3</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (12496-1212-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1212-1) </PackageDescription>
<NDC11Code>12496-1212-03</NDC11Code>
<ProductNDC>12496-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suboxone</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride, Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20120824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022410</ApplicationNumber>
<LabelerName>INDIVIOR INC.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12; 3</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
<Description>SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.</Description>
</NDC>
<NDC>
<NDCCode>17856-1212-1</NDCCode>
<PackageDescription>1 CAPSULE, DELAYED RELEASE PELLETS in 1 POUCH (17856-1212-1)</PackageDescription>
<NDC11Code>17856-1212-01</NDC11Code>
<ProductNDC>17856-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Creon</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020725</ApplicationNumber>
<LabelerName>Atlantic Biologicals Corps</LabelerName>
<SubstanceName>PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE</SubstanceName>
<StrengthNumber>12000; 38000; 60000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>CREON (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions. ®.</IndicationAndUsage>
<Description>CREON is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases. Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether. Each delayed-release capsule for oral administration contains enteric-coated spheres (0.71–1.60 mm in diameter). The active ingredient evaluated in clinical trials is lipase. CREON is dosed by lipase units. Other active ingredients include protease and amylase. CREON contains the following inactive ingredients: cetyl alcohol, dimethicone, hypromellose phthalate, polyethylene glycol, and triethyl citrate. 9,500 USP units of protease; 15,000 USP units of amylase delayed-release capsules have a white opaque cap with imprint “CREON 1203” and a white opaque body. The shells contain titanium dioxide and hypromellose. 3,000 USP units of lipase;. 19,000 USP units of protease; 30,000 USP units of amylase delayed-release capsules have a Swedish-orange opaque cap with imprint “CREON 1206” and a blue opaque body. The shells contain FD&C Blue No. 2, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. 6,000 USP units of lipase;. 38,000 USP units of protease; 60,000 USP units of amylase delayed-release capsules have a brown opaque cap with imprint “CREON 1212” and a colorless transparent body. The shells contain black iron oxide, gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. 12,000 USP units of lipase;. 76,000 USP units of protease; 120,000 USP units of amylase delayed-release capsules have a Swedish-orange opaque cap with imprint “CREON 1224” and a colorless transparent body. The shells contain gelatin, red iron oxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. 24,000 USP units of lipase;.</Description>
</NDC>
<NDC>
<NDCCode>36987-1212-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1212-1)</PackageDescription>
<NDC11Code>36987-1212-01</NDC11Code>
<ProductNDC>36987-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flounder</ProprietaryName>
<NonProprietaryName>Flounder</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>FLOUNDER</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1212-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1212-2)</PackageDescription>
<NDC11Code>36987-1212-02</NDC11Code>
<ProductNDC>36987-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flounder</ProprietaryName>
<NonProprietaryName>Flounder</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>FLOUNDER</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1212-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1212-3)</PackageDescription>
<NDC11Code>36987-1212-03</NDC11Code>
<ProductNDC>36987-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flounder</ProprietaryName>
<NonProprietaryName>Flounder</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>FLOUNDER</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1212-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1212-4)</PackageDescription>
<NDC11Code>36987-1212-04</NDC11Code>
<ProductNDC>36987-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flounder</ProprietaryName>
<NonProprietaryName>Flounder</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>FLOUNDER</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-1</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (68071-1212-1) </PackageDescription>
<NDC11Code>68071-1212-01</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-2</NDCCode>
<PackageDescription>270 CAPSULE in 1 BOTTLE (68071-1212-2) </PackageDescription>
<NDC11Code>68071-1212-02</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68071-1212-3) </PackageDescription>
<NDC11Code>68071-1212-03</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-4</NDCCode>
<PackageDescription>84 CAPSULE in 1 BOTTLE (68071-1212-4) </PackageDescription>
<NDC11Code>68071-1212-04</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-5</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE (68071-1212-5) </PackageDescription>
<NDC11Code>68071-1212-05</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-6</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (68071-1212-6) </PackageDescription>
<NDC11Code>68071-1212-06</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-7</NDCCode>
<PackageDescription>7 CAPSULE in 1 BOTTLE (68071-1212-7) </PackageDescription>
<NDC11Code>68071-1212-07</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-8</NDCCode>
<PackageDescription>180 CAPSULE in 1 BOTTLE (68071-1212-8) </PackageDescription>
<NDC11Code>68071-1212-08</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68071-1212-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (68071-1212-9) </PackageDescription>
<NDC11Code>68071-1212-09</NDC11Code>
<ProductNDC>68071-1212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Postherpetic neuralgia in adults ( 1) , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy ( 1) .</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl) cyclohexane acetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and a molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>53002-0060-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53002-0060-0) </PackageDescription>
<NDC11Code>53002-0060-00</NDC11Code>
<ProductNDC>53002-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201506</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital HerpesTreatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-infected patientsReduction of transmission, 3 Herpes Zoster.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride, USP is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pKas for valacyclovir hydrochloride, USP are 1.90, 7.47, and 9.43. Valacyclovir hydrochloride, USP comply with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-0061-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53002-0061-0) </PackageDescription>
<NDC11Code>53002-0061-00</NDC11Code>
<ProductNDC>53002-0061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090682</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) : 1 Cold Sores (Herpes Labialis) , 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1-infected patients Reduction of transmission , 3 Herpes Zoster .</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir.Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>53002-0062-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (53002-0062-0) </PackageDescription>
<NDC11Code>53002-0062-00</NDC11Code>
<ProductNDC>53002-0062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir</ProprietaryName>
<NonProprietaryName>Valacyclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203047</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir tablet, USP is a nucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients (1.1) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-infected patients Reduction of transmission Herpes Zoster Pediatric Patients (1.2) Cold Sores (Herpes Labialis) Chickenpox Limitations of Use (1.3) The efficacy and safety of valacyclovir tablets, USP have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride USP equivalent to 500 mg or 1gm valacyclovir and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. In addition to this 500 mg contains FD&C blue #2/ indigo carmine aluminum lake. The chemical name of valacyclovir hydrochloride is L-valine2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester hydrochloride monohydrate. It has the following structural formula:. Valacyclovir hydrochloride USP (monohydrate)is a white or almost white powder with the molecular formula C 13H 23N 6O 5Cl and a molecular weight of 378.81. Valacyclovir hydrochloride USP is freely soluble in water and practically insoluble in 1-octanol. The pka for valacyclovir hydrochloride is 5.95. Valacyclovir Tablets USP, 500 gm and 1 g complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>53002-0270-0</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (53002-0270-0) </PackageDescription>
<NDC11Code>53002-0270-00</NDC11Code>
<ProductNDC>53002-0270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203834</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration. Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&C blue lake # 2 Indigo carmine AL, respectively. Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225.20. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-. It has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>53002-0271-0</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (53002-0271-0) </PackageDescription>
<NDC11Code>53002-0271-00</NDC11Code>
<ProductNDC>53002-0271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075382</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets are formulations of an antiviral drug for oral administration. Each 800-mg tablet of acyclovir contains 800 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400 mg of acyclovir and the inactive ingredients corn starch, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C 8H 11N 5O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]; it has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>53002-0272-0</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (53002-0272-0) </PackageDescription>
<NDC11Code>53002-0272-00</NDC11Code>
<ProductNDC>53002-0272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209366</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir is indicated for the acute treatment of herpes zoster (shingles).</IndicationAndUsage>
<Description>Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Tablets are formulations for oral administration. Each 800-mg tablet of acyclovir contains 800mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino -1, 9 -dihydro -9 - [(2-hydroxyethoxy) methyl]-6 H-purin-6 -one; it has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>53002-0670-0</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (53002-0670-0) </PackageDescription>
<NDC11Code>53002-0670-00</NDC11Code>
<ProductNDC>53002-0670</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160429</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204446</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>