RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>66406-0460-9</NDCCode>
    <PackageDescription>30457 TABLET, FILM COATED in 1 DRUM (66406-0460-9) </PackageDescription>
    <NDC11Code>66406-0460-09</NDC11Code>
    <ProductNDC>66406-0460</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Acoramidis Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20250915</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>ACORAMIDIS HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>356</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-11-07</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>15-SEP-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>66406-0460-7</NDCCode>
    <PackageDescription>27264 TABLET, FILM COATED in 1 DRUM (66406-0460-7) </PackageDescription>
    <NDC11Code>66406-0460-07</NDC11Code>
    <ProductNDC>66406-0460</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Acoramidis Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20250915</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>ACORAMIDIS HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>356</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-11-07</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>15-SEP-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>66406-0039-9</NDCCode>
    <PackageDescription>6 BOTTLE in 1 CASE (66406-0039-9)  &gt; 30 CAPSULE in 1 BOTTLE</PackageDescription>
    <NDC11Code>66406-0039-09</NDC11Code>
    <ProductNDC>66406-0039</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>20100803</StartMarketingDate>
    <EndMarketingDate>20180328</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20180328</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>66406-0049-9</NDCCode>
    <PackageDescription>48 BOTTLE in 1 CASE (66406-0049-9)  &gt; 100 CAPSULE in 1 BOTTLE</PackageDescription>
    <NDC11Code>66406-0049-09</NDC11Code>
    <ProductNDC>66406-0049</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <StartMarketingDate>19700522</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Patheon Inc.</LabelerName>
    <SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0254-0460-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (0254-0460-01) </PackageDescription>
    <NDC11Code>00254-0460-01</NDC11Code>
    <ProductNDC>0254-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Colchicine</ProprietaryName>
    <NonProprietaryName>Colchicine</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208678</ApplicationNumber>
    <LabelerName>Par Health USA, LLC</LabelerName>
    <SubstanceName>COLCHICINE</SubstanceName>
    <StrengthNumber>.6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Alkaloid [EPC], Alkaloids [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Colchicine Capsules are indicated for prophylaxis of gout flares in adults. Limitations of use. The safety and effectiveness of colchicine for acute treatment of gout flares during prophylaxis has not been studied. Colchicine is not an analgesic medication and should not be used to treat pain from other causes.</IndicationAndUsage>
    <Description>Colchicine is an alkaloid obtained from the plant colchicum autumnale. The chemical name for colchicine is (S)-N-(5,6,7,9- tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen­7-yl) acetamide. The structural formula is represented below. Colchicine consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine is soluble in water, freely soluble in alcohol, and slightly soluble in ether. Colchicine Capsules are supplied for oral administration. Each capsule contains 0.6 mg Colchicine and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate. The capsule shell contains gelatin, D&amp;C YELLOW #10, FD&amp;C Blue #1, FDA/E172 BLACK IRON OXIDE, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0363-0862-12</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (0363-0862-12)  *  177 mL in 1 BOTTLE, PLASTIC (0363-0337-06)  *  177 mL in 1 BOTTLE, PLASTIC (0363-0460-06) </PackageDescription>
    <NDC11Code>00363-0862-12</NDC11Code>
    <ProductNDC>0363-0862</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Daytime Mucus Relief Severe Congestion And Cough And Nighttime Cold And Flu</ProprietaryName>
    <ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Acetaminophen, Diphenhydramine Hci</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20150731</StartMarketingDate>
    <EndMarketingDate>20261228</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M012</ApplicationNumber>
    <LabelerName>Walgreens</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150731</StartMarketingDatePackage>
    <EndMarketingDatePackage>20261228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nighttime: 1 temporarily relieves these common cold and flu symptoms , 2 cough , 3 nasal congestion , 4 minor aches and pains , 5 sore throat , 6 headache , 7 runny nose , 8 sneezing , 9 temporarily reduces fever , 10 controls cough to help you get to sleep.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0456-0460-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (0456-0460-01) </PackageDescription>
    <NDC11Code>00456-0460-01</NDC11Code>
    <ProductNDC>0456-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Armour Thyroid</ProprietaryName>
    <NonProprietaryName>Thyroid, Porcine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19960401</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>SUS SCROFA THYROID</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-09-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19960401</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Armour Thyroid (thyroid tablets, USP) are indicated. 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.</IndicationAndUsage>
    <Description>Armour Thyroid (thyroid tablets, USP)* for oral use is a desiccated thyroid extract that is derived from porcine thyroid glands. (T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis.) They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose, microcrystalline cellulose, sodium starch glycolate and opadry white. Armour Thyroid may have a strong, characteristic odor due to its thyroid extract component.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-0460-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0591-0460-01) </PackageDescription>
    <NDC11Code>00591-0460-01</NDC11Code>
    <ProductNDC>0591-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glipizide</ProprietaryName>
    <NonProprietaryName>Glipizide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19950227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074223</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>GLIPIZIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19950227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-0460-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (0591-0460-05) </PackageDescription>
    <NDC11Code>00591-0460-05</NDC11Code>
    <ProductNDC>0591-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glipizide</ProprietaryName>
    <NonProprietaryName>Glipizide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19950227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074223</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>GLIPIZIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19950227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>0591-0460-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0591-0460-10) </PackageDescription>
    <NDC11Code>00591-0460-10</NDC11Code>
    <ProductNDC>0591-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Glipizide</ProprietaryName>
    <NonProprietaryName>Glipizide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19950227</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074223</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>GLIPIZIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19950227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido) ethyl]phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below. Glipizide, USP is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Each tablet, for oral administration, contains 5 mg or 10 mg glipizide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide; croscarmellose sodium; lactose anhydrous; microcrystalline cellulose; pregelatinized starch 1500 (maize) and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>10122-460-02</NDCCode>
    <PackageDescription>1 CANISTER in 1 CARTON (10122-460-02)  / 120 AEROSOL, METERED in 1 CANISTER</PackageDescription>
    <NDC11Code>10122-0460-02</NDC11Code>
    <ProductNDC>10122-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trimbow</ProprietaryName>
    <NonProprietaryName>Beclomethasone Dipropionate/formoterol Fumarate/glycopyrrolate</NonProprietaryName>
    <DosageFormName>AEROSOL, METERED</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20260514</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219622</ApplicationNumber>
    <LabelerName>Chiesi USA, Inc.</LabelerName>
    <SubstanceName>BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE</SubstanceName>
    <StrengthNumber>86; 4.9; 10.6</StrengthNumber>
    <StrengthUnit>ug/1; ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260514</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>TRIMBOW is indicated for the maintenance treatment of asthma in adult patients aged 18 years and older. Limitations of Use. TRIMBOW is NOT indicated for relief of acute bronchospasm [see Warnings and Precautions (5.2)].</IndicationAndUsage>
    <Description>TRIMBOW (beclomethasone dipropionate, formoterol fumarate and glycopyrrolate) Inhalation Aerosol is a pressurized metered-dose inhaler that delivers a combination of beclomethasone dipropionate [an inhaled corticosteroid (ICS)], formoterol fumarate [an inhaled long-acting beta2-adrenergic agonist (a LABA)] and glycopyrrolate (an anticholinergic) for oral inhalation. Beclomethasone dipropionate, an inhaled corticosteroid [ICS], has the chemical name. [2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-chloro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate. Beclomethasone dipropionate is a white to creamy white, odorless powder, insoluble in water, freely soluble in acetone, and sparingly soluble in alcohol, with a molecular weight of 521.04218 g/mol, and the molecular formula is C28H37ClO7. The structural formula is as follows:. Formoterol fumarate, a long-acting β2 agonist has the chemical name (E)-but-2-enedioic acid; N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-formamide dihydrate. Formoterol fumarate is a powder that is slightly soluble in water. Formoterol fumarate  has a molecular weight of 840.91 g/mol, and the molecular formula is C42H52N4O12. The structural formula is as follows:. Formoterol fumarate contains two chiral centers and consists of a single enantiomeric pair (a racemate of R,R and S,S) . Glycopyrrolate is a quarternary ammonium bromide salt with the following chemical name: [RS-]-3-[(SR)-(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl-Pyrrolidinium bromide. Two asymmetric atoms of carbon are present in the molecule: Glycopyrronium bromide is represented by the (R,S)-(S,R) racemic pair of enantiomers, corresponding to the threo diastereoisomeric structure. Glycopyrrolate is a powder that is freely soluble in water. Glycopyrrolate has a molecular weight of 398.33 g/mol, and the molecular formula is C19H28BrNO3. The structural formula is as follows. Glycopyrrolate contains two chiral centers and is a racemate of a 1;1 mixture of the R,S and S,R diastereomers. The active moiety, glycopyrronium, is the positively charged ion of glycopyrrolate. TRIMBOW 86 mcg/4.9 mcg/10.6 mcg and TRIMBOW 172 mcg/4.9 mcg/10.6 mcg are formulated as a hydrofluoroalkane (HFA 134a) propelled pressurized, metered-dose inhalers, each containing 120 actuations.  The canister is supplied with a grey plastic actuator with an integrated dose counter mechanism and mouthpiece, and a red cap (TRIMBOW 86 mcg/4.9 mcg/10.6 mcg) or a green cap (TRIMBOW 172 mcg/4.9 mcg/10.6 mcg). As a solution, TRIMBOW does not need to be shaken before use. TRIMBOW should be “primed” by actuating 2 times prior to using the first dose from a new canister. If the inhaler has not been used for 30 days or longer, re-prime the inhaler [see How Supplied/Storage and Handling (16)]. After priming, each actuation meters 100 or 200 mcg of beclomethasone dipropionate, 6.0 mcg of formoterol fumarate (equivalent to 5.7 mcg of formoterol fumarate anhydrous), and 12.5 mcg of glycopyrrolate (equivalent to 10 mcg of glycopyrronium) in 73.8 mg of solution from the valve and delivers 86 or 172 mcg of beclomethasone dipropionate, 4.9 mcg of formoterol fumarate (equivalent to 4.2 mcg of formoterol fumarate anhydrous), and 10.6 mcg of glycopyrrolate (equivalent to 8.5 mcg of glycopyrronium) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as coordination of the device (metered dose inhaler [MDI]) actuation with the inhalation maneuver, inspiratory flow and peak inspiratory flow through the delivery system, which may vary in patients with asthma and other pulmonary diseases and conditions. Avoid spraying in the eyes or face while using TRIMBOW. TRIMBOW contains dehydrated alcohol (18% v/v), HFA 134a, and hydrochloric acid as excipients in the formulation.</Description>
  </NDC>
  <NDC>
    <NDCCode>30698-460-01</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (30698-460-01) </PackageDescription>
    <NDC11Code>30698-0460-01</NDC11Code>
    <ProductNDC>30698-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lopressor</ProprietaryName>
    <NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250811</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218698</ApplicationNumber>
    <LabelerName>VALIDUS PHARMACEUTICALS LLC</LabelerName>
    <SubstanceName>METOPROLOL TARTRATE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>LOPRESSOR tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&amp;C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>30698-460-03</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (30698-460-03) </PackageDescription>
    <NDC11Code>30698-0460-03</NDC11Code>
    <ProductNDC>30698-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lopressor</ProprietaryName>
    <NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250811</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218698</ApplicationNumber>
    <LabelerName>VALIDUS PHARMACEUTICALS LLC</LabelerName>
    <SubstanceName>METOPROLOL TARTRATE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>LOPRESSOR tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&amp;C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>30698-460-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (30698-460-10) </PackageDescription>
    <NDC11Code>30698-0460-10</NDC11Code>
    <ProductNDC>30698-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lopressor</ProprietaryName>
    <NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250811</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218698</ApplicationNumber>
    <LabelerName>VALIDUS PHARMACEUTICALS LLC</LabelerName>
    <SubstanceName>METOPROLOL TARTRATE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250811</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>LOPRESSOR tablets contain metoprolol tartrate, a beta-adrenergic blocker. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82 g/mol. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. LOPRESSOR is available as 12.5 mg tablets for oral administration containing 12.5 mg metoprolol tartrate (equivalent to 9.76 mg of metoprolol). Inactive Ingredients: Tablets contain colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. Film coating contains D&amp;C Red 30, hypromellose, polyethylene glycol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>39822-0460-2</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (39822-0460-2)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
    <NDC11Code>39822-0460-02</NDC11Code>
    <ProductNDC>39822-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20251215</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215324</ApplicationNumber>
    <LabelerName>XGen Pharmaceuticals DJB, Inc.</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.25</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Vancomycin hydrochloride for injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride, USP is (S a)- (3 S,6 R,7 R,22 R,23 S,26 S,36 R,38a R)-44-[[2- O-(3-Amino-2,3,6-trideoxy-3- C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro- 2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2 R)-4- methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22 H-8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1 H,16 H-[l,6,9]oxadiazacyclohexadecino[4,5- m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66H 75Cl 2N 9O 24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula:. Vancomycin hydrochloride for injection, USP is a sterile off-white to light tan colored lyophilized plug or powder for injection. Vancomycin hydrochloride for injection, USP is supplied in single-dose vials, containing 1.28 g or 1.54 g of vancomycin hydrochloride, USP equivalent to 1.25 g or 1.5 g of vancomycin base. The lyophilized powder is reconstituted with sterile water for injection, USP which forms a clear, colorless or light to dark tan solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5)].</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-460-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42291-460-30) </PackageDescription>
    <NDC11Code>42291-0460-30</NDC11Code>
    <ProductNDC>42291-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cinacalcet</ProprietaryName>
    <NonProprietaryName>Cinacalcet</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210727</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206125</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (  1.1)  .</IndicationAndUsage>
    <Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C 22H 22F 3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula:  Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: colloidal silicon dioxide, crospovidone, FD&amp;C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-460-82</NDCCode>
    <PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (42571-460-82) </PackageDescription>
    <NDC11Code>42571-0460-82</NDC11Code>
    <ProductNDC>42571-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varenicline Tartrate</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218302</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>VARENICLINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking-cessation treatment.</IndicationAndUsage>
    <Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6 H-pyrazino[2,3- h][3]benzazepine, (2 R,3 R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C 13H 13N 3 C 4H 6O 6. The chemical structure is:. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg oval shaped, biconvex, white to off-white, film-coated tablet debossed with "0.5" on one side and plain on the other side and a 1 mg oval shaped, biconvex, light blue film-coated tablet debossed with "1" on one side and plain on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium and stearic acid. In addition, the 0.5 mg tablets are coated with the Opadry® White which contains  hypromellose, polyethylene glycol and titanium dioxide, and 1 mg tablets are coated with Opadry ®Blue which contain hypromellose, polyethylene glycol, titanium dioxide and FD&amp;C blue #2.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-460-88</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (42571-460-88)  / 56 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>42571-0460-88</NDC11Code>
    <ProductNDC>42571-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Varenicline Tartrate</ProprietaryName>
    <NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218302</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>VARENICLINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking-cessation treatment.</IndicationAndUsage>
    <Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6 H-pyrazino[2,3- h][3]benzazepine, (2 R,3 R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C 13H 13N 3 C 4H 6O 6. The chemical structure is:. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg oval shaped, biconvex, white to off-white, film-coated tablet debossed with "0.5" on one side and plain on the other side and a 1 mg oval shaped, biconvex, light blue film-coated tablet debossed with "1" on one side and plain on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium and stearic acid. In addition, the 0.5 mg tablets are coated with the Opadry® White which contains  hypromellose, polyethylene glycol and titanium dioxide, and 1 mg tablets are coated with Opadry ®Blue which contain hypromellose, polyethylene glycol, titanium dioxide and FD&amp;C blue #2.</Description>
  </NDC>
  <NDC>
    <NDCCode>43602-460-10</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (43602-460-10) </PackageDescription>
    <NDC11Code>43602-0460-10</NDC11Code>
    <ProductNDC>43602-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210826</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215414</ApplicationNumber>
    <LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210826</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate tablets are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch, hypromellose, sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol. The 25 mg strength also contains polysorbate. The 50 mg strength also contains polysorbate, iron oxide yellow and iron oxide red. The 100 mg strength also contains polysorbate and iron oxide yellow. The 200 mg strength also contains iron oxide red. FDA approved tests Assay and related compounds differ from USP. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>43602-460-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (43602-460-30) </PackageDescription>
    <NDC11Code>43602-0460-30</NDC11Code>
    <ProductNDC>43602-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210826</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215414</ApplicationNumber>
    <LabelerName>Ascent Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210826</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate tablets are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch, hypromellose, sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol. The 25 mg strength also contains polysorbate. The 50 mg strength also contains polysorbate, iron oxide yellow and iron oxide red. The 100 mg strength also contains polysorbate and iron oxide yellow. The 200 mg strength also contains iron oxide red. FDA approved tests Assay and related compounds differ from USP. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0460-1</NDCCode>
    <PackageDescription>2 mL in 1 VIAL, MULTI-DOSE (49288-0460-1)</PackageDescription>
    <NDC11Code>49288-0460-01</NDC11Code>
    <ProductNDC>49288-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sorrel Mixture</ProprietaryName>
    <NonProprietaryName>Sorrel Mixture</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>RUMEX OBTUSIFOLIUS POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX ALTISSIMUS POLLEN; RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN; RUMEX CRISPUS POLLEN</SubstanceName>
    <StrengthNumber>.004; .004; .004; .004; .004</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Increased Histamine Release [PE],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0460-2</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49288-0460-2)</PackageDescription>
    <NDC11Code>49288-0460-02</NDC11Code>
    <ProductNDC>49288-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sorrel Mixture</ProprietaryName>
    <NonProprietaryName>Sorrel Mixture</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>RUMEX OBTUSIFOLIUS POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX ALTISSIMUS POLLEN; RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN; RUMEX CRISPUS POLLEN</SubstanceName>
    <StrengthNumber>.004; .004; .004; .004; .004</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Increased Histamine Release [PE],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0460-3</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0460-3)</PackageDescription>
    <NDC11Code>49288-0460-03</NDC11Code>
    <ProductNDC>49288-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sorrel Mixture</ProprietaryName>
    <NonProprietaryName>Sorrel Mixture</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>RUMEX OBTUSIFOLIUS POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX ALTISSIMUS POLLEN; RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN; RUMEX CRISPUS POLLEN</SubstanceName>
    <StrengthNumber>.004; .004; .004; .004; .004</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Increased Histamine Release [PE],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0460-4</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0460-4)</PackageDescription>
    <NDC11Code>49288-0460-04</NDC11Code>
    <ProductNDC>49288-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sorrel Mixture</ProprietaryName>
    <NonProprietaryName>Sorrel Mixture</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>RUMEX OBTUSIFOLIUS POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX ALTISSIMUS POLLEN; RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN; RUMEX CRISPUS POLLEN</SubstanceName>
    <StrengthNumber>.004; .004; .004; .004; .004</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Increased Histamine Release [PE],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0460-5</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0460-5)</PackageDescription>
    <NDC11Code>49288-0460-05</NDC11Code>
    <ProductNDC>49288-0460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sorrel Mixture</ProprietaryName>
    <NonProprietaryName>Sorrel Mixture</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19740323</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102223</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>RUMEX OBTUSIFOLIUS POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX ALTISSIMUS POLLEN; RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN; RUMEX CRISPUS POLLEN</SubstanceName>
    <StrengthNumber>.004; .004; .004; .004; .004</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL; g/mL; g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Increased Histamine Release [PE],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
    <Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
  </NDC>
  <NDC>
    <NDCCode>57955-0460-2</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (57955-0460-2)  &gt; 59 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>57955-0460-02</NDC11Code>
    <ProductNDC>57955-0460</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kids Tummy Aches</ProprietaryName>
    <NonProprietaryName>Argentum Nitricum, Bryonia, Cocculus Indicus, Glonoinum, Lac Defloratum, Petroleum, Staphysagria, Tabacum</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180322</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>King Bio Inc</LabelerName>
    <SubstanceName>SILVER NITRATE; BRYONIA ALBA ROOT; ANAMIRTA COCCULUS SEED; NITROGLYCERIN; SKIM MILK; KEROSENE; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF</SubstanceName>
    <StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
    <StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for temporary relief of symptoms: 1 nausea, 2 vomiting, 3 belching, 4 gas, 5 bloating, 6 aversion to food, 7 stomach cramps, 8 headaches, 9 empty feeling in stomach.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59651-460-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (59651-460-60) </PackageDescription>
    <NDC11Code>59651-0460-60</NDC11Code>
    <ProductNDC>59651-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tofacitinib</ProprietaryName>
    <NonProprietaryName>Tofacitinib</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215356</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>TOFACITINIB CITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tofacitinib tablets are Janus kinase (JAK) inhibitors. Tofacitinib tablets are indicated for the treatment of adult patients with:.  Tofacitinib tablets are indicated for the treatment of pediatric patients 2 years of age and older with. Limitations of Use.</IndicationAndUsage>
    <Description>Tofacitinib tablets are formulated with the citrate salt of tofacitinib, a JAK inhibitor. Tofacitinib citrate is a white to off-white crystalline powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1). The solubility of tofacitinib citrate in water is 2.9 mg/mL. Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6OC6H8O7. The chemical structure of tofacitinib citrate is. Tofacitinib tablets are supplied for oral administration as a 5 mg white to off-white, round, biconvex, film-coated tablets debossed with “TI” on one side and “5” on other side. Each tablet contains 5 mg tofacitinib (equivalent to 8.075 mg tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and triacetin. Tofacitinib tablets are supplied for oral administration as a 10 mg blue, round, biconvex, film-coated tablets debossed with “TI” on one side and “10” on other side. Each tablet contains 10 mg tofacitinib (equivalent to 16.150 mg of tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, FD&amp;C blue #1, FD&amp;C blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>63868-460-12</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (63868-460-12)  &gt; 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>63868-0460-12</NDC11Code>
    <ProductNDC>63868-460</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nighttime Maximum Strength Cold And Flu</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, Dextromethorphan Hydrobromide</NonProprietaryName>
    <DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160803</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Chain Drug Marketing Association Inc.</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 10; 6.25; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160803</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 nasal congestion, 2 sinus congestion &amp; pressure, 3 cough due to minor throat &amp; bronchial irritation, 4 cough to help you sleep, 5 minor aches &amp; pains, 6 headache, 7 fever, 8 sore throat, 9 runny nose &amp; sneezing, 10 reduces swelling of nasal passages, 11 temporarily restores freer breathing through the nose, 12 promotes nasal and/or sinus drainage.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65862-460-49</NDCCode>
    <PackageDescription>4000 TABLET, FILM COATED in 1 BOTTLE (65862-460-49) </PackageDescription>
    <NDC11Code>65862-0460-49</NDC11Code>
    <ProductNDC>65862-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Galantamine</ProprietaryName>
    <NonProprietaryName>Galantamine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090957</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.</IndicationAndUsage>
    <Description>Galantamine tablets, USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white or almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is: Galantamine tablets, USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126 mg, 10.252 mg, and 15.378 mg of galantamine hydrobromide USP, respectively. Inactive ingredients include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), propylene glycol, talc, and titanium dioxide. The 4 mg tablets contain iron oxide yellow. The 8 mg tablets contain iron oxide red. The 12 mg tablets contain iron oxide red and FD&amp;C yellow #6 aluminum lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-460-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (65862-460-60) </PackageDescription>
    <NDC11Code>65862-0460-60</NDC11Code>
    <ProductNDC>65862-460</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Galantamine</ProprietaryName>
    <NonProprietaryName>Galantamine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090957</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.</IndicationAndUsage>
    <Description>Galantamine tablets, USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white or almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is: Galantamine tablets, USP contain 4 mg, 8 mg, and 12 mg galantamine as 5.126 mg, 10.252 mg, and 15.378 mg of galantamine hydrobromide USP, respectively. Inactive ingredients include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), propylene glycol, talc, and titanium dioxide. The 4 mg tablets contain iron oxide yellow. The 8 mg tablets contain iron oxide red. The 12 mg tablets contain iron oxide red and FD&amp;C yellow #6 aluminum lake.</Description>
  </NDC>
</NDCList>