{
"NDC": [
{
"NDCCode": "43598-977-05",
"PackageDescription": "1 TUBE in 1 CARTON (43598-977-05) / 50 g in 1 TUBE",
"NDC11Code": "43598-0977-05",
"ProductNDC": "43598-977",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium Topical Gel, 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210986",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210131",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
},
{
"NDCCode": "43598-977-10",
"PackageDescription": "1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE",
"NDC11Code": "43598-0977-10",
"ProductNDC": "43598-977",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium Topical Gel, 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210986",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200914",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
},
{
"NDCCode": "43598-977-15",
"PackageDescription": "1 TUBE in 1 CARTON (43598-977-15) / 150 g in 1 TUBE",
"NDC11Code": "43598-0977-15",
"ProductNDC": "43598-977",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium Topical Gel, 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210986",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210131",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
},
{
"NDCCode": "43598-977-21",
"PackageDescription": "2 TUBE in 1 CARTON (43598-977-21) / 100 g in 1 TUBE",
"NDC11Code": "43598-0977-21",
"ProductNDC": "43598-977",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium Topical Gel, 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210986",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250505",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
},
{
"NDCCode": "43598-977-22",
"PackageDescription": "1 TUBE in 1 CARTON (43598-977-22) / 20 g in 1 TUBE",
"NDC11Code": "43598-0977-22",
"ProductNDC": "43598-977",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium Topical Gel, 1%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210986",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210331",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use."
},
{
"NDCCode": "59088-224-00",
"PackageDescription": "1 KIT in 1 KIT (59088-224-00) * 1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE",
"NDC11Code": "59088-0224-00",
"ProductNDC": "59088-224",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venngel Ii",
"NonProprietaryName": "Diclofenac Sodium, Isopropyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20250220",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250220",
"SamplePackage": "N",
"Description": "Diclofenac sodium topical gel, 1% w/w is a non-steroidal anti-inflammatory drug (NSAID) for topical use only. It contains the active ingredient, diclofenac sodium, USP, in an opaque, white to off-white gel base. Diclofenac sodium, USP is a white to off-white crystalline powder. Diclofenac sodium, USP is a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C 14H 10Cl 2NNaO 2. It has the following structural formula:. Diclofenac sodium topical gel, 1% also contains carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution."
},
{
"NDCCode": "59088-806-00",
"PackageDescription": "1 KIT in 1 KIT (59088-806-00) * 85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07) * 1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE",
"NDC11Code": "59088-0806-00",
"ProductNDC": "59088-806",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclolidol Kit",
"NonProprietaryName": "Lidocaine Hcl, Diclofenac Sodium",
"DosageFormName": "KIT",
"StartMarketingDate": "20250909",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2025-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250909",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of arthritis pain ONLY in the following areas: 1 hand, wrist, elbow (upper body areas), 2 foot, ankle, knee (lower body areas)."
},
{
"NDCCode": "42385-977-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-05) ",
"NDC11Code": "42385-0977-05",
"ProductNDC": "42385-977",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20231006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217631",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231006",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethyl imidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white or almost white crystals with a molecular formula of C4H11N5HCl and a molecular weight of 165.62. It is freely soluble in water, slightly soluble in 96% ethanol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, hypromellose, and magnesium stearate. Metformin Hydrochloride Extended-Release Tablets, USP meets USP Dissolution Test 11."
},
{
"NDCCode": "55648-977-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (55648-977-04) > 10 TABLET in 1 BLISTER PACK (55648-977-05)",
"NDC11Code": "55648-0977-04",
"ProductNDC": "55648-977",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078038",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "57297-977-05",
"PackageDescription": "1 BAG in 1 DRUM (57297-977-05) / 50 kg in 1 BAG",
"NDC11Code": "57297-0977-05",
"ProductNDC": "57297-977",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20191205",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-01-18",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "05-DEC-19"
},
{
"NDCCode": "59651-977-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (59651-977-05) ",
"NDC11Code": "59651-0977-05",
"ProductNDC": "59651-977",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077859",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250327",
"SamplePackage": "N",
"IndicationAndUsage": "Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).",
"Description": "Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are ascorbic acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "64679-977-04",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-977-04) > 10 TABLET in 1 BLISTER PACK (64679-977-05)",
"NDC11Code": "64679-0977-04",
"ProductNDC": "64679-977",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078038",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "68196-977-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (68196-977-05) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "68196-0977-05",
"ProductNDC": "68196-977",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171016",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209339",
"LabelerName": "Sam's West Inc",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171016",
"SamplePackage": "N"
},
{
"NDCCode": "68428-977-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-977-05)",
"NDC11Code": "68428-0977-05",
"ProductNDC": "68428-977",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lonicera Periclymenum",
"NonProprietaryName": "Lonicera Periclymenum Flowering Twig",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "LONICERA PERICLYMENUM FLOWERING TWIG",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Indications. LONICERA PER Irritability."
},
{
"NDCCode": "43598-002-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-05) ",
"NDC11Code": "43598-0002-05",
"ProductNDC": "43598-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240909",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078421",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240909",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP."
},
{
"NDCCode": "43598-052-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-052-05) ",
"NDC11Code": "43598-0052-05",
"ProductNDC": "43598-052",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen 250 Mg And Ibuprofen 125 Mg",
"NonProprietaryName": "Acetaminophen And Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218247",
"LabelerName": "Dr. Reddy's Labortories Inc",
"SubstanceName": "IBUPROFEN; ACETAMINOPHEN",
"StrengthNumber": "125; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250219",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 temporarily relieves minor aches and pains due to:headache toothachebackachemenstrual crampsmuscular achesminor pain of arthritis."
},
{
"NDCCode": "43598-096-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43598-096-05) ",
"NDC11Code": "43598-0096-05",
"ProductNDC": "43598-096",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Javygtor",
"NonProprietaryName": "Sapropterin Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207685",
"LabelerName": "Dr. Reddys Laboratories Inc",
"SubstanceName": "SAPROPTERIN DIHYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221003",
"SamplePackage": "N",
"IndicationAndUsage": "JAVYGTOR (sapropterin dihydrochloride) is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). JAVYGTOR is to be used in conjunction with a Phe-restricted diet.",
"Description": "JAVYGTOR (sapropterin dihydrochloride) is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in JAVYGTOR, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is a white crystalline powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2- dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C9H15N5O3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. JAVYGTOR is supplied as tablets contains 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Tablets are off-white to light yellow, mottled, round uncoated tablet debossed with ‘|’ on one side and plain on other side. Each tablet contains the following inactive ingredients: ascorbic acid, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, mannitol, riboflavin and sodium stearyl fumarate."
},
{
"NDCCode": "43598-098-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43598-098-05) ",
"NDC11Code": "43598-0098-05",
"ProductNDC": "43598-098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-099-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43598-099-05) ",
"NDC11Code": "43598-0099-05",
"ProductNDC": "43598-099",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-101-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43598-101-05) ",
"NDC11Code": "43598-0101-05",
"ProductNDC": "43598-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-103-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (43598-103-05) ",
"NDC11Code": "43598-0103-05",
"ProductNDC": "43598-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214659",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "43598-121-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-121-05) ",
"NDC11Code": "43598-0121-05",
"ProductNDC": "43598-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091023",
"LabelerName": "Dr.Reddy's Laboratories Inc",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250415",
"SamplePackage": "N",
"Description": "Clopidogrel tablets USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate USP is C16H16Cl NO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate USP is a white to off-white powder. It is freely soluble in methanol and practically insoluble in ether. It has a specific optical rotation of between +53° and + 58°. Clopidogrel for oral administration is provided as pink, round, biconvex, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent to 75 mg of clopidogrel base or pink, oval, film-coated tablets containing 391.5 mg of clopidogrel bisulfate USP which is the molar equivalent to 300 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate as inactive ingredients. The film-coating contains hypromellose 2910, iron oxide red, polyethylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "43598-122-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-122-05) ",
"NDC11Code": "43598-0122-05",
"ProductNDC": "43598-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel Bisulfate",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091023",
"LabelerName": "Dr.Reddy's Laboratories Inc",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250415",
"SamplePackage": "N",
"Description": "Clopidogrel tablets USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate USP is C16H16Cl NO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate USP is a white to off-white powder. It is freely soluble in methanol and practically insoluble in ether. It has a specific optical rotation of between +53° and + 58°. Clopidogrel for oral administration is provided as pink, round, biconvex, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent to 75 mg of clopidogrel base or pink, oval, film-coated tablets containing 391.5 mg of clopidogrel bisulfate USP which is the molar equivalent to 300 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate as inactive ingredients. The film-coating contains hypromellose 2910, iron oxide red, polyethylene glycol, talc and titanium dioxide."
},
{
"NDCCode": "43598-131-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-131-05) ",
"NDC11Code": "43598-0131-05",
"ProductNDC": "43598-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210441",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221024",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine Sulfate Tablets are an antimalarial and antirheumatic indicated for the. Limitations of Use (1.1): Hydroxychloroquine Sulfate Tablets are not recommended for the.",
"Description": "Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. The chemical name for hydroxychloroquine sulfate is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1). Its structural formula is. The molecular weight of hydroxychloroquine sulfate is 433.95, and molecular formula is C18H26CIN3OH2SO4. Hydroxychloroquine Sulfate Tablets, USP contains 100 mg hydroxychloroquine sulfate, equivalent to 77.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contains 300 mg hydroxychloroquine sulfate, equivalent to 232.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide. Hydroxychloroquine Sulfate Tablets, USP contain 400 mg hydroxychloroquine sulfate, equivalent to 310 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Meets USP Dissolution Test 1."
},
{
"NDCCode": "43598-132-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-132-05) ",
"NDC11Code": "43598-0132-05",
"ProductNDC": "43598-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210441",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221024",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine Sulfate Tablets are an antimalarial and antirheumatic indicated for the. Limitations of Use (1.1): Hydroxychloroquine Sulfate Tablets are not recommended for the.",
"Description": "Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. The chemical name for hydroxychloroquine sulfate is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1). Its structural formula is. The molecular weight of hydroxychloroquine sulfate is 433.95, and molecular formula is C18H26CIN3OH2SO4. Hydroxychloroquine Sulfate Tablets, USP contains 100 mg hydroxychloroquine sulfate, equivalent to 77.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contains 300 mg hydroxychloroquine sulfate, equivalent to 232.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide. Hydroxychloroquine Sulfate Tablets, USP contain 400 mg hydroxychloroquine sulfate, equivalent to 310 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Meets USP Dissolution Test 1."
},
{
"NDCCode": "43598-133-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-133-05) ",
"NDC11Code": "43598-0133-05",
"ProductNDC": "43598-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20221024",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210441",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221024",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine Sulfate Tablets are an antimalarial and antirheumatic indicated for the. Limitations of Use (1.1): Hydroxychloroquine Sulfate Tablets are not recommended for the.",
"Description": "Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. The chemical name for hydroxychloroquine sulfate is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1). Its structural formula is. The molecular weight of hydroxychloroquine sulfate is 433.95, and molecular formula is C18H26CIN3OH2SO4. Hydroxychloroquine Sulfate Tablets, USP contains 100 mg hydroxychloroquine sulfate, equivalent to 77.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contains 300 mg hydroxychloroquine sulfate, equivalent to 232.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide. Hydroxychloroquine Sulfate Tablets, USP contain 400 mg hydroxychloroquine sulfate, equivalent to 310 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Meets USP Dissolution Test 1."
},
{
"NDCCode": "43598-164-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-164-05) ",
"NDC11Code": "43598-0164-05",
"ProductNDC": "43598-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-165-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-165-05) ",
"NDC11Code": "43598-0165-05",
"ProductNDC": "43598-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-166-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (43598-166-05) ",
"NDC11Code": "43598-0166-05",
"ProductNDC": "43598-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076255",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131210",
"SamplePackage": "N",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2."
},
{
"NDCCode": "43598-172-15",
"PackageDescription": "10 AMPULE in 1 CARTON (43598-172-15) / 5 mL in 1 AMPULE (43598-172-05) ",
"NDC11Code": "43598-0172-15",
"ProductNDC": "43598-172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Biorphen",
"NonProprietaryName": "Phenylephrine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20221125",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212909",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221125",
"SamplePackage": "N",
"IndicationAndUsage": "BIORPHEN is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.",
"Description": "Phenylephrine is an alpha-1 adrenergic receptor agonist. The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α-[(methylamino) methyl] benzyl alcohol hydrochloride, its molecular formula is C9H13NO2· HCl (Molecular Weight: 203.67g/mol). Its structural formula is depicted below. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. BIORPHEN Injection, 500 mcg/5 mL (100 mcg/mL). BIORPHEN (phenylephrine hydrochloride) injection, 500 mcg/5 mL (100 mcg/mL),, is a sterile, nonpyrogenic, clear and colorless solution for intravenous use. It MUST NOT BE DILUTED before administration as an intravenous bolus. Each mL contains: phenylephrine hydrochloride 100 mcg (equivalent to 80 mcg of phenylephrine base), sodium chloride 9.0 mg in water for injection. The pH is adjusted with hydrochloric acid if necessary. The pH range is 3.0 to 5.0. BIORPHEN Injection, 10 mg/mL. BIORPHEN (phenylephrine hydrochloride) injection, 10 mg/mL, is a sterile, nonpyrogenic, clear and colorless solution for intravenous use. It MUST BE DILUTED before administration as an intravenous bolus or continuous intravenous infusion. Each mL contains: phenylephrine hydrochloride 10 mg (equivalent to 8.2 mg of phenylephrine base), sodium chloride 6.0 mg in water for injection. The pH is adjusted with hydrochloric acid if necessary. The pH range is 3.0 to 5.0."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>43598-977-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (43598-977-05) / 50 g in 1 TUBE</PackageDescription>
<NDC11Code>43598-0977-05</NDC11Code>
<ProductNDC>43598-977</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210986</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-977-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>43598-0977-10</NDC11Code>
<ProductNDC>43598-977</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210986</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-977-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (43598-977-15) / 150 g in 1 TUBE</PackageDescription>
<NDC11Code>43598-0977-15</NDC11Code>
<ProductNDC>43598-977</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210986</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-977-21</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (43598-977-21) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>43598-0977-21</NDC11Code>
<ProductNDC>43598-977</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210986</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-977-22</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (43598-977-22) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>43598-0977-22</NDC11Code>
<ProductNDC>43598-977</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200914</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210986</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-224-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-224-00) * 1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0224-00</NDC11Code>
<ProductNDC>59088-224</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venngel Ii</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium, Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250220</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Diclofenac sodium topical gel, 1% w/w is a non-steroidal anti-inflammatory drug (NSAID) for topical use only. It contains the active ingredient, diclofenac sodium, USP, in an opaque, white to off-white gel base. Diclofenac sodium, USP is a white to off-white crystalline powder. Diclofenac sodium, USP is a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C 14H 10Cl 2NNaO 2. It has the following structural formula:. Diclofenac sodium topical gel, 1% also contains carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>59088-806-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-806-00) * 85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07) * 1 TUBE in 1 CARTON (43598-977-10) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0806-00</NDC11Code>
<ProductNDC>59088-806</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclolidol Kit</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl, Diclofenac Sodium</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250909</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of arthritis pain ONLY in the following areas: 1 hand, wrist, elbow (upper body areas), 2 foot, ankle, knee (lower body areas).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42385-977-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-05) </PackageDescription>
<NDC11Code>42385-0977-05</NDC11Code>
<ProductNDC>42385-977</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217631</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethyl imidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white or almost white crystals with a molecular formula of C4H11N5HCl and a molecular weight of 165.62. It is freely soluble in water, slightly soluble in 96% ethanol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, hypromellose, and magnesium stearate. Metformin Hydrochloride Extended-Release Tablets, USP meets USP Dissolution Test 11.</Description>
</NDC>
<NDC>
<NDCCode>55648-977-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (55648-977-04) > 10 TABLET in 1 BLISTER PACK (55648-977-05)</PackageDescription>
<NDC11Code>55648-0977-04</NDC11Code>
<ProductNDC>55648-977</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078038</ApplicationNumber>
<LabelerName>Wockhardt Limited</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57297-977-05</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (57297-977-05) / 50 kg in 1 BAG</PackageDescription>
<NDC11Code>57297-0977-05</NDC11Code>
<ProductNDC>57297-977</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20191205</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-01-18</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-DEC-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59651-977-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (59651-977-05) </PackageDescription>
<NDC11Code>59651-0977-05</NDC11Code>
<ProductNDC>59651-977</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077859</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1 Skin and Skin Structure Infections (1.1), 2 Bone and Joint Infections (1.2), 3 Complicated Intra-Abdominal Infections (1.3), 4 Infectious Diarrhea (1.4), 5 Typhoid Fever (Enteric Fever) (1.5), 6 Uncomplicated Cervical and Urethral Gonorrhea (1.6), 7 Inhalational Anthrax post-exposure in adult and pediatric patients (1.7), 8 Plague in adult and pediatric patients (1.8), 9 Chronic Bacterial Prostatitis (1.9), 10 Lower Respiratory Tract Infections (1.10)Acute Exacerbation of Chronic Bronchitis, 11 Urinary Tract Infections (1.11)Urinary Tract Infections (UTI)Acute Uncomplicated CystitisComplicated UTI and Pyelonephritis in Pediatric Patients, 12 Acute Sinusitis (1.12).</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Each ciprofloxacin film-coated tablet contains 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets, USP are white to off-white. The inactive ingredients are ascorbic acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>64679-977-04</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (64679-977-04) > 10 TABLET in 1 BLISTER PACK (64679-977-05)</PackageDescription>
<NDC11Code>64679-0977-04</NDC11Code>
<ProductNDC>64679-977</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078038</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68196-977-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68196-977-05) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>68196-0977-05</NDC11Code>
<ProductNDC>68196-977</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171016</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209339</ApplicationNumber>
<LabelerName>Sam's West Inc</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM DIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-977-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-977-05)</PackageDescription>
<NDC11Code>68428-0977-05</NDC11Code>
<ProductNDC>68428-977</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lonicera Periclymenum</ProprietaryName>
<NonProprietaryName>Lonicera Periclymenum Flowering Twig</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130129</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>LONICERA PERICLYMENUM FLOWERING TWIG</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications. LONICERA PER Irritability.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-002-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-002-05) </PackageDescription>
<NDC11Code>43598-0002-05</NDC11Code>
<ProductNDC>43598-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240909</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078421</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules areindicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies(14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies(14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated as 1–[(1RS)-2-(Dimethylamino)-1-(4-Methoxy phenyl) ethyl] cyclohexanol hydrochloride and has the empirical formula of C17H28ClNO2. Its molecular weight is 313.9. The structural formula is shown as follows:. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol and water. Its partition coefficient is 0.1. Drug release is controlled by diffusion through the coating membrane on the Spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, ferric oxide red, gelatin, hypromellose, methyl alcohol, methylene chloride, microcrystalline cellulose, talc and titanium dioxide. In addition to the above 37.5mg consists of ferric oxide black and ferric oxide yellow. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are butyl alcohol, dehydrated alcohol, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Dissolution Test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>43598-052-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-052-05) </PackageDescription>
<NDC11Code>43598-0052-05</NDC11Code>
<ProductNDC>43598-052</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen 250 Mg And Ibuprofen 125 Mg</ProprietaryName>
<NonProprietaryName>Acetaminophen And Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218247</ApplicationNumber>
<LabelerName>Dr. Reddy's Labortories Inc</LabelerName>
<SubstanceName>IBUPROFEN; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>125; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 temporarily relieves minor aches and pains due to:headache toothachebackachemenstrual crampsmuscular achesminor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43598-096-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43598-096-05) </PackageDescription>
<NDC11Code>43598-0096-05</NDC11Code>
<ProductNDC>43598-096</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Javygtor</ProprietaryName>
<NonProprietaryName>Sapropterin Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207685</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Inc</LabelerName>
<SubstanceName>SAPROPTERIN DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JAVYGTOR (sapropterin dihydrochloride) is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). JAVYGTOR is to be used in conjunction with a Phe-restricted diet.</IndicationAndUsage>
<Description>JAVYGTOR (sapropterin dihydrochloride) is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in JAVYGTOR, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is a white crystalline powder. The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2- dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C9H15N5O3·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula. JAVYGTOR is supplied as tablets contains 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Tablets are off-white to light yellow, mottled, round uncoated tablet debossed with ‘|’ on one side and plain on other side. Each tablet contains the following inactive ingredients: ascorbic acid, colloidal silicon dioxide, crospovidone, low substituted hydroxypropyl cellulose, mannitol, riboflavin and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>43598-098-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43598-098-05) </PackageDescription>
<NDC11Code>43598-0098-05</NDC11Code>
<ProductNDC>43598-098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214659</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>43598-099-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43598-099-05) </PackageDescription>
<NDC11Code>43598-0099-05</NDC11Code>
<ProductNDC>43598-099</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214659</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>43598-101-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43598-101-05) </PackageDescription>
<NDC11Code>43598-0101-05</NDC11Code>
<ProductNDC>43598-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214659</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>43598-103-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (43598-103-05) </PackageDescription>
<NDC11Code>43598-0103-05</NDC11Code>
<ProductNDC>43598-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214659</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD , 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia .</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium is C66H74CaF2N4O13and its molecular weight is 1209.408. Its structural formula is:. Atorvastatin calcium USP is a white to off-white crystalline powder. It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.845 mg, 21.69 mg, 43.38 mg, or 86.76 mg of atorvastatin calcium trihydrate) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Atorvastatin calcium tablets meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>43598-121-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-121-05) </PackageDescription>
<NDC11Code>43598-0121-05</NDC11Code>
<ProductNDC>43598-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091023</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Inc</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Clopidogrel tablets USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate USP is C16H16Cl NO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate USP is a white to off-white powder. It is freely soluble in methanol and practically insoluble in ether. It has a specific optical rotation of between +53° and + 58°. Clopidogrel for oral administration is provided as pink, round, biconvex, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent to 75 mg of clopidogrel base or pink, oval, film-coated tablets containing 391.5 mg of clopidogrel bisulfate USP which is the molar equivalent to 300 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate as inactive ingredients. The film-coating contains hypromellose 2910, iron oxide red, polyethylene glycol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43598-122-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-122-05) </PackageDescription>
<NDC11Code>43598-0122-05</NDC11Code>
<ProductNDC>43598-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel Bisulfate</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091023</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Inc</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Clopidogrel tablets USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisulfate USP is C16H16Cl NO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate USP is a white to off-white powder. It is freely soluble in methanol and practically insoluble in ether. It has a specific optical rotation of between +53° and + 58°. Clopidogrel for oral administration is provided as pink, round, biconvex, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent to 75 mg of clopidogrel base or pink, oval, film-coated tablets containing 391.5 mg of clopidogrel bisulfate USP which is the molar equivalent to 300 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, lactose monohydrate, microcrystalline cellulose and sodium stearyl fumarate as inactive ingredients. The film-coating contains hypromellose 2910, iron oxide red, polyethylene glycol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43598-131-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-131-05) </PackageDescription>
<NDC11Code>43598-0131-05</NDC11Code>
<ProductNDC>43598-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210441</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine Sulfate Tablets are an antimalarial and antirheumatic indicated for the. Limitations of Use (1.1): Hydroxychloroquine Sulfate Tablets are not recommended for the.</IndicationAndUsage>
<Description>Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. The chemical name for hydroxychloroquine sulfate is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1). Its structural formula is. The molecular weight of hydroxychloroquine sulfate is 433.95, and molecular formula is C18H26CIN3OH2SO4. Hydroxychloroquine Sulfate Tablets, USP contains 100 mg hydroxychloroquine sulfate, equivalent to 77.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contains 300 mg hydroxychloroquine sulfate, equivalent to 232.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide. Hydroxychloroquine Sulfate Tablets, USP contain 400 mg hydroxychloroquine sulfate, equivalent to 310 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>43598-132-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-132-05) </PackageDescription>
<NDC11Code>43598-0132-05</NDC11Code>
<ProductNDC>43598-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210441</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine Sulfate Tablets are an antimalarial and antirheumatic indicated for the. Limitations of Use (1.1): Hydroxychloroquine Sulfate Tablets are not recommended for the.</IndicationAndUsage>
<Description>Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. The chemical name for hydroxychloroquine sulfate is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1). Its structural formula is. The molecular weight of hydroxychloroquine sulfate is 433.95, and molecular formula is C18H26CIN3OH2SO4. Hydroxychloroquine Sulfate Tablets, USP contains 100 mg hydroxychloroquine sulfate, equivalent to 77.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contains 300 mg hydroxychloroquine sulfate, equivalent to 232.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide. Hydroxychloroquine Sulfate Tablets, USP contain 400 mg hydroxychloroquine sulfate, equivalent to 310 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>43598-133-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-133-05) </PackageDescription>
<NDC11Code>43598-0133-05</NDC11Code>
<ProductNDC>43598-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221024</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210441</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine Sulfate Tablets are an antimalarial and antirheumatic indicated for the. Limitations of Use (1.1): Hydroxychloroquine Sulfate Tablets are not recommended for the.</IndicationAndUsage>
<Description>Hydroxychloroquine sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. The chemical name for hydroxychloroquine sulfate is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1). Its structural formula is. The molecular weight of hydroxychloroquine sulfate is 433.95, and molecular formula is C18H26CIN3OH2SO4. Hydroxychloroquine Sulfate Tablets, USP contains 100 mg hydroxychloroquine sulfate, equivalent to 77.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Hydroxychloroquine Sulfate Tablets, USP contains 300 mg hydroxychloroquine sulfate, equivalent to 232.5 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow iron oxide. Hydroxychloroquine Sulfate Tablets, USP contain 400 mg hydroxychloroquine sulfate, equivalent to 310 mg base, and are for oral administration. Inactive Ingredients: corn starch, crospovidone, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>43598-164-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-164-05) </PackageDescription>
<NDC11Code>43598-0164-05</NDC11Code>
<ProductNDC>43598-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-165-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-165-05) </PackageDescription>
<NDC11Code>43598-0165-05</NDC11Code>
<ProductNDC>43598-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-166-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (43598-166-05) </PackageDescription>
<NDC11Code>43598-0166-05</NDC11Code>
<ProductNDC>43598-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076255</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. This product meets the requirements of USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>43598-172-15</NDCCode>
<PackageDescription>10 AMPULE in 1 CARTON (43598-172-15) / 5 mL in 1 AMPULE (43598-172-05) </PackageDescription>
<NDC11Code>43598-0172-15</NDC11Code>
<ProductNDC>43598-172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Biorphen</ProprietaryName>
<NonProprietaryName>Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20221125</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212909</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIORPHEN is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.</IndicationAndUsage>
<Description>Phenylephrine is an alpha-1 adrenergic receptor agonist. The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α-[(methylamino) methyl] benzyl alcohol hydrochloride, its molecular formula is C9H13NO2· HCl (Molecular Weight: 203.67g/mol). Its structural formula is depicted below. Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. BIORPHEN Injection, 500 mcg/5 mL (100 mcg/mL). BIORPHEN (phenylephrine hydrochloride) injection, 500 mcg/5 mL (100 mcg/mL),, is a sterile, nonpyrogenic, clear and colorless solution for intravenous use. It MUST NOT BE DILUTED before administration as an intravenous bolus. Each mL contains: phenylephrine hydrochloride 100 mcg (equivalent to 80 mcg of phenylephrine base), sodium chloride 9.0 mg in water for injection. The pH is adjusted with hydrochloric acid if necessary. The pH range is 3.0 to 5.0. BIORPHEN Injection, 10 mg/mL. BIORPHEN (phenylephrine hydrochloride) injection, 10 mg/mL, is a sterile, nonpyrogenic, clear and colorless solution for intravenous use. It MUST BE DILUTED before administration as an intravenous bolus or continuous intravenous infusion. Each mL contains: phenylephrine hydrochloride 10 mg (equivalent to 8.2 mg of phenylephrine base), sodium chloride 6.0 mg in water for injection. The pH is adjusted with hydrochloric acid if necessary. The pH range is 3.0 to 5.0.</Description>
</NDC>
</NDCList>