{
"NDC": [
{
"NDCCode": "68428-949-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-949-11)",
"NDC11Code": "68428-0949-11",
"ProductNDC": "68428-949",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Helix Tosta",
"NonProprietaryName": "Escargot Shell, Cooked",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ESCARGOT SHELL, COOKED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. HELIX Tickling cough."
},
{
"NDCCode": "68428-949-03",
"PackageDescription": "75 PELLET in 1 VIAL, GLASS (68428-949-03)",
"NDC11Code": "68428-0949-03",
"ProductNDC": "68428-949",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Helix Tosta",
"NonProprietaryName": "Escargot Shell, Cooked",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ESCARGOT SHELL, COOKED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. HELIX Tickling cough."
},
{
"NDCCode": "68428-949-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-949-05)",
"NDC11Code": "68428-0949-05",
"ProductNDC": "68428-949",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Helix Tosta",
"NonProprietaryName": "Escargot Shell, Cooked",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ESCARGOT SHELL, COOKED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. HELIX Tickling cough."
},
{
"NDCCode": "68428-949-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-949-06)",
"NDC11Code": "68428-0949-06",
"ProductNDC": "68428-949",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Helix Tosta",
"NonProprietaryName": "Escargot Shell, Cooked",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ESCARGOT SHELL, COOKED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. HELIX Tickling cough."
},
{
"NDCCode": "68428-949-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-949-12)",
"NDC11Code": "68428-0949-12",
"ProductNDC": "68428-949",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Helix Tosta",
"NonProprietaryName": "Escargot Shell, Cooked",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ESCARGOT SHELL, COOKED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "Indications. HELIX Tickling cough."
},
{
"NDCCode": "42385-949-11",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (42385-949-11) ",
"NDC11Code": "42385-0949-11",
"ProductNDC": "42385-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209882",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210517",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are 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. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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": "60687-949-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-949-01) / 1 TABLET, SUGAR COATED in 1 BLISTER PACK (60687-949-11) ",
"NDC11Code": "60687-0949-01",
"ProductNDC": "60687-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214827",
"LabelerName": "American Health Packaging",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260517",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, USP a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. Its molecular formula is C 17H 19ClN 2S.HCL and its molecular weight is 355.33. It is available in tablets for oral administration. It has the following structural formula:. Chlorpromazine hydrochloride occurs as white to off-white powder. Each tablet for oral administration contains 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine HCl, USP. Inactive Ingredients: croscarmellose sodium, glyceryl monostreate, hypromellose, iron oxide yellow, iron oxide red, isopropyl alcohol, lactose monohydrate, magnesium sterate, medium chain triglycerides, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, precipitated calcium carbonate, sucrose, talc, titanium dioxide. The printing ink contains shellac, ferrosoferric oxide, propylene glycol."
},
{
"NDCCode": "62756-949-11",
"PackageDescription": "25 kg in 1 DRUM (62756-949-11) ",
"NDC11Code": "62756-0949-11",
"ProductNDC": "62756-949",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dabigatran Etexilate Mesylate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20210116",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SUN PHARMACEUTICAL INDUSTRIES, INC.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "25",
"StrengthUnit": "kg/25kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-30",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "16-JAN-21"
},
{
"NDCCode": "63304-949-17",
"PackageDescription": "10 POUCH in 1 BOX, UNIT-DOSE (63304-949-17) > 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-949-11) ",
"NDC11Code": "63304-0949-17",
"ProductNDC": "63304-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20100806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077542",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2022-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100806",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone orally disintegrating tablet is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).",
"Description": "Risperidone orally disintegrating tablets contain risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)‑1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H- pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to off white powder. It is practically insoluble in water, soluble in methylene chloride, and sparingly soluble in alcohol. Risperidone orally disintegrating tablets are for oral administration and available as 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg pink tablets. Inactive ingredients are aspartame*, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, flavor peppermint, low substituted hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, menthol, saccharin sodium and talc. *[see Patient Counseling Information (17.7)]."
},
{
"NDCCode": "68084-949-21",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-949-21) > 1 TABLET in 1 BLISTER PACK (68084-949-11)",
"NDC11Code": "68084-0949-21",
"ProductNDC": "68084-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072637",
"LabelerName": "American Health Packaging",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "71141-949-11",
"PackageDescription": "237 mL in 1 BOTTLE (71141-949-11) ",
"NDC11Code": "71141-0949-11",
"ProductNDC": "71141-949",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cien Sun By Lidl Sport Sunscreen Broad Spectrum Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170601",
"EndMarketingDate": "20250419",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "LIDL US LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 60",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170601",
"EndMarketingDatePackage": "20250419",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "82804-949-11",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (82804-949-11) ",
"NDC11Code": "82804-0949-11",
"ProductNDC": "82804-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212988",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260527",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "0054-0273-13",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0054-0273-13) ",
"NDC11Code": "00054-0273-13",
"ProductNDC": "0054-0273",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Pamoate",
"NonProprietaryName": "Imipramine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091099",
"LabelerName": "Hikma Pharmaceuticals USA Inc",
"SubstanceName": "IMIPRAMINE PAMOATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100419",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.",
"Description": "Imipramine Pamoate Capsules, USP are a tricyclic antidepressant, available as capsules for oral administration. The 75 mg, 100 mg, 125 mg, and 150 mg capsules contain imipramine pamoate, USP equivalent to 75 mg, 100 mg, 125 mg, and 150 mg of imipramine hydrochloride. Imipramine pamoate, USP is 5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine 4, 4'-methylenebis-(3-hydroxy-2-naphthoate) (2:1), and its structural formula is. (C19H24N2)2●C23H16O6 M.W. = 949.18. Imipramine pamoate, USP is a slightly yellow, crystalline powder. It is soluble in ethanol, in acetone, in ether, in chloroform, and in carbon tetrachloride, and is insoluble in water. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. Gelatin capsule shells contain FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsules also contain FD&C Yellow No. 10. The 125 mg capsules also contain FD&C Yellow No. 5. In addition to the ingredients listed above, each capsule contains iron oxide used in the black monogramming ink."
},
{
"NDCCode": "0054-0274-13",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0054-0274-13) ",
"NDC11Code": "00054-0274-13",
"ProductNDC": "0054-0274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Pamoate",
"NonProprietaryName": "Imipramine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091099",
"LabelerName": "Hikma Pharmaceuticals USA Inc",
"SubstanceName": "IMIPRAMINE PAMOATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100419",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.",
"Description": "Imipramine Pamoate Capsules, USP are a tricyclic antidepressant, available as capsules for oral administration. The 75 mg, 100 mg, 125 mg, and 150 mg capsules contain imipramine pamoate, USP equivalent to 75 mg, 100 mg, 125 mg, and 150 mg of imipramine hydrochloride. Imipramine pamoate, USP is 5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine 4, 4'-methylenebis-(3-hydroxy-2-naphthoate) (2:1), and its structural formula is. (C19H24N2)2●C23H16O6 M.W. = 949.18. Imipramine pamoate, USP is a slightly yellow, crystalline powder. It is soluble in ethanol, in acetone, in ether, in chloroform, and in carbon tetrachloride, and is insoluble in water. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. Gelatin capsule shells contain FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsules also contain FD&C Yellow No. 10. The 125 mg capsules also contain FD&C Yellow No. 5. In addition to the ingredients listed above, each capsule contains iron oxide used in the black monogramming ink."
},
{
"NDCCode": "0054-0275-13",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0054-0275-13) ",
"NDC11Code": "00054-0275-13",
"ProductNDC": "0054-0275",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Pamoate",
"NonProprietaryName": "Imipramine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091099",
"LabelerName": "Hikma Pharmaceuticals USA Inc",
"SubstanceName": "IMIPRAMINE PAMOATE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100419",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.",
"Description": "Imipramine Pamoate Capsules, USP are a tricyclic antidepressant, available as capsules for oral administration. The 75 mg, 100 mg, 125 mg, and 150 mg capsules contain imipramine pamoate, USP equivalent to 75 mg, 100 mg, 125 mg, and 150 mg of imipramine hydrochloride. Imipramine pamoate, USP is 5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine 4, 4'-methylenebis-(3-hydroxy-2-naphthoate) (2:1), and its structural formula is. (C19H24N2)2●C23H16O6 M.W. = 949.18. Imipramine pamoate, USP is a slightly yellow, crystalline powder. It is soluble in ethanol, in acetone, in ether, in chloroform, and in carbon tetrachloride, and is insoluble in water. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. Gelatin capsule shells contain FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsules also contain FD&C Yellow No. 10. The 125 mg capsules also contain FD&C Yellow No. 5. In addition to the ingredients listed above, each capsule contains iron oxide used in the black monogramming ink."
},
{
"NDCCode": "0054-0276-13",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0054-0276-13) ",
"NDC11Code": "00054-0276-13",
"ProductNDC": "0054-0276",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imipramine Pamoate",
"NonProprietaryName": "Imipramine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091099",
"LabelerName": "Hikma Pharmaceuticals USA Inc",
"SubstanceName": "IMIPRAMINE PAMOATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100419",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.",
"Description": "Imipramine Pamoate Capsules, USP are a tricyclic antidepressant, available as capsules for oral administration. The 75 mg, 100 mg, 125 mg, and 150 mg capsules contain imipramine pamoate, USP equivalent to 75 mg, 100 mg, 125 mg, and 150 mg of imipramine hydrochloride. Imipramine pamoate, USP is 5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine 4, 4'-methylenebis-(3-hydroxy-2-naphthoate) (2:1), and its structural formula is. (C19H24N2)2●C23H16O6 M.W. = 949.18. Imipramine pamoate, USP is a slightly yellow, crystalline powder. It is soluble in ethanol, in acetone, in ether, in chloroform, and in carbon tetrachloride, and is insoluble in water. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. Gelatin capsule shells contain FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsules also contain FD&C Yellow No. 10. The 125 mg capsules also contain FD&C Yellow No. 5. In addition to the ingredients listed above, each capsule contains iron oxide used in the black monogramming ink."
},
{
"NDCCode": "10544-949-14",
"PackageDescription": "14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (10544-949-14)",
"NDC11Code": "10544-0949-14",
"ProductNDC": "10544-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium And Misoprostol",
"NonProprietaryName": "Diclofenac Sodium And Misoprostol",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20151007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201089",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "75; 200",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. See WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation for a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications.",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets are a combination product containing diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E1 analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex tablets, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg or 75 mg diclofenac sodium surrounded by an outer mantle containing 0.2 mg misoprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl- 9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hydrogenated castor oil; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer dispersion; microcrystalline cellulose; povidone (polyvidone) K-30; sodium hydroxide; starch (corn); talc; triethyl citrate."
},
{
"NDCCode": "14593-949-01",
"PackageDescription": "15 kg in 1 DRUM (14593-949-01) ",
"NDC11Code": "14593-0949-01",
"ProductNDC": "14593-949",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ebm-n-3 Intermediate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230616",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Emcure Pharmaceuticals Limited",
"SubstanceName": "ERIBULIN",
"StrengthNumber": "15",
"StrengthUnit": "kg/15kg",
"Status": "Unfinished",
"LastUpdate": "2025-11-27",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "16-JUN-23"
},
{
"NDCCode": "16714-949-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16714-949-01) ",
"NDC11Code": "16714-0949-01",
"ProductNDC": "16714-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202424",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "1.875; 1.875; 1.875; 1.875",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190320",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; \"on the go;\" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of Dextroamphetamine and amphetamine, with the Dextro isomer of amphetamine Saccharate and d, 1-amphetamine aspartate. 11.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied21.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied32.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied43.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied55 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as supplied67.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients. In addition, each tablet contains: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch. Colors. The 5 mg, 7.5 mg, and 10 mg tablets contain the color additive FD&C Blue #1 Aluminum Lake. The 15 mg, 20 mg, and 30 mg tablets contain the color additive FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "30142-949-30",
"PackageDescription": "180 mL in 1 BOTTLE (30142-949-30) ",
"NDC11Code": "30142-0949-30",
"ProductNDC": "30142-949",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Night Time Cold And Flu",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20190522",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 25; 10",
"StrengthUnit": "mg/20mL; mg/20mL; mg/20mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190522",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms:. cough . nasal congestion . minor aches and pains . sinus congestion and pressure. sore throat . headache . runny nose . sneezing. temporarily reduces fever. controls cough to help you get to sleep."
},
{
"NDCCode": "41250-949-35",
"PackageDescription": "769 mL in 1 BOTTLE (41250-949-35) ",
"NDC11Code": "41250-0949-35",
"ProductNDC": "41250-949",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Milk Of Magnesia",
"NonProprietaryName": "Magnesium Hydroxide",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20041018",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "MAGNESIUM HYDROXIDE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20041018",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces bowel movement in ½ to 6 hours."
},
{
"NDCCode": "41250-949-40",
"PackageDescription": "355 mL in 1 BOTTLE (41250-949-40)",
"NDC11Code": "41250-0949-40",
"ProductNDC": "41250-949",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Milk Of Magnesia",
"NonProprietaryName": "Magnesium Hydroxide",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20041018",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "MAGNESIUM HYDROXIDE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2018-11-08",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "41520-949-40",
"PackageDescription": "355 mL in 1 BOTTLE (41520-949-40)",
"NDC11Code": "41520-0949-40",
"ProductNDC": "41520-949",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Careone Milk Of Magnesia",
"NonProprietaryName": "Magnesium Hydroxide",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20120826",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "American Sales Company",
"SubstanceName": "MAGNESIUM HYDROXIDE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces bowel movement in ½ to 6 hours."
},
{
"NDCCode": "42385-949-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (42385-949-01) ",
"NDC11Code": "42385-0949-01",
"ProductNDC": "42385-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209882",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210720",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are 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. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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": "42385-949-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42385-949-05) ",
"NDC11Code": "42385-0949-05",
"ProductNDC": "42385-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209882",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210720",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are 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. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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": "42385-949-18",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (42385-949-18) ",
"NDC11Code": "42385-0949-18",
"ProductNDC": "42385-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209882",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210720",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are 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. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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": "42385-949-19",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (42385-949-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "42385-0949-19",
"ProductNDC": "42385-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209882",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210517",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are 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. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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": "42385-949-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (42385-949-60) ",
"NDC11Code": "42385-0949-60",
"ProductNDC": "42385-949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209882",
"LabelerName": "Laurus Labs Limited",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
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"Description": "Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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."
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"Description": "Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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."
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<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
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<ProprietaryName>Albuterol Sulfate</ProprietaryName>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin Capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in 1N Hydrochloric acid and sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide, sodium lauryl sulfate and water. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain red iron oxide. Colloidal silicon dioxide is used as processing aid. The imprinting ink contains shellac, black iron oxide, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0054-0273-13</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0054-0273-13) </PackageDescription>
<NDC11Code>00054-0273-13</NDC11Code>
<ProductNDC>0054-0273</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Pamoate</ProprietaryName>
<NonProprietaryName>Imipramine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091099</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc</LabelerName>
<SubstanceName>IMIPRAMINE PAMOATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.</IndicationAndUsage>
<Description>Imipramine Pamoate Capsules, USP are a tricyclic antidepressant, available as capsules for oral administration. The 75 mg, 100 mg, 125 mg, and 150 mg capsules contain imipramine pamoate, USP equivalent to 75 mg, 100 mg, 125 mg, and 150 mg of imipramine hydrochloride. Imipramine pamoate, USP is 5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine 4, 4'-methylenebis-(3-hydroxy-2-naphthoate) (2:1), and its structural formula is. (C19H24N2)2●C23H16O6 M.W. = 949.18. Imipramine pamoate, USP is a slightly yellow, crystalline powder. It is soluble in ethanol, in acetone, in ether, in chloroform, and in carbon tetrachloride, and is insoluble in water. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. Gelatin capsule shells contain FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsules also contain FD&C Yellow No. 10. The 125 mg capsules also contain FD&C Yellow No. 5. In addition to the ingredients listed above, each capsule contains iron oxide used in the black monogramming ink.</Description>
</NDC>
<NDC>
<NDCCode>0054-0274-13</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0054-0274-13) </PackageDescription>
<NDC11Code>00054-0274-13</NDC11Code>
<ProductNDC>0054-0274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Pamoate</ProprietaryName>
<NonProprietaryName>Imipramine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091099</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc</LabelerName>
<SubstanceName>IMIPRAMINE PAMOATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.</IndicationAndUsage>
<Description>Imipramine Pamoate Capsules, USP are a tricyclic antidepressant, available as capsules for oral administration. The 75 mg, 100 mg, 125 mg, and 150 mg capsules contain imipramine pamoate, USP equivalent to 75 mg, 100 mg, 125 mg, and 150 mg of imipramine hydrochloride. Imipramine pamoate, USP is 5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine 4, 4'-methylenebis-(3-hydroxy-2-naphthoate) (2:1), and its structural formula is. (C19H24N2)2●C23H16O6 M.W. = 949.18. Imipramine pamoate, USP is a slightly yellow, crystalline powder. It is soluble in ethanol, in acetone, in ether, in chloroform, and in carbon tetrachloride, and is insoluble in water. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. Gelatin capsule shells contain FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsules also contain FD&C Yellow No. 10. The 125 mg capsules also contain FD&C Yellow No. 5. In addition to the ingredients listed above, each capsule contains iron oxide used in the black monogramming ink.</Description>
</NDC>
<NDC>
<NDCCode>0054-0275-13</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0054-0275-13) </PackageDescription>
<NDC11Code>00054-0275-13</NDC11Code>
<ProductNDC>0054-0275</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Pamoate</ProprietaryName>
<NonProprietaryName>Imipramine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091099</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc</LabelerName>
<SubstanceName>IMIPRAMINE PAMOATE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.</IndicationAndUsage>
<Description>Imipramine Pamoate Capsules, USP are a tricyclic antidepressant, available as capsules for oral administration. The 75 mg, 100 mg, 125 mg, and 150 mg capsules contain imipramine pamoate, USP equivalent to 75 mg, 100 mg, 125 mg, and 150 mg of imipramine hydrochloride. Imipramine pamoate, USP is 5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine 4, 4'-methylenebis-(3-hydroxy-2-naphthoate) (2:1), and its structural formula is. (C19H24N2)2●C23H16O6 M.W. = 949.18. Imipramine pamoate, USP is a slightly yellow, crystalline powder. It is soluble in ethanol, in acetone, in ether, in chloroform, and in carbon tetrachloride, and is insoluble in water. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. Gelatin capsule shells contain FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsules also contain FD&C Yellow No. 10. The 125 mg capsules also contain FD&C Yellow No. 5. In addition to the ingredients listed above, each capsule contains iron oxide used in the black monogramming ink.</Description>
</NDC>
<NDC>
<NDCCode>0054-0276-13</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0054-0276-13) </PackageDescription>
<NDC11Code>00054-0276-13</NDC11Code>
<ProductNDC>0054-0276</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imipramine Pamoate</ProprietaryName>
<NonProprietaryName>Imipramine Pamoate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091099</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc</LabelerName>
<SubstanceName>IMIPRAMINE PAMOATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.</IndicationAndUsage>
<Description>Imipramine Pamoate Capsules, USP are a tricyclic antidepressant, available as capsules for oral administration. The 75 mg, 100 mg, 125 mg, and 150 mg capsules contain imipramine pamoate, USP equivalent to 75 mg, 100 mg, 125 mg, and 150 mg of imipramine hydrochloride. Imipramine pamoate, USP is 5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine 4, 4'-methylenebis-(3-hydroxy-2-naphthoate) (2:1), and its structural formula is. (C19H24N2)2●C23H16O6 M.W. = 949.18. Imipramine pamoate, USP is a slightly yellow, crystalline powder. It is soluble in ethanol, in acetone, in ether, in chloroform, and in carbon tetrachloride, and is insoluble in water. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch, sodium starch glycolate and talc. Gelatin capsule shells contain FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsules also contain FD&C Yellow No. 10. The 125 mg capsules also contain FD&C Yellow No. 5. In addition to the ingredients listed above, each capsule contains iron oxide used in the black monogramming ink.</Description>
</NDC>
<NDC>
<NDCCode>10544-949-14</NDCCode>
<PackageDescription>14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (10544-949-14)</PackageDescription>
<NDC11Code>10544-0949-14</NDC11Code>
<ProductNDC>10544-949</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium And Misoprostol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201089</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>75; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. See WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation for a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications.</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets are a combination product containing diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E1 analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex tablets, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg or 75 mg diclofenac sodium surrounded by an outer mantle containing 0.2 mg misoprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl- 9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hydrogenated castor oil; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer dispersion; microcrystalline cellulose; povidone (polyvidone) K-30; sodium hydroxide; starch (corn); talc; triethyl citrate.</Description>
</NDC>
<NDC>
<NDCCode>14593-949-01</NDCCode>
<PackageDescription>15 kg in 1 DRUM (14593-949-01) </PackageDescription>
<NDC11Code>14593-0949-01</NDC11Code>
<ProductNDC>14593-949</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ebm-n-3 Intermediate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230616</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
<SubstanceName>ERIBULIN</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>kg/15kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-11-27</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-JUN-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>16714-949-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16714-949-01) </PackageDescription>
<NDC11Code>16714-0949-01</NDC11Code>
<ProductNDC>16714-949</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202424</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>1.875; 1.875; 1.875; 1.875</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of Dextroamphetamine and amphetamine, with the Dextro isomer of amphetamine Saccharate and d, 1-amphetamine aspartate. 11.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied21.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied32.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied43.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied55 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as supplied67.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied. Inactive Ingredients. In addition, each tablet contains: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch. Colors. The 5 mg, 7.5 mg, and 10 mg tablets contain the color additive FD&C Blue #1 Aluminum Lake. The 15 mg, 20 mg, and 30 mg tablets contain the color additive FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>30142-949-30</NDCCode>
<PackageDescription>180 mL in 1 BOTTLE (30142-949-30) </PackageDescription>
<NDC11Code>30142-0949-30</NDC11Code>
<ProductNDC>30142-949</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Night Time Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190522</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 25; 10</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms:. cough . nasal congestion . minor aches and pains . sinus congestion and pressure. sore throat . headache . runny nose . sneezing. temporarily reduces fever. controls cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41250-949-35</NDCCode>
<PackageDescription>769 mL in 1 BOTTLE (41250-949-35) </PackageDescription>
<NDC11Code>41250-0949-35</NDC11Code>
<ProductNDC>41250-949</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Milk Of Magnesia</ProprietaryName>
<NonProprietaryName>Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041018</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in ½ to 6 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41250-949-40</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (41250-949-40)</PackageDescription>
<NDC11Code>41250-0949-40</NDC11Code>
<ProductNDC>41250-949</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Milk Of Magnesia</ProprietaryName>
<NonProprietaryName>Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041018</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-08</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>41520-949-40</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (41520-949-40)</PackageDescription>
<NDC11Code>41520-0949-40</NDC11Code>
<ProductNDC>41520-949</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Careone Milk Of Magnesia</ProprietaryName>
<NonProprietaryName>Magnesium Hydroxide</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20120826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces bowel movement in ½ to 6 hours.</IndicationAndUsage>
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<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (42385-949-01) </PackageDescription>
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<ProductNDC>42385-949</ProductNDC>
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<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209882</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are 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. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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>
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<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42385-949-05) </PackageDescription>
<NDC11Code>42385-0949-05</NDC11Code>
<ProductNDC>42385-949</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209882</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are 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. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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>42385-949-18</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (42385-949-18) </PackageDescription>
<NDC11Code>42385-0949-18</NDC11Code>
<ProductNDC>42385-949</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209882</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are 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. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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>42385-949-19</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (42385-949-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42385-0949-19</NDC11Code>
<ProductNDC>42385-949</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209882</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are 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. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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>42385-949-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42385-949-60) </PackageDescription>
<NDC11Code>42385-0949-60</NDC11Code>
<ProductNDC>42385-949</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209882</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are 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. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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>42385-949-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (42385-949-90) </PackageDescription>
<NDC11Code>42385-0949-90</NDC11Code>
<ProductNDC>42385-949</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209882</ApplicationNumber>
<LabelerName>Laurus Labs Limited</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are 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. Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets/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-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to 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 tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor. 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>49035-184-02</NDCCode>
<PackageDescription>949 mL in 1 BOTTLE, PUMP (49035-184-02) </PackageDescription>
<NDC11Code>49035-0184-02</NDC11Code>
<ProductNDC>49035-184</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Everyday Clean 2 In 1 Dandruff</ProprietaryName>
<ProprietaryNameSuffix>Anti-dandruff</ProprietaryNameSuffix>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc.</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent recurrence of flaking and itching associated with dandruff.</IndicationAndUsage>
</NDC>
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