{
"NDC": [
{
"NDCCode": "70771-1035-9",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1035-9) ",
"NDC11Code": "70771-1035-09",
"ProductNDC": "70771-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18."
},
{
"NDCCode": "70771-1035-0",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1035-0) ",
"NDC11Code": "70771-1035-00",
"ProductNDC": "70771-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18."
},
{
"NDCCode": "70771-1035-1",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1035-1) ",
"NDC11Code": "70771-1035-01",
"ProductNDC": "70771-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18."
},
{
"NDCCode": "70771-1035-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1035-3) ",
"NDC11Code": "70771-1035-03",
"ProductNDC": "70771-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18."
},
{
"NDCCode": "70771-1035-5",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1035-5) ",
"NDC11Code": "70771-1035-05",
"ProductNDC": "70771-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiadylt Er",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206641",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171108",
"SamplePackage": "N",
"IndicationAndUsage": "Tiadylt® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution test 18."
},
{
"NDCCode": "0220-1035-41",
"PackageDescription": "9 [hp_C] in 1 TUBE (0220-1035-41) ",
"NDC11Code": "00220-1035-41",
"ProductNDC": "0220-1035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Caladium Seguinum",
"NonProprietaryName": "Dieffenbachia Seguine",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "DIEFFENBACHIA SEGUINE",
"StrengthNumber": "9",
"StrengthUnit": "[hp_C]/9[hp_C]",
"Status": "Active",
"LastUpdate": "2023-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Intense itching*."
},
{
"NDCCode": "50184-1035-2",
"PackageDescription": "1 JAR in 1 BOX (50184-1035-2) > 9.1 g in 1 JAR (50184-1035-1)",
"NDC11Code": "50184-1035-02",
"ProductNDC": "50184-1035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Supernatural Airbrushed Canvas Broad Spectrum Spf 15 Sunscreen",
"ProprietaryNameSuffix": "Medium Beige",
"NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "philosophy",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": ".455; 5.49",
"StrengthUnit": "mg/9.1g; mg/9.1g",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "68745-1035-3",
"PackageDescription": ".9 mL in 1 PACKET (68745-1035-3)",
"NDC11Code": "68745-1035-03",
"ProductNDC": "68745-1035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitalumiere",
"ProprietaryNameSuffix": "Moisture-rich Radiance Sunscreen Fluid Makeup, Broad Spectrum Spf 15, 30 Cendre",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CHANEL PARFUMS BEAUTE",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-04-09",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "72162-1035-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (72162-1035-9) ",
"NDC11Code": "72162-1035-09",
"ProductNDC": "72162-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan And Hydrochlorothiazide",
"NonProprietaryName": "Irbesartan And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077369",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "IRBESARTAN; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "150; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260407",
"SamplePackage": "N",
"IndicationAndUsage": "Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy. Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide tablets compared to irbesartan or hydrochlorothiazide (HCTZ) monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with irbesartan and hydrochlorothiazide tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. Figure 1a: Probability of Achieving SBP <140 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*. Figure 1b: Probability of Achieving SBP <130 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*. Figure 2a: Probability of Achieving DBP <90 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*. Figure 2b: Probability of Achieving DBP <80 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*. * For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis). The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone). The likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets rises to about 40% (systolic) or 70% (diastolic).",
"Description": "Irbesartan and Hydrochlorothiazide Tablets USP are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, USP and a thiazide diuretic, hydrochlorothiazide (HCTZ), USP. Irbesartan, USP is a non-peptide compound, chemically described as a 2-Butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its structural formula is. C25H28N6O M.W. 428.5. Irbesartan, USP is a white to off-white crystalline powder. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan, USP is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide, USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its structural formula is. C7H8ClN3O4S2 M.W. 297.7. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. Hydrochlorothiazide, USP is very slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan, USP combined with 12.5 mg of hydrochlorothiazide, USP. Inactive ingredients include: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, povidone, pregelatinized corn starch and titanium dioxide."
},
{
"NDCCode": "85509-1035-9",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-9) ",
"NDC11Code": "85509-1035-09",
"ProductNDC": "85509-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091281",
"LabelerName": "PHOENIX RX LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260119",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. Limitations of Use: 1 Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted., 2 Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride extended-release capsules USP are skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in cyclobenzaprine hydrochloride extended-release capsules is cyclobenzaprine hydrochloride, USP. Cyclobenzaprine hydrochloride (HCl) is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK aof 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride extended-release capsules for oral administration are supplied in 15 and 30 mg strengths. Cyclobenzaprine hydrochloride extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl alcohol, ethylcellulose, FDC yellow #6, gelatin, hydroxypropyl cellulose, isopropyl alcohol, potassium hydroxide, sugar spheres (which contain sucrose and corn starch) and titanium dioxide. In addition, red iron oxide is also included in the 15 mg strength. The capsule is imprinted with black ink consisting of: black iron oxide, DC Yellow #10, ethanol, FDC Blue #1, FDC Blue #2, FDC Red #40, methanol, N-butyl alcohol, propylene glycol, and shellac."
},
{
"NDCCode": "0121-1035-55",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 CARTON (0121-1035-55) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00121-1035-55",
"ProductNDC": "0121-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lincomycin",
"NonProprietaryName": "Lincomycin Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20241007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212770",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "LINCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "3000",
"StrengthUnit": "mg/10mL",
"Status": "Active",
"LastUpdate": "2024-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241007",
"SamplePackage": "N",
"IndicationAndUsage": "Lincomycin Injection sterile solution is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. The drug may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin Injection and other antibacterial drugs, Lincomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Lincomycin Injection, USP sterile solution contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2- pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C 18H34N 2O 6S●HCl●H 2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. Each mL contains lincomycin hydrochloride equivalent to 300 mg lincomycin. Also contains 9.45 mg benzyl alcohol added as a preservative."
},
{
"NDCCode": "10191-1035-2",
"PackageDescription": "170 PELLET in 1 VIAL, GLASS (10191-1035-2) ",
"NDC11Code": "10191-1035-02",
"ProductNDC": "10191-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Codeinum",
"NonProprietaryName": "Codeine",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20150714",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Remedy Makers",
"SubstanceName": "CODEINE ANHYDROUS",
"StrengthNumber": "9",
"StrengthUnit": "[hp_X]/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150714",
"SamplePackage": "N",
"IndicationAndUsage": "VERTIGO, DIARRHEA, PAIN OR OTHER INDICATIONS."
},
{
"NDCCode": "43742-1035-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-1035-1) ",
"NDC11Code": "43742-1035-01",
"ProductNDC": "43742-1035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bio Lymph Phase",
"NonProprietaryName": "Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (smilax Regelii), Ascorbicum Acidum, Quercetin, Myosotis Arvensis, Calcarea Phosphorica, Ferrum Iodatum, Thyroidinum (suis), Gaertner Bacillus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170720",
"EndMarketingDate": "20240723",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "ARANEUS DIADEMATUS; ASCORBIC ACID; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PINUS SYLVESTRIS LEAFY TWIG; QUERCETIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SCROPHULARIA NODOSA; SMILAX ORNATA ROOT; SODIUM SULFATE; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "6; 6; 4; 12; 4; 5; 4; 5; 5; 9; 4; 4; 6; 30; 3; 6; 4; 12; 3; 12; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170720",
"EndMarketingDatePackage": "20240723",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of swelling due to minor injury.**. **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "70121-1035-5",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1035-5) / 2 mL in 1 VIAL, SINGLE-DOSE (70121-1035-1) ",
"NDC11Code": "70121-1035-05",
"ProductNDC": "70121-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paricalcitol",
"NonProprietaryName": "Paricalcitol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206699",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PARICALCITOL",
"StrengthNumber": "10",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Ergocalciferols [CS], Vitamin D Analog [EPC], Vitamin D2 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170309",
"SamplePackage": "N",
"IndicationAndUsage": "Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.",
"Description": "Paricalcitol, USP is a synthetically manufactured active vitamin D analog. It is a white to almost white powder chemically designated as (1α,3β,7E,22E)-19-Nor-9,10-secoergosta-5,7,22-triene-1,3,25-triol and has the following structural formula. Molecular formula is C27H44O3. Molecular weight is 416.64 g/mol. Paricalcitol injection, USP is a sterile, aqueous solution for intravenous use. Each mL contains paricalcitol USP, 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 20% (v/v) and propylene glycol, 30% (v/v)."
},
{
"NDCCode": "70121-1035-7",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1035-7) / 2 mL in 1 VIAL, SINGLE-DOSE (70121-1035-1) ",
"NDC11Code": "70121-1035-07",
"ProductNDC": "70121-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paricalcitol",
"NonProprietaryName": "Paricalcitol",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206699",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PARICALCITOL",
"StrengthNumber": "10",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Ergocalciferols [CS], Vitamin D Analog [EPC], Vitamin D2 Analog [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170309",
"SamplePackage": "N",
"IndicationAndUsage": "Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.",
"Description": "Paricalcitol, USP is a synthetically manufactured active vitamin D analog. It is a white to almost white powder chemically designated as (1α,3β,7E,22E)-19-Nor-9,10-secoergosta-5,7,22-triene-1,3,25-triol and has the following structural formula. Molecular formula is C27H44O3. Molecular weight is 416.64 g/mol. Paricalcitol injection, USP is a sterile, aqueous solution for intravenous use. Each mL contains paricalcitol USP, 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 20% (v/v) and propylene glycol, 30% (v/v)."
},
{
"NDCCode": "85509-1035-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-3) ",
"NDC11Code": "85509-1035-03",
"ProductNDC": "85509-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091281",
"LabelerName": "PHOENIX RX LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260119",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. Limitations of Use: 1 Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted., 2 Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride extended-release capsules USP are skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in cyclobenzaprine hydrochloride extended-release capsules is cyclobenzaprine hydrochloride, USP. Cyclobenzaprine hydrochloride (HCl) is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK aof 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride extended-release capsules for oral administration are supplied in 15 and 30 mg strengths. Cyclobenzaprine hydrochloride extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl alcohol, ethylcellulose, FDC yellow #6, gelatin, hydroxypropyl cellulose, isopropyl alcohol, potassium hydroxide, sugar spheres (which contain sucrose and corn starch) and titanium dioxide. In addition, red iron oxide is also included in the 15 mg strength. The capsule is imprinted with black ink consisting of: black iron oxide, DC Yellow #10, ethanol, FDC Blue #1, FDC Blue #2, FDC Red #40, methanol, N-butyl alcohol, propylene glycol, and shellac."
},
{
"NDCCode": "85509-1035-6",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-6) ",
"NDC11Code": "85509-1035-06",
"ProductNDC": "85509-1035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091281",
"LabelerName": "PHOENIX RX LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260119",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. Limitations of Use: 1 Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted., 2 Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride extended-release capsules USP are skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in cyclobenzaprine hydrochloride extended-release capsules is cyclobenzaprine hydrochloride, USP. Cyclobenzaprine hydrochloride (HCl) is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK aof 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride extended-release capsules for oral administration are supplied in 15 and 30 mg strengths. Cyclobenzaprine hydrochloride extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl alcohol, ethylcellulose, FDC yellow #6, gelatin, hydroxypropyl cellulose, isopropyl alcohol, potassium hydroxide, sugar spheres (which contain sucrose and corn starch) and titanium dioxide. In addition, red iron oxide is also included in the 15 mg strength. The capsule is imprinted with black ink consisting of: black iron oxide, DC Yellow #10, ethanol, FDC Blue #1, FDC Blue #2, FDC Red #40, methanol, N-butyl alcohol, propylene glycol, and shellac."
},
{
"NDCCode": "70771-1012-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (70771-1012-9) ",
"NDC11Code": "70771-1012-09",
"ProductNDC": "70771-1012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208961",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180503",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1013-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (70771-1013-9) ",
"NDC11Code": "70771-1013-09",
"ProductNDC": "70771-1013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208961",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180503",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1014-9",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (70771-1014-9) ",
"NDC11Code": "70771-1014-09",
"ProductNDC": "70771-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clomipramine Hydrochloride",
"NonProprietaryName": "Clomipramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208961",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "CLOMIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180503",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1015-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1015-9) ",
"NDC11Code": "70771-1015-09",
"ProductNDC": "70771-1015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nateglinide",
"NonProprietaryName": "Nateglinide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205248",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "NATEGLINIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glinide [EPC], Potassium Channel Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161027",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1016-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1016-9) ",
"NDC11Code": "70771-1016-09",
"ProductNDC": "70771-1016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nateglinide",
"NonProprietaryName": "Nateglinide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161027",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205248",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "NATEGLINIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glinide [EPC], Potassium Channel Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161027",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1019-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1019-9) ",
"NDC11Code": "70771-1019-09",
"ProductNDC": "70771-1019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Entecavir",
"NonProprietaryName": "Entecavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206745",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "ENTECAVIR",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170810",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1020-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1020-9) ",
"NDC11Code": "70771-1020-09",
"ProductNDC": "70771-1020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Entecavir",
"NonProprietaryName": "Entecavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206745",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "ENTECAVIR",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170810",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1021-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (70771-1021-9) ",
"NDC11Code": "70771-1021-09",
"ProductNDC": "70771-1021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202456",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20161116",
"SamplePackage": "N"
},
{
"NDCCode": "70771-1022-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (70771-1022-9) ",
"NDC11Code": "70771-1022-09",
"ProductNDC": "70771-1022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202456",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
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<Status>Deprecated</Status>
<LastUpdate>2018-04-09</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>72162-1035-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (72162-1035-9) </PackageDescription>
<NDC11Code>72162-1035-09</NDC11Code>
<ProductNDC>72162-1035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irbesartan And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Irbesartan And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077369</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>IRBESARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>150; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy. Data from Studies V and VI [see Clinical Studies (14.2)] provide estimates of the probability of reaching a blood pressure goal with irbesartan and hydrochlorothiazide tablets compared to irbesartan or hydrochlorothiazide (HCTZ) monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with irbesartan and hydrochlorothiazide tablets compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b. Figure 1a: Probability of Achieving SBP <140 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*. Figure 1b: Probability of Achieving SBP <130 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*. Figure 2a: Probability of Achieving DBP <90 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*. Figure 2b: Probability of Achieving DBP <80 mmHg in Patients from Initial Therapy Studies V (Week 8) and VI (Week 7)*. * For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis). The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure ≤140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone). The likelihood of achieving these goals on irbesartan and hydrochlorothiazide tablets rises to about 40% (systolic) or 70% (diastolic).</IndicationAndUsage>
<Description>Irbesartan and Hydrochlorothiazide Tablets USP are a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, USP and a thiazide diuretic, hydrochlorothiazide (HCTZ), USP. Irbesartan, USP is a non-peptide compound, chemically described as a 2-Butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its structural formula is. C25H28N6O M.W. 428.5. Irbesartan, USP is a white to off-white crystalline powder. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan, USP is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide, USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its structural formula is. C7H8ClN3O4S2 M.W. 297.7. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. Hydrochlorothiazide, USP is very slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan, USP combined with 12.5 mg of hydrochlorothiazide, USP. Inactive ingredients include: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, povidone, pregelatinized corn starch and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>85509-1035-9</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-9) </PackageDescription>
<NDC11Code>85509-1035-09</NDC11Code>
<ProductNDC>85509-1035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091281</ApplicationNumber>
<LabelerName>PHOENIX RX LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. Limitations of Use: 1 Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted., 2 Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride extended-release capsules USP are skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in cyclobenzaprine hydrochloride extended-release capsules is cyclobenzaprine hydrochloride, USP. Cyclobenzaprine hydrochloride (HCl) is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK aof 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride extended-release capsules for oral administration are supplied in 15 and 30 mg strengths. Cyclobenzaprine hydrochloride extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl alcohol, ethylcellulose, FDC yellow #6, gelatin, hydroxypropyl cellulose, isopropyl alcohol, potassium hydroxide, sugar spheres (which contain sucrose and corn starch) and titanium dioxide. In addition, red iron oxide is also included in the 15 mg strength. The capsule is imprinted with black ink consisting of: black iron oxide, DC Yellow #10, ethanol, FDC Blue #1, FDC Blue #2, FDC Red #40, methanol, N-butyl alcohol, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>0121-1035-55</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (0121-1035-55) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00121-1035-55</NDC11Code>
<ProductNDC>0121-1035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lincomycin</ProprietaryName>
<NonProprietaryName>Lincomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20241007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212770</ApplicationNumber>
<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>LINCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3000</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lincomycin Injection sterile solution is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING, before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. The drug may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin Injection and other antibacterial drugs, Lincomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Lincomycin Injection, USP sterile solution contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2- pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C 18H34N 2O 6S●HCl●H 2O and the molecular weight is 461.01. The structural formula is represented below. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. Each mL contains lincomycin hydrochloride equivalent to 300 mg lincomycin. Also contains 9.45 mg benzyl alcohol added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>10191-1035-2</NDCCode>
<PackageDescription>170 PELLET in 1 VIAL, GLASS (10191-1035-2) </PackageDescription>
<NDC11Code>10191-1035-02</NDC11Code>
<ProductNDC>10191-1035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Codeinum</ProprietaryName>
<NonProprietaryName>Codeine</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20150714</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Remedy Makers</LabelerName>
<SubstanceName>CODEINE ANHYDROUS</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VERTIGO, DIARRHEA, PAIN OR OTHER INDICATIONS.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43742-1035-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-1035-1) </PackageDescription>
<NDC11Code>43742-1035-01</NDC11Code>
<ProductNDC>43742-1035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bio Lymph Phase</ProprietaryName>
<NonProprietaryName>Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (smilax Regelii), Ascorbicum Acidum, Quercetin, Myosotis Arvensis, Calcarea Phosphorica, Ferrum Iodatum, Thyroidinum (suis), Gaertner Bacillus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170720</StartMarketingDate>
<EndMarketingDate>20240723</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>ARANEUS DIADEMATUS; ASCORBIC ACID; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; PINUS SYLVESTRIS LEAFY TWIG; QUERCETIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SCROPHULARIA NODOSA; SMILAX ORNATA ROOT; SODIUM SULFATE; SUS SCROFA THYROID; TEUCRIUM SCORODONIA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; VERONICA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>6; 6; 4; 12; 4; 5; 4; 5; 5; 9; 4; 4; 6; 30; 3; 6; 4; 12; 3; 12; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170720</StartMarketingDatePackage>
<EndMarketingDatePackage>20240723</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of swelling due to minor injury.**. **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70121-1035-5</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1035-5) / 2 mL in 1 VIAL, SINGLE-DOSE (70121-1035-1) </PackageDescription>
<NDC11Code>70121-1035-05</NDC11Code>
<ProductNDC>70121-1035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paricalcitol</ProprietaryName>
<NonProprietaryName>Paricalcitol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206699</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PARICALCITOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Vitamin D Analog [EPC], Vitamin D2 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
<Description>Paricalcitol, USP is a synthetically manufactured active vitamin D analog. It is a white to almost white powder chemically designated as (1α,3β,7E,22E)-19-Nor-9,10-secoergosta-5,7,22-triene-1,3,25-triol and has the following structural formula. Molecular formula is C27H44O3. Molecular weight is 416.64 g/mol. Paricalcitol injection, USP is a sterile, aqueous solution for intravenous use. Each mL contains paricalcitol USP, 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 20% (v/v) and propylene glycol, 30% (v/v).</Description>
</NDC>
<NDC>
<NDCCode>70121-1035-7</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1035-7) / 2 mL in 1 VIAL, SINGLE-DOSE (70121-1035-1) </PackageDescription>
<NDC11Code>70121-1035-07</NDC11Code>
<ProductNDC>70121-1035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paricalcitol</ProprietaryName>
<NonProprietaryName>Paricalcitol</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206699</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PARICALCITOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Vitamin D Analog [EPC], Vitamin D2 Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
<Description>Paricalcitol, USP is a synthetically manufactured active vitamin D analog. It is a white to almost white powder chemically designated as (1α,3β,7E,22E)-19-Nor-9,10-secoergosta-5,7,22-triene-1,3,25-triol and has the following structural formula. Molecular formula is C27H44O3. Molecular weight is 416.64 g/mol. Paricalcitol injection, USP is a sterile, aqueous solution for intravenous use. Each mL contains paricalcitol USP, 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 20% (v/v) and propylene glycol, 30% (v/v).</Description>
</NDC>
<NDC>
<NDCCode>85509-1035-3</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-3) </PackageDescription>
<NDC11Code>85509-1035-03</NDC11Code>
<ProductNDC>85509-1035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091281</ApplicationNumber>
<LabelerName>PHOENIX RX LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. Limitations of Use: 1 Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted., 2 Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride extended-release capsules USP are skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in cyclobenzaprine hydrochloride extended-release capsules is cyclobenzaprine hydrochloride, USP. Cyclobenzaprine hydrochloride (HCl) is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK aof 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride extended-release capsules for oral administration are supplied in 15 and 30 mg strengths. Cyclobenzaprine hydrochloride extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl alcohol, ethylcellulose, FDC yellow #6, gelatin, hydroxypropyl cellulose, isopropyl alcohol, potassium hydroxide, sugar spheres (which contain sucrose and corn starch) and titanium dioxide. In addition, red iron oxide is also included in the 15 mg strength. The capsule is imprinted with black ink consisting of: black iron oxide, DC Yellow #10, ethanol, FDC Blue #1, FDC Blue #2, FDC Red #40, methanol, N-butyl alcohol, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>85509-1035-6</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-6) </PackageDescription>
<NDC11Code>85509-1035-06</NDC11Code>
<ProductNDC>85509-1035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091281</ApplicationNumber>
<LabelerName>PHOENIX RX LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. Limitations of Use: 1 Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted., 2 Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride extended-release capsules USP are skeletal muscle relaxant which relieves muscle spasm of local origin without interfering with muscle function. The active ingredient in cyclobenzaprine hydrochloride extended-release capsules is cyclobenzaprine hydrochloride, USP. Cyclobenzaprine hydrochloride (HCl) is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK aof 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-( 5H-dibenzo[ a,d] cyclohepten-5-ylidene)- N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride extended-release capsules for oral administration are supplied in 15 and 30 mg strengths. Cyclobenzaprine hydrochloride extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl alcohol, ethylcellulose, FDC yellow #6, gelatin, hydroxypropyl cellulose, isopropyl alcohol, potassium hydroxide, sugar spheres (which contain sucrose and corn starch) and titanium dioxide. In addition, red iron oxide is also included in the 15 mg strength. The capsule is imprinted with black ink consisting of: black iron oxide, DC Yellow #10, ethanol, FDC Blue #1, FDC Blue #2, FDC Red #40, methanol, N-butyl alcohol, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>70771-1012-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (70771-1012-9) </PackageDescription>
<NDC11Code>70771-1012-09</NDC11Code>
<ProductNDC>70771-1012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208961</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1013-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (70771-1013-9) </PackageDescription>
<NDC11Code>70771-1013-09</NDC11Code>
<ProductNDC>70771-1013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208961</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1014-9</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (70771-1014-9) </PackageDescription>
<NDC11Code>70771-1014-09</NDC11Code>
<ProductNDC>70771-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clomipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clomipramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208961</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>CLOMIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1015-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70771-1015-9) </PackageDescription>
<NDC11Code>70771-1015-09</NDC11Code>
<ProductNDC>70771-1015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nateglinide</ProprietaryName>
<NonProprietaryName>Nateglinide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205248</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>NATEGLINIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glinide [EPC], Potassium Channel Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1016-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70771-1016-9) </PackageDescription>
<NDC11Code>70771-1016-09</NDC11Code>
<ProductNDC>70771-1016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nateglinide</ProprietaryName>
<NonProprietaryName>Nateglinide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205248</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>NATEGLINIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glinide [EPC], Potassium Channel Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1019-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70771-1019-9) </PackageDescription>
<NDC11Code>70771-1019-09</NDC11Code>
<ProductNDC>70771-1019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Entecavir</ProprietaryName>
<NonProprietaryName>Entecavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206745</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>ENTECAVIR</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1020-9</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70771-1020-9) </PackageDescription>
<NDC11Code>70771-1020-09</NDC11Code>
<ProductNDC>70771-1020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Entecavir</ProprietaryName>
<NonProprietaryName>Entecavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206745</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>ENTECAVIR</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1021-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (70771-1021-9) </PackageDescription>
<NDC11Code>70771-1021-09</NDC11Code>
<ProductNDC>70771-1021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202456</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1022-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (70771-1022-9) </PackageDescription>
<NDC11Code>70771-1022-09</NDC11Code>
<ProductNDC>70771-1022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202456</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1023-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (70771-1023-9) </PackageDescription>
<NDC11Code>70771-1023-09</NDC11Code>
<ProductNDC>70771-1023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202456</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70771-1024-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (70771-1024-9) </PackageDescription>
<NDC11Code>70771-1024-09</NDC11Code>
<ProductNDC>70771-1024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202900</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as scored tablets. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>70771-1025-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (70771-1025-9) </PackageDescription>
<NDC11Code>70771-1025-09</NDC11Code>
<ProductNDC>70771-1025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202900</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as scored tablets. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>70771-1026-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (70771-1026-9) </PackageDescription>
<NDC11Code>70771-1026-09</NDC11Code>
<ProductNDC>70771-1026</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202900</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as scored tablets. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula.</Description>
</NDC>
</NDCList>