DILTIAZEM HYDROCHLORIDE tablet
Drug Labeling and Warnings
Drug Details [pdf]
- SPL UNCLASSIFIED
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 70771-1929-1 in bottles of 100 tablets
Diltiazem hydrochloride tablets USP, 30 mg
100 Tablets
Rx Only
NDC: 70771-1930-1 in bottles of 100 tablets
Diltiazem hydrochloride tablets USP, 60 mg
100 Tablets
Rx Only
NDC: 70771-1931-1 in bottles of 100 tablets
Diltiazem hydrochloride tablets USP, 90 mg
100 Tablets
Rx Only
NDC: 70771-1932-1 in bottles of 100 tablets
Diltiazem hydrochloride tablets USP, 120 mg
100 Tablets
Rx Only
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INGREDIENTS AND APPEARANCE
DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1929 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H) DILTIAZEM HYDROCHLORIDE 30 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) Product Characteristics Color GREEN Score no score Shape ROUND Size 8mm Flavor Imprint Code 1867 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1929-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2026 2 NDC: 70771-1929-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA219253 05/25/2026 DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1930 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H) DILTIAZEM HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 18;68 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1930-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2026 2 NDC: 70771-1930-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA219253 05/25/2026 DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1931 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H) DILTIAZEM HYDROCHLORIDE 90 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) Product Characteristics Color GREEN Score 2 pieces Shape OVAL (Capsule shaped) Size 17mm Flavor Imprint Code 18;69 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1931-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2026 2 NDC: 70771-1931-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA219253 05/25/2026 DILTIAZEM HYDROCHLORIDE
diltiazem hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 70771-1932 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H) DILTIAZEM HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE Score 2 pieces Shape OVAL (Capsule shaped) Size 19mm Flavor Imprint Code 18;70 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 70771-1932-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2026 2 NDC: 70771-1932-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA219253 05/25/2026 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (677605858) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(70771-1929, 70771-1930, 70771-1931, 70771-1932) , MANUFACTURE(70771-1929, 70771-1930, 70771-1931, 70771-1932)
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