{"effective_time":"20260501","id":"f63d2c9f-f49a-4b36-b25d-6fbe3ab5577f","openfda":{"application_number":["ANDA219253"],"brand_name":["Diltiazem hydrochloride"],"generic_name":["DILTIAZEM HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"package_ndc":["70771-1929-1","70771-1929-5","70771-1930-1","70771-1930-5","70771-1931-1","70771-1931-5","70771-1932-1","70771-1932-5"],"product_ndc":["70771-1929","70771-1930","70771-1931","70771-1932"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["831054","831102","831103","833217"],"spl_id":["f63d2c9f-f49a-4b36-b25d-6fbe3ab5577f"],"spl_set_id":["8329d0ac-d68c-48d2-9cbc-e1a1b60192d9"],"substance_name":["DILTIAZEM HYDROCHLORIDE"],"unii":["OLH94387TE"]},"package_label_principal_display_panel":["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 30 mg 100s label 60 mg 100s 90 mg 100s 120 mg 100s"],"set_id":"8329d0ac-d68c-48d2-9cbc-e1a1b60192d9","spl_product_data_elements":["Diltiazem hydrochloride Diltiazem hydrochloride DILTIAZEM HYDROCHLORIDE DILTIAZEM LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2208 (100 MPA.S) SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 TALC FD&C BLUE NO. 1 ALUMINUM LAKE D&C YELLOW NO. 10 ALUMINUM LAKE 1867 Diltiazem hydrochloride Diltiazem hydrochloride DILTIAZEM HYDROCHLORIDE DILTIAZEM LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2208 (100 MPA.S) SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 TALC 18;68 Diltiazem hydrochloride Diltiazem hydrochloride DILTIAZEM HYDROCHLORIDE DILTIAZEM LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2208 (100 MPA.S) SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 TALC FD&C BLUE NO. 1 ALUMINUM LAKE D&C YELLOW NO. 10 ALUMINUM LAKE Capsule shaped 18;69 Diltiazem hydrochloride Diltiazem hydrochloride DILTIAZEM HYDROCHLORIDE DILTIAZEM LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2208 (100 MPA.S) SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 TALC Capsule shaped 18;70"],"spl_unclassified_section":["SPL UNCLASSIFIED"],"version":"1"}