diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 60 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7401
Product ID 50090-7401_a00809e7-b922-47f3-823f-e2fe07d0c260
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216521
Listing Expiration 2026-12-31
Marketing Start 2022-09-26

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907401
Hyphenated Format 50090-7401

Supplemental Identifiers

RxCUI
831103
UNII
OLH94387TE

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diltiazem hydrochloride (source: ndc)
Generic Name diltiazem hydrochloride (source: ndc)
Application Number ANDA216521 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (50090-7401-2)
  • 90 TABLET in 1 BOTTLE (50090-7401-3)
source: ndc

Packages (2)

50090-7401-2 30 TABLET in 1 BOTTLE (50090-7401-2) 50090-7401-3 90 TABLET in 1 BOTTLE (50090-7401-3)

Ingredients (1)

diltiazem hydrochloride (60 mg/1)

Linked Drug Pages (1)

Diltiazem Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a00809e7-b922-47f3-823f-e2fe07d0c260", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["831103"], "spl_set_id": ["88b150a6-4c8d-49c8-88df-f3606c335472"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-7401-2)", "package_ndc": "50090-7401-2", "marketing_start_date": "20241024"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-7401-3)", "package_ndc": "50090-7401-3", "marketing_start_date": "20241024"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "50090-7401_a00809e7-b922-47f3-823f-e2fe07d0c260", "dosage_form": "TABLET", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "50090-7401", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA216521", "marketing_category": "ANDA", "marketing_start_date": "20220926", "listing_expiration_date": "20261231"}