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 CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 240 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5452
Product ID 50090-5452_549954b6-c67a-4da6-9127-d031449ef6d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205231
Listing Expiration 2026-12-31
Marketing Start 2018-10-01

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 500905452
Hyphenated Format 50090-5452

Supplemental Identifiers

RxCUI
830837
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 ANDA205231 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5452-0)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5452-1)
source: ndc

Packages (2)

50090-5452-0 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5452-0) 50090-5452-1 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5452-1)

Ingredients (1)

diltiazem hydrochloride (240 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": "549954b6-c67a-4da6-9127-d031449ef6d8", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830837"], "spl_set_id": ["839af3af-4040-4cf4-8d4a-881a053514cc"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5452-0)", "package_ndc": "50090-5452-0", "marketing_start_date": "20210126"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5452-1)", "package_ndc": "50090-5452-1", "marketing_start_date": "20210126"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "50090-5452_549954b6-c67a-4da6-9127-d031449ef6d8", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "50090-5452", "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": "240 mg/1"}], "application_number": "ANDA205231", "marketing_category": "ANDA", "marketing_start_date": "20181001", "listing_expiration_date": "20261231"}