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 180 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5466
Product ID 50090-5466_ca8bbf8c-0492-4e1e-ba94-38cba20eb8c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205231
Listing Expiration 2027-12-31
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 500905466
Hyphenated Format 50090-5466

Supplemental Identifiers

RxCUI
830845
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
  • 180 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5466-0)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5466-1)
source: ndc

Packages (2)

50090-5466-0 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5466-0) 50090-5466-1 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5466-1)

Ingredients (1)

diltiazem hydrochloride (180 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": "ca8bbf8c-0492-4e1e-ba94-38cba20eb8c5", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830845"], "spl_set_id": ["465dbab3-f201-4441-8f55-92a843b5134f"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5466-0)", "package_ndc": "50090-5466-0", "marketing_start_date": "20210208"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5466-1)", "package_ndc": "50090-5466-1", "marketing_start_date": "20210208"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "50090-5466_ca8bbf8c-0492-4e1e-ba94-38cba20eb8c5", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "50090-5466", "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": "180 mg/1"}], "application_number": "ANDA205231", "marketing_category": "ANDA", "marketing_start_date": "20181001", "listing_expiration_date": "20271231"}