Diltiazem Hydrochloride Extended-Release

Generic: Diltiazem Hydrochloride

Labeler: Mayne Pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Diltiazem Hydrochloride Extended-Release
Generic Name Diltiazem Hydrochloride
Labeler Mayne Pharma
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

DILTIAZEM HYDROCHLORIDE 120 mg/1

Identifiers & Regulatory

Product NDC 51862-330
Product ID 51862-330_47a91f1d-38c9-37bf-e063-6394a90accb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215775
Marketing Start 2023-01-30
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862330
Hyphenated Format 51862-330

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 Extended-Release (source: ndc)
Generic Name Diltiazem Hydrochloride (source: ndc)
Application Number ANDA215775 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51862-330-01)
source: ndc

Packages (1)

51862-330-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51862-330-01)

Ingredients (1)

DILTIAZEM HYDROCHLORIDE (120 mg/1)

Linked Drug Pages (1)

Diltiazem Hydrochloride Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47a91f1d-38c9-37bf-e063-6394a90accb6", "openfda": {"upc": ["0351862329014", "0351862330010", "0351862328017"], "unii": ["OLH94387TE"], "rxcui": ["830865", "830869", "830872"], "spl_set_id": ["079f5bf1-4d13-4060-af88-f2301dde0ba1"], "manufacturer_name": ["Mayne Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51862-330-01)", "package_ndc": "51862-330-01", "marketing_end_date": "20260228", "marketing_start_date": "20230130"}], "brand_name": "Diltiazem Hydrochloride Extended-Release", "product_id": "51862-330_47a91f1d-38c9-37bf-e063-6394a90accb6", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "51862-330", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Mayne Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride Extended-Release", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA215775", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20230130"}