diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

diltiazem hydrochloride 5 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-319
Product ID 84549-319_3f2942d7-f4d1-2d77-e063-6294a90a74ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074617
Listing Expiration 2026-12-31
Marketing Start 2024-06-01

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 84549319
Hyphenated Format 84549-319

Supplemental Identifiers

RxCUI
1791229
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 ANDA074617 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 mL in 1 VIAL (84549-319-05)
source: ndc

Packages (1)

84549-319-05 5 mL in 1 VIAL (84549-319-05)

Ingredients (1)

diltiazem hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Diltiazem Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3f2942d7-f4d1-2d77-e063-6294a90a74ad", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["1791229"], "spl_set_id": ["3f2942d7-f4d0-2d77-e063-6294a90a74ad"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL (84549-319-05)", "package_ndc": "84549-319-05", "marketing_start_date": "20250918"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "84549-319_3f2942d7-f4d1-2d77-e063-6294a90a74ad", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "84549-319", "generic_name": "diltiazem hydrochloride", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA074617", "marketing_category": "ANDA", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}