diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

diltiazem hydrochloride 5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6014
Product ID 0641-6014_fb823cdb-b2d1-4821-ba0e-d1af2cee72c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078538
Listing Expiration 2026-12-31
Marketing Start 2008-12-17

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 06416014
Hyphenated Format 0641-6014

Supplemental Identifiers

RxCUI
1791229 1791232 1791233
UNII
OLH94387TE

Packaging Origin

Original Packager
true

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 ANDA078538 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0641-6014-10) / 10 mL in 1 VIAL (0641-6014-01)
source: ndc

Packages (1)

0641-6014-10 10 VIAL in 1 CARTON (0641-6014-10) / 10 mL in 1 VIAL (0641-6014-01)

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": "fb823cdb-b2d1-4821-ba0e-d1af2cee72c0", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["1791229", "1791232", "1791233"], "spl_set_id": ["453b73bd-c52d-4d72-a0b3-47588e723e0b"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0641-6014-10)  / 10 mL in 1 VIAL (0641-6014-01)", "package_ndc": "0641-6014-10", "marketing_start_date": "20081217"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "0641-6014_fb823cdb-b2d1-4821-ba0e-d1af2cee72c0", "dosage_form": "INJECTION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "0641-6014", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA078538", "marketing_category": "ANDA", "marketing_start_date": "20081217", "listing_expiration_date": "20261231"}