diltiazem hydrochloride (25021-319)

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride

Generic Name diltiazem hydrochloride

Labeler sagent pharmaceuticals

Dosage Form INJECTION, SOLUTION

Routes

INTRAVENOUS

Active Ingredients

diltiazem hydrochloride 5 mg/mL

Manufacturer

Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-319

Product ID 25021-319_13a2c20f-bf6f-4dad-938e-6f4ff99a689a

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 25021319

Hyphenated Format 25021-319

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 ANDA074617 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

5 mg/mL

source: ndc

Packaging

10 VIAL in 1 CARTON (25021-319-05) / 5 mL in 1 VIAL
10 VIAL in 1 CARTON (25021-319-10) / 10 mL in 1 VIAL
10 VIAL in 1 CARTON (25021-319-25) / 25 mL in 1 VIAL

source: ndc

Packages (3)

25021-319-05 10 VIAL in 1 CARTON (25021-319-05) / 5 mL in 1 VIAL 25021-319-10 10 VIAL in 1 CARTON (25021-319-10) / 10 mL in 1 VIAL 25021-319-25 10 VIAL in 1 CARTON (25021-319-25) / 25 mL in 1 VIAL

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": "13a2c20f-bf6f-4dad-938e-6f4ff99a689a", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["1791229", "1791232", "1791233"], "spl_set_id": ["9d51c0f6-26b7-4220-83fb-4e736b289e64"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-319-05)  / 5 mL in 1 VIAL", "package_ndc": "25021-319-05", "marketing_start_date": "20240601"}, {"sample": false, "description": "10 VIAL in 1 CARTON (25021-319-10)  / 10 mL in 1 VIAL", "package_ndc": "25021-319-10", "marketing_start_date": "20240601"}, {"sample": false, "description": "10 VIAL in 1 CARTON (25021-319-25)  / 25 mL in 1 VIAL", "package_ndc": "25021-319-25", "marketing_start_date": "20240601"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "25021-319_13a2c20f-bf6f-4dad-938e-6f4ff99a689a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "25021-319", "generic_name": "diltiazem hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "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"}