diltiazem hci

Generic: diltiazem hci

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hci
Generic Name diltiazem hci
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

diltiazem hydrochloride 5 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1335
Product ID 51662-1335_f2a0ac76-9d93-eaad-e053-2a95a90a4d67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078538
Listing Expiration 2026-12-31
Marketing Start 2018-12-21

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621335
Hyphenated Format 51662-1335

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 hci (source: ndc)
Generic Name diltiazem hci (source: ndc)
Application Number ANDA078538 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 mL in 1 VIAL (51662-1335-1)
  • 1 VIAL in 1 POUCH (51662-1335-2) / 5 mL in 1 VIAL
source: ndc

Packages (2)

51662-1335-1 5 mL in 1 VIAL (51662-1335-1) 51662-1335-2 1 VIAL in 1 POUCH (51662-1335-2) / 5 mL in 1 VIAL

Ingredients (1)

diltiazem hydrochloride (5 mg/mL)

Linked Drug Pages (1)

DILTIAZEM HCI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f2a0ac76-9d93-eaad-e053-2a95a90a4d67", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["1791229"], "spl_set_id": ["7d8e8b1e-f67b-57d2-e053-2991aa0a8d12"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL (51662-1335-1)", "package_ndc": "51662-1335-1", "marketing_start_date": "20181221"}, {"sample": false, "description": "1 VIAL in 1 POUCH (51662-1335-2)  / 5 mL in 1 VIAL", "package_ndc": "51662-1335-2", "marketing_start_date": "20230119"}], "brand_name": "DILTIAZEM HCI", "product_id": "51662-1335_f2a0ac76-9d93-eaad-e053-2a95a90a4d67", "dosage_form": "INJECTION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]"], "product_ndc": "51662-1335", "generic_name": "DILTIAZEM HCI", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DILTIAZEM HCI", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA078538", "marketing_category": "ANDA", "marketing_start_date": "20181221", "listing_expiration_date": "20261231"}