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, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

diltiazem hydrochloride 100 mg/1

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1457
Product ID 51662-1457_132cd9f9-a36c-4e35-e063-6294a90aaa17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075853
Listing Expiration 2026-12-31
Marketing Start 2019-12-15

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 516621457
Hyphenated Format 51662-1457

Supplemental Identifiers

RxCUI
1791240
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 ANDA075853 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (51662-1457-1)
  • 10 POUCH in 1 CASE (51662-1457-3) / 1 VIAL, PATENT DELIVERY SYSTEM in 1 POUCH (51662-1457-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM
source: ndc

Packages (2)

51662-1457-1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (51662-1457-1) 51662-1457-3 10 POUCH in 1 CASE (51662-1457-3) / 1 VIAL, PATENT DELIVERY SYSTEM in 1 POUCH (51662-1457-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM

Ingredients (1)

diltiazem hydrochloride (100 mg/1)

Linked Drug Pages (1)

DILTIAZEM HCI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "132cd9f9-a36c-4e35-e063-6294a90aaa17", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["1791240"], "spl_set_id": ["99c5813f-1ffe-0eaa-e053-2a95a90a751b"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (51662-1457-1)", "package_ndc": "51662-1457-1", "marketing_start_date": "20191215"}, {"sample": false, "description": "10 POUCH in 1 CASE (51662-1457-3)  / 1 VIAL, PATENT DELIVERY SYSTEM in 1 POUCH (51662-1457-2)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM", "package_ndc": "51662-1457-3", "marketing_start_date": "20221211"}], "brand_name": "DILTIAZEM HCI", "product_id": "51662-1457_132cd9f9-a36c-4e35-e063-6294a90aaa17", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "51662-1457", "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": "100 mg/1"}], "application_number": "ANDA075853", "marketing_category": "ANDA", "marketing_start_date": "20191215", "listing_expiration_date": "20261231"}