diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: sciegen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler sciegen pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 120 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-495
Product ID 50228-495_2fc25445-56c7-4c39-ac18-32cc1023e7c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216327
Listing Expiration 2026-12-31
Marketing Start 2023-04-06

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 50228495
Hyphenated Format 50228-495

Supplemental Identifiers

RxCUI
830874 830877 830879 830882 830897 830900
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 ANDA216327 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-495-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-495-30)
source: ndc

Packages (2)

50228-495-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-495-05) 50228-495-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-495-30)

Ingredients (1)

diltiazem hydrochloride (120 mg/1)

Linked Drug Pages (1)

DILTIAZEM HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2fc25445-56c7-4c39-ac18-32cc1023e7c2", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830874", "830877", "830879", "830882", "830897", "830900"], "spl_set_id": ["1ca03c9e-edc8-4c7f-89ee-f2346ea8c067"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-495-05)", "package_ndc": "50228-495-05", "marketing_start_date": "20230406"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50228-495-30)", "package_ndc": "50228-495-30", "marketing_start_date": "20230406"}], "brand_name": "DILTIAZEM HYDROCHLORIDE", "product_id": "50228-495_2fc25445-56c7-4c39-ac18-32cc1023e7c2", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "50228-495", "generic_name": "diltiazem hydrochloride", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DILTIAZEM HYDROCHLORIDE", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA216327", "marketing_category": "ANDA", "marketing_start_date": "20230406", "listing_expiration_date": "20261231"}