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
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 120 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 50228-484
Product ID 50228-484_31a9f85e-b3f0-4b39-a133-8d4324df2aff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216521
Listing Expiration 2026-12-31
Marketing Start 2022-09-26

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 50228484
Hyphenated Format 50228-484

Supplemental Identifiers

RxCUI
831054 831102 831103 833217
UPC
0350228484015 0350228481052 0350228484053 0350228482059 0350228483018 0350228482011 0350228483056 0350228481014
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 ANDA216521 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50228-484-01)
  • 500 TABLET in 1 BOTTLE (50228-484-05)
  • 30 TABLET in 1 BOTTLE (50228-484-30)
source: ndc

Packages (3)

50228-484-01 100 TABLET in 1 BOTTLE (50228-484-01) 50228-484-05 500 TABLET in 1 BOTTLE (50228-484-05) 50228-484-30 30 TABLET in 1 BOTTLE (50228-484-30)

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": "31a9f85e-b3f0-4b39-a133-8d4324df2aff", "openfda": {"upc": ["0350228484015", "0350228481052", "0350228484053", "0350228482059", "0350228483018", "0350228482011", "0350228483056", "0350228481014"], "unii": ["OLH94387TE"], "rxcui": ["831054", "831102", "831103", "833217"], "spl_set_id": ["196fc367-330e-4d15-b1d6-084ad3f97ae7"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50228-484-01)", "package_ndc": "50228-484-01", "marketing_start_date": "20220926"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (50228-484-05)", "package_ndc": "50228-484-05", "marketing_start_date": "20220926"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-484-30)", "package_ndc": "50228-484-30", "marketing_start_date": "20220926"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "50228-484_31a9f85e-b3f0-4b39-a133-8d4324df2aff", "dosage_form": "TABLET", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "50228-484", "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": "ANDA216521", "marketing_category": "ANDA", "marketing_start_date": "20220926", "listing_expiration_date": "20261231"}