diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 120 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-769
Product ID 63187-769_8cfc7ee8-ec1c-478b-bd90-6778f9c3fb98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074185
Listing Expiration 2026-12-31
Marketing Start 1995-12-26

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 63187769
Hyphenated Format 63187-769

Supplemental Identifiers

RxCUI
831054
UPC
0363187769307
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 hydrochloride (source: ndc)
Generic Name diltiazem hydrochloride (source: ndc)
Application Number ANDA074185 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (63187-769-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-769-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-769-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-769-90)
source: ndc

Packages (4)

63187-769-10 10 TABLET, FILM COATED in 1 BOTTLE (63187-769-10) 63187-769-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-769-30) 63187-769-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-769-60) 63187-769-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-769-90)

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": "8cfc7ee8-ec1c-478b-bd90-6778f9c3fb98", "openfda": {"upc": ["0363187769307"], "unii": ["OLH94387TE"], "rxcui": ["831054"], "spl_set_id": ["a24255a3-88b1-47ef-90fc-51619a1c5a63"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (63187-769-10)", "package_ndc": "63187-769-10", "marketing_start_date": "20161101"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-769-30)", "package_ndc": "63187-769-30", "marketing_start_date": "20161101"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-769-60)", "package_ndc": "63187-769-60", "marketing_start_date": "20161101"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-769-90)", "package_ndc": "63187-769-90", "marketing_start_date": "20230524"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "63187-769_8cfc7ee8-ec1c-478b-bd90-6778f9c3fb98", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "63187-769", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA074185", "marketing_category": "ANDA", "marketing_start_date": "19951226", "listing_expiration_date": "20261231"}