diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 60 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-782
Product ID 46708-782_74bab197-f719-48c0-ac84-c0cf0087b45a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217633
Listing Expiration 2026-12-31
Marketing Start 2025-11-14

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 46708782
Hyphenated Format 46708-782

Supplemental Identifiers

RxCUI
831054 831102 831103 833217
UPC
0346708783310 0346708784317
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 ANDA217633 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-782-31)
  • 500 TABLET, FILM COATED in 1 BOTTLE (46708-782-71)
source: ndc

Packages (2)

46708-782-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-782-31) 46708-782-71 500 TABLET, FILM COATED in 1 BOTTLE (46708-782-71)

Ingredients (1)

diltiazem hydrochloride (60 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": "74bab197-f719-48c0-ac84-c0cf0087b45a", "openfda": {"upc": ["0346708783310", "0346708784317"], "unii": ["OLH94387TE"], "rxcui": ["831054", "831102", "831103", "833217"], "spl_set_id": ["74bab197-f719-48c0-ac84-c0cf0087b45a"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (46708-782-31)", "package_ndc": "46708-782-31", "marketing_start_date": "20251114"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (46708-782-71)", "package_ndc": "46708-782-71", "marketing_start_date": "20251114"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "46708-782_74bab197-f719-48c0-ac84-c0cf0087b45a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "46708-782", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA217633", "marketing_category": "ANDA", "marketing_start_date": "20251114", "listing_expiration_date": "20261231"}