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 CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 180 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-816
Product ID 46708-816_61b9ca82-7d41-4f49-b4a0-549c9473c447
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218587
Listing Expiration 2026-12-31
Marketing Start 2024-10-28

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 46708816
Hyphenated Format 46708-816

Supplemental Identifiers

RxCUI
830837 830845 830861
UPC
0346708816315 0346708815318 0346708817312
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 ANDA218587 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-31)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-71)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-91)
source: ndc

Packages (3)

46708-816-31 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-31) 46708-816-71 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-71) 46708-816-91 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-91)

Ingredients (1)

diltiazem hydrochloride (180 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": "61b9ca82-7d41-4f49-b4a0-549c9473c447", "openfda": {"upc": ["0346708816315", "0346708815318", "0346708817312"], "unii": ["OLH94387TE"], "rxcui": ["830837", "830845", "830861"], "spl_set_id": ["61b9ca82-7d41-4f49-b4a0-549c9473c447"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-31)", "package_ndc": "46708-816-31", "marketing_start_date": "20241028"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-71)", "package_ndc": "46708-816-71", "marketing_start_date": "20241028"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-816-91)", "package_ndc": "46708-816-91", "marketing_start_date": "20241028"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "46708-816_61b9ca82-7d41-4f49-b4a0-549c9473c447", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "46708-816", "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": "180 mg/1"}], "application_number": "ANDA218587", "marketing_category": "ANDA", "marketing_start_date": "20241028", "listing_expiration_date": "20261231"}