diltiazem hydrochloride

Generic: diltiazem hydrochloride

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

Drug Facts

Product Profile

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

diltiazem hydrochloride 180 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-816
Product ID 62332-816_2cb5f610-f979-488a-9adf-23ba4f81b772
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 62332816
Hyphenated Format 62332-816

Supplemental Identifiers

RxCUI
830837 830845 830861
UPC
0362332816316 0362332815319
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 (62332-816-31)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-71)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-91)
source: ndc

Packages (3)

62332-816-31 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-31) 62332-816-71 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-71) 62332-816-91 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-91)

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": "2cb5f610-f979-488a-9adf-23ba4f81b772", "openfda": {"upc": ["0362332816316", "0362332815319"], "unii": ["OLH94387TE"], "rxcui": ["830837", "830845", "830861"], "spl_set_id": ["04a85be5-f746-418e-8e37-292703f16934"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-31)", "package_ndc": "62332-816-31", "marketing_start_date": "20241028"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-71)", "package_ndc": "62332-816-71", "marketing_start_date": "20241028"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-816-91)", "package_ndc": "62332-816-91", "marketing_start_date": "20241028"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "62332-816_2cb5f610-f979-488a-9adf-23ba4f81b772", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "62332-816", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Alembic Pharmaceuticals Inc.", "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"}