diltiazem hydrochloride

Generic: diltiazem hydrochloride

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

Drug Facts

Product Profile

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

diltiazem hydrochloride 240 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4005
Product ID 68071-4005_1d7a24e6-549e-9297-e063-6394a90a8372
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075116
Listing Expiration 2026-12-31
Marketing Start 1999-12-28

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 680714005
Hyphenated Format 68071-4005

Supplemental Identifiers

RxCUI
830837
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 ANDA075116 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4005-3)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4005-9)
source: ndc

Packages (2)

68071-4005-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4005-3) 68071-4005-9 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4005-9)

Ingredients (1)

diltiazem hydrochloride (240 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": "1d7a24e6-549e-9297-e063-6394a90a8372", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830837"], "spl_set_id": ["54b0b11d-adc0-4afb-e054-00144ff88e88"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4005-3)", "package_ndc": "68071-4005-3", "marketing_start_date": "20170719"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4005-9)", "package_ndc": "68071-4005-9", "marketing_start_date": "20170719"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "68071-4005_1d7a24e6-549e-9297-e063-6394a90a8372", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "68071-4005", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "240 mg/1"}], "application_number": "ANDA075116", "marketing_category": "ANDA", "marketing_start_date": "19991228", "listing_expiration_date": "20261231"}