diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 300 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-721
Product ID 63304-721_35b4a94c-9d26-e406-e063-6394a90aa9fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203023
Listing Expiration 2026-12-31
Marketing Start 2018-10-31

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 63304721
Hyphenated Format 63304-721

Supplemental Identifiers

RxCUI
830795 830801 830837 830845 830861
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 ANDA203023 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-05)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-30)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-90)
source: ndc

Packages (3)

63304-721-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-05) 63304-721-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-30) 63304-721-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-90)

Ingredients (1)

diltiazem hydrochloride (300 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": "35b4a94c-9d26-e406-e063-6394a90aa9fc", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830795", "830801", "830837", "830845", "830861"], "spl_set_id": ["976d9dd0-4f11-4439-b84e-0c0f0e018d8b"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-05)", "package_ndc": "63304-721-05", "marketing_start_date": "20181031"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-30)", "package_ndc": "63304-721-30", "marketing_start_date": "20181031"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-90)", "package_ndc": "63304-721-90", "marketing_start_date": "20181031"}], "brand_name": "Diltiazem hydrochloride", "product_id": "63304-721_35b4a94c-9d26-e406-e063-6394a90aa9fc", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "63304-721", "generic_name": "Diltiazem hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA203023", "marketing_category": "ANDA", "marketing_start_date": "20181031", "listing_expiration_date": "20261231"}