tiazac extended release

Generic: diltiazem hydrochloride

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tiazac extended release
Generic Name diltiazem hydrochloride
Labeler bausch health us, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 180 mg/1

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 0187-2613
Product ID 0187-2613_fe0721cb-5bee-49c5-909b-3c7ea0e2e6c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020401
Listing Expiration 2026-12-31
Marketing Start 2014-08-20

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 01872613
Hyphenated Format 0187-2613

Supplemental Identifiers

RxCUI
830795 830801 830837 830845 830861 831193 831244 831296 831323 831347 831359 831360
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 tiazac extended release (source: ndc)
Generic Name diltiazem hydrochloride (source: ndc)
Application Number NDA020401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2613-30)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2613-90)
source: ndc

Packages (2)

0187-2613-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2613-30) 0187-2613-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2613-90)

Ingredients (1)

diltiazem hydrochloride (180 mg/1)

Linked Drug Pages (1)

TIAZAC EXTENDED RELEASE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fe0721cb-5bee-49c5-909b-3c7ea0e2e6c6", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830795", "830801", "830837", "830845", "830861", "831193", "831244", "831296", "831323", "831347", "831359", "831360"], "spl_set_id": ["c567fe7e-887e-4291-a0d1-2dd3f25cbf25"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2613-30)", "package_ndc": "0187-2613-30", "marketing_start_date": "20140820"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2613-90)", "package_ndc": "0187-2613-90", "marketing_start_date": "20140820"}], "brand_name": "TIAZAC EXTENDED RELEASE", "product_id": "0187-2613_fe0721cb-5bee-49c5-909b-3c7ea0e2e6c6", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "0187-2613", "generic_name": "diltiazem hydrochloride", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TIAZAC", "brand_name_suffix": "EXTENDED RELEASE", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "NDA020401", "marketing_category": "NDA", "marketing_start_date": "20140820", "listing_expiration_date": "20261231"}