diltiazem hydrochloride extended-release

Generic: diltiazem hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride extended-release
Generic Name diltiazem hydrochloride
Labeler bryant ranch prepack
Dosage Form CAPSULE, COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 180 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1043
Product ID 71335-1043_a2a8a8dc-2a75-4a77-861b-b3f6aa7a6474
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074984
Listing Expiration 2026-12-31
Marketing Start 2015-10-01

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 713351043
Hyphenated Format 71335-1043

Supplemental Identifiers

RxCUI
830845
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 extended-release (source: ndc)
Generic Name diltiazem hydrochloride (source: ndc)
Application Number ANDA074984 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1043-1)
  • 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1043-2)
source: ndc

Packages (2)

71335-1043-1 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1043-1) 71335-1043-2 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1043-2)

Ingredients (1)

diltiazem hydrochloride (180 mg/1)

Linked Drug Pages (1)

Diltiazem Hydrochloride Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a2a8a8dc-2a75-4a77-861b-b3f6aa7a6474", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830845"], "spl_set_id": ["eed8cfeb-6ec7-4914-b8e0-a5c3d623c9a4"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1043-1)", "package_ndc": "71335-1043-1", "marketing_start_date": "20211220"}, {"sample": false, "description": "90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1043-2)", "package_ndc": "71335-1043-2", "marketing_start_date": "20211220"}], "brand_name": "Diltiazem Hydrochloride Extended-Release", "product_id": "71335-1043_a2a8a8dc-2a75-4a77-861b-b3f6aa7a6474", "dosage_form": "CAPSULE, COATED, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "71335-1043", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA074984", "marketing_category": "ANDA", "marketing_start_date": "20151001", "listing_expiration_date": "20261231"}