diltiazem hydrochloride

Generic: diltiazem hydrochloride

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

Drug Facts

Product Profile

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

diltiazem hydrochloride 120 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1389
Product ID 71335-1389_41f11f00-de3c-4224-94f7-0836f7c821a4
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 713351389
Hyphenated Format 71335-1389

Supplemental Identifiers

RxCUI
830837 830845 830861
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
  • 120 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1389-1)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1389-2)
source: ndc

Packages (2)

71335-1389-1 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1389-1) 71335-1389-2 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1389-2)

Ingredients (1)

diltiazem hydrochloride (120 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": "41f11f00-de3c-4224-94f7-0836f7c821a4", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830837", "830845", "830861"], "spl_set_id": ["c1ef9e90-6ff0-4ee5-86a3-1efee9c36789"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1389-1)", "package_ndc": "71335-1389-1", "marketing_start_date": "20191118"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1389-2)", "package_ndc": "71335-1389-2", "marketing_start_date": "20191118"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "71335-1389_41f11f00-de3c-4224-94f7-0836f7c821a4", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "71335-1389", "generic_name": "Diltiazem hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA075116", "marketing_category": "ANDA", "marketing_start_date": "19991228", "listing_expiration_date": "20261231"}