diltiazem hydrochloride extended-release

Generic: diltiazem hydrochloride

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride extended-release
Generic Name diltiazem hydrochloride
Labeler endo usa, inc.
Dosage Form CAPSULE, COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 180 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 10370-830
Product ID 10370-830_0c13ca26-597e-4886-b085-85bc95eb3ceb
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 10370830
Hyphenated Format 10370-830

Supplemental Identifiers

RxCUI
830801 830837 830845 830861
UPC
0310370832058 0310370830092 0310370831099 0310370831051 0310370829096 0310370832119 0310370832096 0310370831112 0310370830115 0310370830054
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 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
  • 500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-05)
  • 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-09)
  • 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-11)
source: ndc

Packages (3)

10370-830-05 500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-05) 10370-830-09 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-09) 10370-830-11 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-11)

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": "0c13ca26-597e-4886-b085-85bc95eb3ceb", "openfda": {"upc": ["0310370832058", "0310370830092", "0310370831099", "0310370831051", "0310370829096", "0310370832119", "0310370832096", "0310370831112", "0310370830115", "0310370830054"], "unii": ["OLH94387TE"], "rxcui": ["830801", "830837", "830845", "830861"], "spl_set_id": ["a66ad880-cdab-435a-a6f2-574cfdfd1ac3"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-05)", "package_ndc": "10370-830-05", "marketing_start_date": "20161212"}, {"sample": false, "description": "90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-09)", "package_ndc": "10370-830-09", "marketing_start_date": "20170112"}, {"sample": false, "description": "30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (10370-830-11)", "package_ndc": "10370-830-11", "marketing_start_date": "20160907"}], "brand_name": "Diltiazem Hydrochloride Extended-Release", "product_id": "10370-830_0c13ca26-597e-4886-b085-85bc95eb3ceb", "dosage_form": "CAPSULE, COATED, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "10370-830", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Endo USA, Inc.", "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"}