diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler ingenus pharmaceuticals, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 300 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-251
Product ID 50742-251_d52d40db-f91a-49ea-ac2f-88a56f429421
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208783
Listing Expiration 2026-12-31
Marketing Start 2019-06-14

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 50742251
Hyphenated Format 50742-251

Supplemental Identifiers

RxCUI
830795 830801 830837 830845 830861
UPC
0350742248308 0350742249305 0350742250301
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 ANDA208783 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-05)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-10)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-30)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-90)
source: ndc

Packages (4)

50742-251-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-05) 50742-251-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-10) 50742-251-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-30) 50742-251-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-90)

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": "d52d40db-f91a-49ea-ac2f-88a56f429421", "openfda": {"upc": ["0350742248308", "0350742249305", "0350742250301"], "unii": ["OLH94387TE"], "rxcui": ["830795", "830801", "830837", "830845", "830861"], "spl_set_id": ["355f560a-8ebb-4661-ad74-2a22f707d7f8"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-05)", "package_ndc": "50742-251-05", "marketing_start_date": "20190614"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-10)", "package_ndc": "50742-251-10", "marketing_start_date": "20190614"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-30)", "package_ndc": "50742-251-30", "marketing_start_date": "20190614"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-90)", "package_ndc": "50742-251-90", "marketing_start_date": "20190614"}], "brand_name": "diltiazem hydrochloride", "product_id": "50742-251_d52d40db-f91a-49ea-ac2f-88a56f429421", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "50742-251", "generic_name": "diltiazem hydrochloride", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "diltiazem hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA208783", "marketing_category": "ANDA", "marketing_start_date": "20190614", "listing_expiration_date": "20261231"}