diltiazem hydrochloride

Generic: diltiazem hydrochloride

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

Drug Facts

Product Profile

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

diltiazem hydrochloride 180 mg/1

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-192
Product ID 70436-192_44e09bea-a55a-1c4c-e063-6394a90a4806
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216304
Listing Expiration 2026-12-31
Marketing Start 2022-09-05

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 70436192
Hyphenated Format 70436-192

Supplemental Identifiers

RxCUI
830837 830845 830861
UPC
0370436192014 0370436193028 0370436192021 0370436193011 0370436191017
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 ANDA216304 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-192-01)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-192-02)
source: ndc

Packages (2)

70436-192-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-192-01) 70436-192-02 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-192-02)

Ingredients (1)

diltiazem hydrochloride (180 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": "44e09bea-a55a-1c4c-e063-6394a90a4806", "openfda": {"upc": ["0370436192014", "0370436193028", "0370436192021", "0370436193011", "0370436191017"], "unii": ["OLH94387TE"], "rxcui": ["830837", "830845", "830861"], "spl_set_id": ["e66665e8-22eb-f5cd-e053-2a95a90a72e4"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-192-01)", "package_ndc": "70436-192-01", "marketing_start_date": "20220905"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-192-02)", "package_ndc": "70436-192-02", "marketing_start_date": "20220905"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "70436-192_44e09bea-a55a-1c4c-e063-6394a90a4806", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "70436-192", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA216304", "marketing_category": "ANDA", "marketing_start_date": "20220905", "listing_expiration_date": "20261231"}