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 TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 180 mg/1

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-196
Product ID 70436-196_44e0c7a1-c1bd-41e2-e063-6294a90a969d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216439
Listing Expiration 2026-12-31
Marketing Start 2023-03-20

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 70436196
Hyphenated Format 70436-196

Supplemental Identifiers

RxCUI
830874 830877 830879 830882 830897 830900
UPC
0370436199068 0370436196067 0370436200047 0370436197064 0370436197040 0370436198047 0370436200061 0370436198061 0370436199044 0370436195046 0370436195060 0370436196043
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 ANDA216439 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-196-04)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-196-06)
source: ndc

Packages (2)

Ingredients (1)

diltiazem hydrochloride (180 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "44e0c7a1-c1bd-41e2-e063-6294a90a969d", "openfda": {"upc": ["0370436199068", "0370436196067", "0370436200047", "0370436197064", "0370436197040", "0370436198047", "0370436200061", "0370436198061", "0370436199044", "0370436195046", "0370436195060", "0370436196043"], "unii": ["OLH94387TE"], "rxcui": ["830874", "830877", "830879", "830882", "830897", "830900"], "spl_set_id": ["f7137458-0db3-7ecd-e053-6394a90a5f95"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-196-04)", "package_ndc": "70436-196-04", "marketing_start_date": "20230320"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70436-196-06)", "package_ndc": "70436-196-06", "marketing_start_date": "20230320"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "70436-196_44e0c7a1-c1bd-41e2-e063-6294a90a969d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "70436-196", "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": "ANDA216439", "marketing_category": "ANDA", "marketing_start_date": "20230320", "listing_expiration_date": "20261231"}