diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler upsher-smith laboratories, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 120 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-026
Product ID 24979-026_016ac187-9c91-4386-ac8c-09555be1baeb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205231
Listing Expiration 2027-12-31
Marketing Start 2018-10-01

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 24979026
Hyphenated Format 24979-026

Supplemental Identifiers

RxCUI
830795 830801 830837 830845 830861
UPC
0324979028064 0324979027067 0324979030074 0324979029061 0324979026060
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 ANDA205231 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 42000 CAPSULE, EXTENDED RELEASE in 1 DRUM (24979-026-00)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-02)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-06)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-07)
source: ndc

Packages (4)

24979-026-00 42000 CAPSULE, EXTENDED RELEASE in 1 DRUM (24979-026-00) 24979-026-02 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-02) 24979-026-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-06) 24979-026-07 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-07)

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": "016ac187-9c91-4386-ac8c-09555be1baeb", "openfda": {"upc": ["0324979028064", "0324979027067", "0324979030074", "0324979029061", "0324979026060"], "unii": ["OLH94387TE"], "rxcui": ["830795", "830801", "830837", "830845", "830861"], "spl_set_id": ["bb32d681-9a83-431e-9984-a5cee2c94852"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "42000 CAPSULE, EXTENDED RELEASE in 1 DRUM (24979-026-00)", "package_ndc": "24979-026-00", "marketing_start_date": "20240701"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-02)", "package_ndc": "24979-026-02", "marketing_start_date": "20181001"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-06)", "package_ndc": "24979-026-06", "marketing_start_date": "20181001"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-07)", "package_ndc": "24979-026-07", "marketing_start_date": "20181001"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "24979-026_016ac187-9c91-4386-ac8c-09555be1baeb", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "24979-026", "generic_name": "Diltiazem hydrochloride", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA205231", "marketing_category": "ANDA", "marketing_start_date": "20181001", "listing_expiration_date": "20271231"}