diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler accord healthcare, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 240 mg/1

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-305
Product ID 16729-305_40bc87cb-ff4f-9728-e063-6294a90a9246
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206997
Listing Expiration 2026-12-31
Marketing Start 2020-09-11

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 16729305
Hyphenated Format 16729-305

Supplemental Identifiers

RxCUI
830837 830845 830861
UPC
0316729305105
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 ANDA206997 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-305-01)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-305-16)
source: ndc

Packages (2)

16729-305-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-305-01) 16729-305-16 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-305-16)

Ingredients (1)

diltiazem hydrochloride (240 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": "40bc87cb-ff4f-9728-e063-6294a90a9246", "openfda": {"upc": ["0316729305105"], "unii": ["OLH94387TE"], "rxcui": ["830837", "830845", "830861"], "spl_set_id": ["70293a05-d314-43fa-a2b1-398cfb39edf8"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-305-01)", "package_ndc": "16729-305-01", "marketing_start_date": "20200911"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-305-16)", "package_ndc": "16729-305-16", "marketing_start_date": "20200911"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "16729-305_40bc87cb-ff4f-9728-e063-6294a90a9246", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "16729-305", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "240 mg/1"}], "application_number": "ANDA206997", "marketing_category": "ANDA", "marketing_start_date": "20200911", "listing_expiration_date": "20261231"}