diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diltiazem hydrochloride 60 mg/1

Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-553
Product ID 16714-553_a11626b3-d7a9-43b0-85d4-38a582acd661
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212317
Listing Expiration 2026-12-31
Marketing Start 2022-06-23

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 16714553
Hyphenated Format 16714-553

Supplemental Identifiers

RxCUI
830865 830869 830872
UPC
0316714554013 0316714553016 0316714555010
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 ANDA212317 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-553-01)
source: ndc

Packages (1)

16714-553-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-553-01)

Ingredients (1)

diltiazem hydrochloride (60 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": "a11626b3-d7a9-43b0-85d4-38a582acd661", "openfda": {"upc": ["0316714554013", "0316714553016", "0316714555010"], "unii": ["OLH94387TE"], "rxcui": ["830865", "830869", "830872"], "spl_set_id": ["e2511ffe-5821-4f64-a469-f8ef9618b1b5"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-553-01)", "package_ndc": "16714-553-01", "marketing_start_date": "20220623"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "16714-553_a11626b3-d7a9-43b0-85d4-38a582acd661", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "16714-553", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA212317", "marketing_category": "ANDA", "marketing_start_date": "20220623", "listing_expiration_date": "20261231"}