diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: cipla usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler cipla usa, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 300 mg/1

Manufacturer
Cipla USA, Inc.

Identifiers & Regulatory

Product NDC 69097-995
Product ID 69097-995_8e10fac2-bb4b-4d93-ad8c-4fd93278a91e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216327
Listing Expiration 2026-12-31
Marketing Start 2023-06-12

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 69097995
Hyphenated Format 69097-995

Supplemental Identifiers

RxCUI
830874 830877 830879 830882 830897 830900
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 ANDA216327 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-995-02)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-995-05)
source: ndc

Packages (2)

69097-995-02 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-995-02) 69097-995-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-995-05)

Ingredients (1)

diltiazem hydrochloride (300 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": "8e10fac2-bb4b-4d93-ad8c-4fd93278a91e", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830874", "830877", "830879", "830882", "830897", "830900"], "spl_set_id": ["bce61158-201d-458c-be0c-9bdd2d3a0bec"], "manufacturer_name": ["Cipla USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-995-02)", "package_ndc": "69097-995-02", "marketing_start_date": "20230612"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-995-05)", "package_ndc": "69097-995-05", "marketing_start_date": "20230612"}], "brand_name": "DILTIAZEM HYDROCHLORIDE", "product_id": "69097-995_8e10fac2-bb4b-4d93-ad8c-4fd93278a91e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "69097-995", "generic_name": "diltiazem hydrochloride", "labeler_name": "Cipla USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DILTIAZEM HYDROCHLORIDE", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA216327", "marketing_category": "ANDA", "marketing_start_date": "20230612", "listing_expiration_date": "20261231"}