diltiazem hydrochloride

Generic: diltiazem hydrochloride

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

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 60 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-334
Product ID 62135-334_1b432d9d-b46c-2ee8-e063-6294a90adb54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074093
Listing Expiration 2026-12-31
Marketing Start 1992-11-05

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 62135334
Hyphenated Format 62135-334

Supplemental Identifiers

RxCUI
831054 831102 831103 833217
UPC
0362135334123 0362135336905 0362135335908 0362135333126
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 ANDA074093 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (62135-334-12)
source: ndc

Packages (1)

62135-334-12 120 TABLET in 1 BOTTLE (62135-334-12)

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": "1b432d9d-b46c-2ee8-e063-6294a90adb54", "openfda": {"upc": ["0362135334123", "0362135336905", "0362135335908", "0362135333126"], "unii": ["OLH94387TE"], "rxcui": ["831054", "831102", "831103", "833217"], "spl_set_id": ["51abce7b-e3d1-44b5-bccc-d463150d0bba"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (62135-334-12)", "package_ndc": "62135-334-12", "marketing_start_date": "20240617"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "62135-334_1b432d9d-b46c-2ee8-e063-6294a90adb54", "dosage_form": "TABLET", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "62135-334", "generic_name": "Diltiazem Hydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA074093", "marketing_category": "ANDA", "marketing_start_date": "19921105", "listing_expiration_date": "20261231"}