diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: safecor health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

diltiazem hydrochloride 120 mg/1

Manufacturer
Safecor Health LLC

Identifiers & Regulatory

Product NDC 48433-032
Product ID 48433-032_49eef6c8-e1fc-86af-e063-6294a90a0309
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074910
Listing Expiration 2027-12-31
Marketing Start 2026-02-02

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 48433032
Hyphenated Format 48433-032

Supplemental Identifiers

RxCUI
830865 830869 830872
UNII
OLH94387TE

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 ANDA074910 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (48433-032-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (48433-032-01)
source: ndc

Packages (1)

48433-032-20 100 BLISTER PACK in 1 CARTON (48433-032-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (48433-032-01)

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": "49eef6c8-e1fc-86af-e063-6294a90a0309", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830865", "830869", "830872"], "spl_set_id": ["fc02db0f-5311-4b61-896e-bfe340832735"], "manufacturer_name": ["Safecor Health LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (48433-032-20)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (48433-032-01)", "package_ndc": "48433-032-20", "marketing_start_date": "20260202"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "48433-032_49eef6c8-e1fc-86af-e063-6294a90a0309", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "48433-032", "generic_name": "diltiazem hydrochloride", "labeler_name": "Safecor Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA074910", "marketing_category": "ANDA", "marketing_start_date": "20260202", "listing_expiration_date": "20271231"}