diltiazem hydrochloride

Generic: diltiazem hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diltiazem hydrochloride
Generic Name diltiazem hydrochloride
Labeler major pharmaceuticals
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diltiazem hydrochloride 240 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7219
Product ID 0904-7219_ef66f466-b51f-4f29-b7a0-f8acc80d3562
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205231
Listing Expiration 2027-12-31
Marketing Start 2022-08-09

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 09047219
Hyphenated Format 0904-7219

Supplemental Identifiers

RxCUI
830801 830837 830845 830861
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 ANDA205231 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7219-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7219-61 100 BLISTER PACK in 1 CARTON (0904-7219-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

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": "ef66f466-b51f-4f29-b7a0-f8acc80d3562", "openfda": {"unii": ["OLH94387TE"], "rxcui": ["830801", "830837", "830845", "830861"], "spl_set_id": ["e7476adc-a940-4e76-a1dd-c418de493bc0"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7219-61)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-7219-61", "marketing_start_date": "20220809"}], "brand_name": "Diltiazem Hydrochloride", "product_id": "0904-7219_ef66f466-b51f-4f29-b7a0-f8acc80d3562", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "0904-7219", "generic_name": "Diltiazem hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diltiazem Hydrochloride", "active_ingredients": [{"name": "DILTIAZEM HYDROCHLORIDE", "strength": "240 mg/1"}], "application_number": "ANDA205231", "marketing_category": "ANDA", "marketing_start_date": "20220809", "listing_expiration_date": "20271231"}