posaconazole

Generic: posaconazole

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

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler major pharmaceuticals
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

posaconazole 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7149
Product ID 0904-7149_4edb3354-581c-4395-8a22-adc84d55c494
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213454
Listing Expiration 2026-12-31
Marketing Start 2021-02-03

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047149
Hyphenated Format 0904-7149

Supplemental Identifiers

RxCUI
1482908
UNII
6TK1G07BHZ
NUI
N0000175487 M0002083

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 posaconazole (source: ndc)
Generic Name posaconazole (source: ndc)
Application Number ANDA213454 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-7149-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 20 BLISTER PACK in 1 CARTON (0904-7149-10) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

0904-7149-04 30 BLISTER PACK in 1 CARTON (0904-7149-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 0904-7149-10 20 BLISTER PACK in 1 CARTON (0904-7149-10) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

posaconazole (100 mg/1)

Linked Drug Pages (1)

POSACONAZOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4edb3354-581c-4395-8a22-adc84d55c494", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["6TK1G07BHZ"], "rxcui": ["1482908"], "spl_set_id": ["8e1e69b8-cf41-47cc-a3ec-1baee55f099a"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7149-04)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-7149-04", "marketing_start_date": "20210203"}, {"sample": false, "description": "20 BLISTER PACK in 1 CARTON (0904-7149-10)  / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-7149-10", "marketing_start_date": "20210203"}], "brand_name": "POSACONAZOLE", "product_id": "0904-7149_4edb3354-581c-4395-8a22-adc84d55c494", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0904-7149", "generic_name": "POSACONAZOLE", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "POSACONAZOLE", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA213454", "marketing_category": "ANDA", "marketing_start_date": "20210203", "listing_expiration_date": "20261231"}