posaconazole

Generic: posaconazole

Labeler: biocon phama inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler biocon phama inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

posaconazole 100 mg/1

Manufacturer
Biocon Phama Inc.

Identifiers & Regulatory

Product NDC 70377-038
Product ID 70377-038_b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214476
Listing Expiration 2026-12-31
Marketing Start 2022-03-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70377038
Hyphenated Format 70377-038

Supplemental Identifiers

RxCUI
1482908
UNII
6TK1G07BHZ
NUI
N0000175487 M0002083

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 posaconazole (source: ndc)
Generic Name posaconazole (source: ndc)
Application Number ANDA214476 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-038-11)
source: ndc

Packages (1)

70377-038-11 60 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-038-11)

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": "b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["6TK1G07BHZ"], "rxcui": ["1482908"], "spl_set_id": ["e0e8023a-3c82-e455-a57b-ccc0206ad156"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Biocon Phama Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (70377-038-11)", "package_ndc": "70377-038-11", "marketing_start_date": "20220308"}], "brand_name": "POSACONAZOLE", "product_id": "70377-038_b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "70377-038", "generic_name": "Posaconazole", "labeler_name": "Biocon Phama Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "POSACONAZOLE", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "100 mg/1"}], "application_number": "ANDA214476", "marketing_category": "ANDA", "marketing_start_date": "20220308", "listing_expiration_date": "20261231"}