posaconazole

Generic: posaconazole

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name posaconazole
Generic Name posaconazole
Labeler glenmark pharmaceuticals inc., usa
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

posaconazole 18 mg/mL

Manufacturer
GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-911
Product ID 68462-911_5ad94bba-fba7-4e3e-809c-6e51ad7a5930
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217553
Listing Expiration 2027-12-31
Marketing Start 2024-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462911
Hyphenated Format 68462-911

Supplemental Identifiers

RxCUI
1492043
UPC
0368462911013
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 ANDA217553 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 18 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68462-911-01) / 16.7 mL in 1 VIAL
source: ndc

Packages (1)

68462-911-01 1 VIAL in 1 CARTON (68462-911-01) / 16.7 mL in 1 VIAL

Ingredients (1)

posaconazole (18 mg/mL)

Linked Drug Pages (1)

posaconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5ad94bba-fba7-4e3e-809c-6e51ad7a5930", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0368462911013"], "unii": ["6TK1G07BHZ"], "rxcui": ["1492043"], "spl_set_id": ["91f89a3b-2479-4d05-9997-7b0cfaa496ec"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68462-911-01)  / 16.7 mL in 1 VIAL", "package_ndc": "68462-911-01", "marketing_start_date": "20240701"}], "brand_name": "posaconazole", "product_id": "68462-911_5ad94bba-fba7-4e3e-809c-6e51ad7a5930", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "68462-911", "generic_name": "posaconazole", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "posaconazole", "active_ingredients": [{"name": "POSACONAZOLE", "strength": "18 mg/mL"}], "application_number": "ANDA217553", "marketing_category": "ANDA", "marketing_start_date": "20240701", "listing_expiration_date": "20271231"}