NDC 0254-2045

POSACONAZOLE

Posaconazole

POSACONAZOLE is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical Inc.. The primary component is Posaconazole.

• Product ID: 0254-2045_10458bda-22fd-4175-9d95-c5f3571ad305
• NDC: 0254-2045
• Product Type: Human Prescription Drug
• Proprietary Name: POSACONAZOLE
• Generic Name: Posaconazole
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-30
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA205053
• Labeler Name: Par Pharmaceutical Inc.
• Substance Name: POSACONAZOLE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Azole Antifungal [EPC], Azoles [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0254-2045-02

60 TABLET, COATED in 1 BOTTLE (0254-2045-02)

• Marketing Start Date: 2019-08-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0254-2045-02 [00254204502]

POSACONAZOLE TABLET, COATED

• Marketing Category: NDA authorized generic
• Application Number: NDA205053
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-30

Drug Details

Active Ingredients

Ingredient	Strength
POSACONAZOLE	100 mg/1

OpenFDA Data

• SPL SET ID: e031b632-8e57-4359-87bd-a5da02bdc55f
• Manufacturer:
  • Par Pharmaceutical Inc.
• UNII:
  • 6TK1G07BHZ
• RxNorm Concept Unique ID - RxCUI:
  • 1482908
• UPC Code:
  • 0302542045021

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]

NDC Crossover Matching brand name "POSACONAZOLE" or generic name "Posaconazole"

NDC	Brand Name	Generic Name
0254-2045	POSACONAZOLE	posaconazole
0406-7711	POSACONAZOLE	posaconazole
0527-2133	POSACONAZOLE	Posaconazole
60687-523	Posaconazole	Posaconazole
70748-258	POSACONAZOLE	POSACONAZOLE
0085-1328	NOXAFIL	posaconazole
0085-2224	NOXAFIL	posaconazole
0085-4324	NOXAFIL	posaconazole
0085-4331	NOXAFIL	posaconazole