NDC 49884-425

ALISKIREN

Aliskiren

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

• Product ID: 49884-425_c54a494b-ffd9-4502-81bb-96b3e0de7415
• NDC: 49884-425
• Product Type: Human Prescription Drug
• Proprietary Name: ALISKIREN
• Generic Name: Aliskiren
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206665
• Labeler Name: Par Pharmaceutical, Inc.
• Substance Name: ALISKIREN HEMIFUMARATE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Renin Inhibitor [EPC],Renin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 49884-425-11

30 TABLET, FILM COATED in 1 BOTTLE (49884-425-11)

• Marketing Start Date: 2019-03-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49884-425-11 [49884042511]

ALISKIREN TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA206665
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-25

Drug Details

Active Ingredients

Ingredient	Strength
ALISKIREN HEMIFUMARATE	300 mg/1

OpenFDA Data

• SPL SET ID: f3fd2503-25ef-4660-a29a-f62c491e28fb
• Manufacturer:
  • Par Pharmaceutical, Inc.
• UNII:
  • C8A0P8G029
• RxNorm Concept Unique ID - RxCUI:
  • 1011739
  • 1011736
• UPC Code:
  • 0349884424114
  • 0349884425111

Pharmacological Class

• Renin Inhibitor [EPC]
• Renin Inhibitors [MoA]
• Renin Inhibitor [EPC]
• Renin Inhibitors [MoA]

NDC Crossover Matching brand name "ALISKIREN" or generic name "Aliskiren"

NDC	Brand Name	Generic Name
49884-424	ALISKIREN	ALISKIREN
49884-425	ALISKIREN	ALISKIREN
66993-141	Aliskiren	aliskiren hemifumarate
66993-142	Aliskiren	aliskiren hemifumarate