NDC 0145-0091

SORIATANE

Acitretin

SORIATANE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Stiefel Laboratories Inc. The primary component is Acitretin.

• Product ID: 0145-0091_362d9712-c25c-4ae3-9fba-358bc02d5062
• NDC: 0145-0091
• Product Type: Human Prescription Drug
• Proprietary Name: SORIATANE
• Generic Name: Acitretin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1996-11-01
• Marketing Category: NDA / NDA
• Application Number: NDA019821
• Labeler Name: Stiefel Laboratories Inc
• Substance Name: ACITRETIN
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0145-0091-25

30 CAPSULE in 1 BOTTLE (0145-0091-25)

• Marketing Start Date: 1996-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0145-0091-25 [00145009125]

SORIATANE CAPSULE

• Marketing Category: NDA
• Application Number: NDA019821
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1996-11-01

Drug Details

Active Ingredients

Ingredient	Strength
ACITRETIN	25 mg/1

OpenFDA Data

• SPL SET ID: cec7851f-c7af-4e9e-a5e4-a585c70510d2
• Manufacturer:
  • Stiefel Laboratories Inc
• UNII:
  • LCH760E9T7
• RxNorm Concept Unique ID - RxCUI:
  • 199689
  • 213070
  • 199690
  • 213069

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]

NDC Crossover Matching brand name "SORIATANE" or generic name "Acitretin"

NDC	Brand Name	Generic Name
0145-0090	SORIATANE	acitretin
0145-0091	SORIATANE	acitretin
0093-1135	Acitretin	Acitretin
0093-1136	Acitretin	Acitretin
0093-1138	Acitretin	Acitretin
0115-1667	Acitretin	Acitretin
0115-1668	Acitretin	Acitretin
0115-1669	Acitretin	Acitretin
0115-1698	Acitretin	Acitretin
0115-1750	Acitretin	Acitretin
0115-1751	Acitretin	Acitretin
0115-1752	Acitretin	Acitretin
0115-1753	Acitretin	Acitretin