NDC 0378-7020

Acitretin

Acitretin

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

• Product ID: 0378-7020_087670dd-f456-4c31-a2ee-f83f59d16fa0
• NDC: 0378-7020
• Product Type: Human Prescription Drug
• Proprietary Name: Acitretin
• Generic Name: Acitretin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2016-03-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202148
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: ACITRETIN
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Retinoid [EPC], Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0378-7020-93

30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7020-93)

• Marketing Start Date: 2016-03-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-7020-93 [00378702093]

Acitretin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA202148
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-03-10

Drug Details

Active Ingredients

Ingredient	Strength
ACITRETIN	10 mg/1

OpenFDA Data

• SPL SET ID: 2150bb0f-551b-4059-a97b-187d3ab22519
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • LCH760E9T7
• RxNorm Concept Unique ID - RxCUI:
  • 199689
  • 199690

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]
• Retinoid [EPC]
• Retinoids [CS]

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

NDC	Brand Name	Generic Name
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
42291-086	ACITRETIN	ACITRETIN
42291-087	ACITRETIN	ACITRETIN
42291-088	ACITRETIN	ACITRETIN
42794-081	ACITRETIN	ACITRETIN
42794-080	ACITRETIN	ACITRETIN
42794-083	ACITRETIN	ACITRETIN
0378-7023	Acitretin	Acitretin
0378-7020	Acitretin	Acitretin
66993-896	ACITRETIN	ACITRETIN
66993-894	ACITRETIN	ACITRETIN
0145-0090	SORIATANE	acitretin
0145-0091	SORIATANE	acitretin