NDC 0378-6140

Avita

Tretinoin

Avita is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Tretinoin.

• Product ID: 0378-6140_792f1984-39a0-4e6a-8dcf-07c28e3bae59
• NDC: 0378-6140
• Product Type: Human Prescription Drug
• Proprietary Name: Avita
• Generic Name: Tretinoin
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 1998-03-18
• Marketing Category: NDA / NDA
• Application Number: NDA020400
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: TRETINOIN
• Active Ingredient Strength: 0 mg/g
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0378-6140-44

20 g in 1 TUBE (0378-6140-44)

• Marketing Start Date: 1998-03-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-6140-44 [00378614044]

Avita GEL

• Marketing Category: NDA
• Application Number: NDA020400
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 1998-03-18

NDC 0378-6140-45 [00378614045]

Avita GEL

• Marketing Category: NDA
• Application Number: NDA020400
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 1998-03-18

Drug Details

Active Ingredients

Ingredient	Strength
TRETINOIN	.25 mg/g

OpenFDA Data

• SPL SET ID: 6bb07b84-68bd-4513-b0cf-e2e949eaa964
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 5688UTC01R
• RxNorm Concept Unique ID - RxCUI:
  • 208332
  • 313451

Pharmacological Class

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

NDC Crossover Matching brand name "Avita" or generic name "Tretinoin"

NDC	Brand Name	Generic Name
0378-6140	Avita	Avita
0378-6141	Avita	Avita
0187-0005	Altreno	tretinoin
0187-5150	Renova	Tretinoin
0187-5160	Retin-A	Tretinoin
0187-5162	Retin-A	Tretinoin
0187-5164	Retin-A	Tretinoin
0187-5140	Retin-A MICRO	Tretinoin
0187-5144	Retin-A MICRO	Tretinoin
0187-5146	Retin-A MICRO	Tretinoin
0187-5148	Retin-A MICRO	Tretinoin