NDC 0187-5146

Retin-A MICRO

Tretinoin

Retin-A MICRO is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Tretinoin.

• Product ID: 0187-5146_6ab52736-6ad2-4cfc-92aa-3088ecee5841
• NDC: 0187-5146
• Product Type: Human Prescription Drug
• Proprietary Name: Retin-A MICRO
• Generic Name: Tretinoin
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-10-23
• Marketing Category: NDA / NDA
• Application Number: NDA020475
• Labeler Name: Bausch Health US LLC
• Substance Name: TRETINOIN
• Active Ingredient Strength: 1 mg/g
• Pharm Classes: Retinoid [EPC],Retinoids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0187-5146-02

24 TUBE in 1 TRAY (0187-5146-02) > 2 g in 1 TUBE

• Marketing Start Date: 2017-10-23
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 0187-5146-50 [00187514650]

Retin-A MICRO GEL

• Marketing Category: NDA
• Application Number: NDA020475
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2017-10-23

NDC 0187-5146-02 [00187514602]

Retin-A MICRO GEL

• Marketing Category: NDA
• Application Number: NDA020475
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-23

Drug Details

Active Ingredients

Ingredient	Strength
TRETINOIN	.6 mg/g

OpenFDA Data

• SPL SET ID: 08ab7e0c-1437-455f-815c-98904d96a289
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • 5688UTC01R
• RxNorm Concept Unique ID - RxCUI:
  • 313453
  • 805372
  • 805370
  • 1488047
  • 1488045
  • 1987646
  • 1987644
  • 359050

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]

NDC Crossover Matching brand name "Retin-A MICRO" or generic name "Tretinoin"

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