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NDC 00378-8092-45 Tretinoin 0.4 mg/g Details

Tretinoin 0.4 mg/g

Tretinoin is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is TRETINOIN.

MedlinePlus Drug Summary

Tretinoin (Altreno, Atralin, Avita, Retin-A) is used to treat acne. Tretinoin is also used to reduce fine wrinkles (Refissa and Renova) and to improve spotty discoloration (Renova) and rough feeling skin (Renova) when used along with other skin care and sunlight avoidance programs. Tretinoin is in a class of medications called retinoids. It works by promoting peeling of affected skin areas and unclogging pores.

Related Packages: 00378-8092-45
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tretinoin Topical

Product Information

NDC	00378-8092
Product ID	0378-8092_0eee5219-ac85-4f0b-a185-668e9eb2b739
Associated GPIs	90050030204015
GCN Sequence Number	050417
GCN Sequence Number Description	tretinoin microspheres GEL (GRAM) 0.04 % TOPICAL
HIC3	L9B
HIC3 Description	VITAMIN A DERIVATIVES
GCN	17443
HICL Sequence Number	032888
HICL Sequence Number Description	TRETINOIN MICROSPHERES
Brand/Generic	Generic
Proprietary Name	Tretinoin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Tretinoin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.4
Active Ingredient Units	mg/g
Substance Name	TRETINOIN
Labeler Name	Mylan Pharmaceuticals Inc.
Pharmaceutical Class	Retinoid [EPC], Retinoids [CS]
DEA Schedule	n/a
Marketing Category	NDA AUTHORIZED GENERIC
Application Number	NDA020475
Listing Certified Through	2024-12-31

Package

NDC 00378-8092-45 (00378809245)

Pricing Information	N/A
NDC Package Code	0378-8092-45
Billing NDC	00378809245
Package	1 TUBE in 1 CARTON (0378-8092-45) / 45 g in 1 TUBE
Marketing Start Date	2019-08-26
NDC Exclude Flag	N