NDC 42851-012

Refissa Tretinoin (Emollient)

Tretinoin

Refissa Tretinoin (Emollient) is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Zo Skin Health, Inc.. The primary component is Tretinoin.

Product ID42851-012_a3c1c3b4-13ef-a625-e053-2995a90af78f
NDC42851-012
Product TypeHuman Prescription Drug
Proprietary NameRefissa Tretinoin (Emollient)
Generic NameTretinoin
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2017-04-03
Marketing CategoryANDA / ANDA
Application NumberANDA076498
Labeler NameZO Skin Health, Inc.
Substance NameTRETINOIN
Active Ingredient Strength1 mg/g
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42851-012-20

1 TUBE in 1 CARTON (42851-012-20) > 20 g in 1 TUBE
Marketing Start Date2017-04-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42851-012-40 [42851001240]

Refissa Tretinoin (Emollient) CREAM
Marketing CategoryANDA
Application NumberANDA076498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-04-03

NDC 42851-012-20 [42851001220]

Refissa Tretinoin (Emollient) CREAM
Marketing CategoryANDA
Application NumberANDA076498
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-04-03

Drug Details

Active Ingredients

IngredientStrength
TRETINOIN.5 mg/g

OpenFDA Data

SPL SET ID:ff700fb5-d9fd-4060-b7ef-8fc7ff5a85fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855687
  • 2117659
  • Pharmacological Class

    • Retinoid [EPC]
    • Retinoids [CS]

    NDC Crossover Matching brand name "Refissa Tretinoin (Emollient)" or generic name "Tretinoin"

    NDCBrand NameGeneric Name
    42851-012Refissa Tretinoin (Emollient)Refissa Tretinoin (Emollient)
    0187-0005Altrenotretinoin
    0187-5150RenovaTretinoin
    0187-5160Retin-ATretinoin
    0187-5162Retin-ATretinoin
    0187-5164Retin-ATretinoin
    0187-5140Retin-A MICROTretinoin
    0187-5144Retin-A MICROTretinoin
    0187-5146Retin-A MICROTretinoin
    0187-5148Retin-A MICROTretinoin

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