NDC 0378-8093

Tretinoin

Tretinoin

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.

Product ID0378-8093_04936b5b-bcbd-4e68-826e-67a5ef000fe5
NDC0378-8093
Product TypeHuman Prescription Drug
Proprietary NameTretinoin
Generic NameTretinoin
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2018-11-05
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020475
Labeler NameMylan Pharmaceuticals Inc.
Substance NameTRETINOIN
Active Ingredient Strength1 mg/g
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-8093-20

1 TUBE in 1 CARTON (0378-8093-20) > 20 g in 1 TUBE
Marketing Start Date2018-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8093-45 [00378809345]

Tretinoin GEL
Marketing CategoryNDA authorized generic
Application NumberNDA020475
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-12-17

NDC 0378-8093-20 [00378809320]

Tretinoin GEL
Marketing CategoryNDA authorized generic
Application NumberNDA020475
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2018-12-17

NDC 0378-8093-50 [00378809350]

Tretinoin GEL
Marketing CategoryNDA authorized generic
Application NumberNDA020475
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-10-16

Drug Details

Active Ingredients

IngredientStrength
TRETINOIN1 mg/g

OpenFDA Data

SPL SET ID:ff10a007-5814-4794-8ce3-da5cc85fca85
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313453
  • 359050
  • Pharmacological Class

    • Retinoid [EPC]
    • Retinoids [CS]

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

    NDCBrand NameGeneric Name
    68084-075TretinoinTretinoin
    0472-0117TretinoinTretinoin
    68462-792TretinoinTretinoin
    68682-514TretinoinTretinoin
    68682-800TretinoinTretinoin
    68682-513TretinoinTretinoin
    68788-7039TRETINOINTRETINOIN
    68682-515TretinoinTretinoin
    0555-0808TretinoinTretinoin
    0574-2205TRETINOINTRETINOIN
    0574-2225TRETINOINTRETINOIN
    0574-2325TRETINOINTRETINOIN
    0574-2201TRETINOINTRETINOIN
    0574-2301TRETINOINTRETINOIN
    10370-268TretinoinTretinoin
    21695-805TretinoinTretinoin
    21695-655TretinoinTretinoin
    21695-804TretinoinTretinoin
    21695-763TretinoinTretinoin
    42254-151TretinoinTretinoin
    42291-843TretinoinTretinoin
    43478-241TretinoinTretinoin
    43478-242TretinoinTretinoin
    43478-245TretinoinTretinoin
    50090-0651TretinoinTretinoin
    50090-2232TretinoinTretinoin
    50090-2065TretinoinTretinoin
    50090-3090TRETINOINTRETINOIN
    50090-3128TRETINOINTRETINOIN
    50090-3058TRETINOINTRETINOIN
    51672-1394TretinoinTretinoin
    51672-1395TretinoinTretinoin
    55045-3691TretinoinTretinoin
    62032-413TretinoinTretinoin
    0378-8092TretinoinTretinoin
    0378-8093TretinoinTretinoin
    0378-8090TretinoinTretinoin
    66530-257TretinoinTretinoin
    66530-256TretinoinTretinoin
    66530-253TretinoinTretinoin
    66530-255TretinoinTretinoin
    66530-254TretinoinTretinoin
    0904-6867TretinoinTretinoin
    50090-4347TretinoinTretinoin
    50090-4486TretinoinTretinoin
    0187-0005Altrenotretinoin
    0187-5150RenovaTretinoin
    0187-5160Retin-ATretinoin
    0187-5162Retin-ATretinoin
    0187-5164Retin-ATretinoin

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