NDC 10631-116

Absorica

Isotretinoin

Absorica is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Isotretinoin.

Product ID10631-116_226dda6c-17ec-4e33-858a-86c0654d9946
NDC10631-116
Product TypeHuman Prescription Drug
Proprietary NameAbsorica
Generic NameIsotretinoin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2012-06-08
Marketing CategoryNDA / NDA
Application NumberNDA021951
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameISOTRETINOIN
Active Ingredient Strength20 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10631-116-31

3 BLISTER PACK in 1 BOX (10631-116-31) > 10 CAPSULE in 1 BLISTER PACK (10631-116-69)
Marketing Start Date2012-06-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10631-116-31 [10631011631]

Absorica CAPSULE
Marketing CategoryNDA
Application NumberNDA021951
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-06-08

NDC 10631-116-69 [10631011669]

Absorica CAPSULE
Marketing CategoryNDA
Application NumberNDA021951
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-06-08

Drug Details

Active Ingredients

IngredientStrength
ISOTRETINOIN20 mg/1

OpenFDA Data

SPL SET ID:3ef0cff8-19c1-4441-b780-fca6c7ee1615
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197843
  • 403930
  • 197845
  • 197844
  • 1299203
  • 1300014
  • 1300006
  • 1300016
  • 1547567
  • 1547565
  • 1547563
  • 1547561
  • Pharmacological Class

    • Retinoid [EPC]
    • Retinoids [CS]

    Medicade Reported Pricing

    10631011631 ABSORICA 20 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Absorica" or generic name "Isotretinoin"

    NDCBrand NameGeneric Name
    10631-134AbsoricaAbsorica
    10631-116AbsoricaAbsorica
    10631-115AbsoricaAbsorica
    10631-118AbsoricaAbsorica
    10631-133AbsoricaAbsorica
    10631-117AbsoricaAbsorica
    0378-6611Amnesteemisotretinoin
    0378-6612Amnesteemisotretinoin
    0378-6614Amnesteemisotretinoin
    0555-1054ClaravisIsotretinoin
    0555-1055ClaravisIsotretinoin
    0555-1056ClaravisIsotretinoin
    0555-1057ClaravisIsotretinoin
    0245-0570IsotretinoinIsotretinoin
    0245-0571IsotretinoinIsotretinoin
    0245-0573IsotretinoinIsotretinoin
    0245-0575IsotretinoinIsotretinoin

    Trademark Results [Absorica]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ABSORICA
    ABSORICA
    85245137 4286530 Live/Registered
    SUN PHARMACEUTICAL INDUSTRIES, INC.
    2011-02-17

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