NDC 0052-0313

Follistim AQ

Follitropin

Follistim AQ is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Llc. The primary component is Follitropin.

Product ID0052-0313_19e6b8fb-87e6-4dca-96c4-3cf8385533c1
NDC0052-0313
Product TypeHuman Prescription Drug
Proprietary NameFollistim AQ
Generic NameFollitropin
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2004-03-24
Marketing CategoryBLA / NDA
Application NumberBLA021211
Labeler NameMerck Sharp & Dohme LLC
Substance NameFOLLITROPIN
Active Ingredient Strength350 [iU]/.42mL
Pharm ClassesGonadotropin [EPC], Gonadotropins [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0052-0313-01

1 KIT in 1 CARTON (0052-0313-01) > 1 CARTRIDGE in 1 KIT > .42 mL in 1 CARTRIDGE
Marketing Start Date2004-03-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0052-0313-01 [00052031301]

Follistim AQ INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021211
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-03-24

NDC 0052-0313-81 [00052031381]

Follistim AQ INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021211
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-03-24

Drug Details

Active Ingredients

IngredientStrength
FOLLITROPIN350 [iU]/.42mL

OpenFDA Data

SPL SET ID:96f11b5d-cc7b-48aa-830a-a28e1962d871
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1361563
  • 1361569
  • 1361572
  • 854787
  • 854788
  • 854790
  • Pharmacological Class

    • Gonadotropin [EPC]
    • Gonadotropins [CS]

    NDC Crossover Matching brand name "Follistim AQ" or generic name "Follitropin"

    NDCBrand NameGeneric Name
    0052-0313Follistim AQfollitropin
    0052-0316Follistim AQfollitropin
    0052-0326Follistim AQfollitropin
    44087-1115Gonal-f RFF Redi-jectFOLLITROPIN
    44087-1116Gonal-f RFF Redi-jectFOLLITROPIN
    44087-1117Gonal-f RFF Redi-jectFOLLITROPIN
    44087-1118Gonal-f RFF Redi-jectFOLLITROPIN

    Trademark Results [Follistim AQ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FOLLISTIM AQ
    FOLLISTIM AQ
    78584155 3166497 Live/Registered
    MERCK SHARP & DOHME B.V.
    2005-03-10
    FOLLISTIM AQ
    FOLLISTIM AQ
    76170241 not registered Dead/Abandoned
    N.V. Organon
    2000-11-22

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