NDC 44087-1117

Gonal-f RFF Redi-ject

Follitropin

Gonal-f RFF Redi-ject is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Emd Serono, Inc.. The primary component is Follitropin.

Product ID44087-1117_2e6b585c-986b-4838-a7fa-326b34b5c146
NDC44087-1117
Product TypeHuman Prescription Drug
Proprietary NameGonal-f RFF Redi-ject
Generic NameFollitropin
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2013-10-16
Marketing CategoryNDA / NDA
Application NumberNDA021684
Labeler NameEMD Serono, Inc.
Substance NameFOLLITROPIN
Active Ingredient Strength900 [iU]/1.5mL
Pharm ClassesGonadotropin [EPC],Gonadotropins [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 44087-1117-1

1 PACKAGE in 1 CARTON (44087-1117-1) > 1.5 mL in 1 PACKAGE
Marketing Start Date2013-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 44087-1117-1 [44087111701]

Gonal-f RFF Redi-ject INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA021684
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-10-16

NDC 44087-1117-2 [44087111702]

Gonal-f RFF Redi-ject INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA021684
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-16
Marketing End Date2014-08-25

Drug Details

Active Ingredients

IngredientStrength
FOLLITROPIN900 [iU]/1.5mL

OpenFDA Data

SPL SET ID:b6d11c45-b502-478e-bb28-2ff596ea259c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1654179
  • 1594432
  • 1654171
  • 1594418
  • 1594334
  • 1654184
  • Pharmacological Class

    • Gonadotropin [EPC]
    • Gonadotropins [CS]

    NDC Crossover Matching brand name "Gonal-f RFF Redi-ject" or generic name "Follitropin"

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

    Trademark Results [Gonal-f RFF Redi-ject]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GONAL-F RFF REDI-JECT
    GONAL-F RFF REDI-JECT
    86110018 4689651 Live/Registered
    Merck KGaA
    2013-11-04

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