NDC 44087-1115

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 ID: 44087-1115_2e6b585c-986b-4838-a7fa-326b34b5c146
• NDC: 44087-1115
• Product Type: Human Prescription Drug
• Proprietary Name: Gonal-f RFF Redi-ject
• Generic Name: Follitropin
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2013-10-16
• Marketing Category: NDA / NDA
• Application Number: NDA021684
• Labeler Name: EMD Serono, Inc.
• Substance Name: FOLLITROPIN
• Active Ingredient Strength: 300 [iU]/.5mL
• Pharm Classes: Gonadotropin [EPC],Gonadotropins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 44087-1115-1

1 PACKAGE in 1 CARTON (44087-1115-1) > .5 mL in 1 PACKAGE

• Marketing Start Date: 2013-10-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 44087-1115-1 [44087111501]

Gonal-f RFF Redi-ject INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021684
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-10-16

NDC 44087-1115-2 [44087111502]

Gonal-f RFF Redi-ject INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021684
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-16
• Marketing End Date: 2014-08-25

Drug Details

Active Ingredients

Ingredient	Strength
FOLLITROPIN	300 [iU]/.5mL

OpenFDA Data

• SPL SET ID: b6d11c45-b502-478e-bb28-2ff596ea259c
• Manufacturer:
  • EMD Serono, Inc.
• UNII:
  • 076WHW89TW
• 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"

NDC	Brand Name	Generic Name
44087-1115	Gonal-f RFF Redi-ject	FOLLITROPIN
44087-1116	Gonal-f RFF Redi-ject	FOLLITROPIN
44087-1117	Gonal-f RFF Redi-ject	FOLLITROPIN
44087-1118	Gonal-f RFF Redi-ject	FOLLITROPIN
0052-0313	Follistim AQ	follitropin
0052-0316	Follistim AQ	follitropin
0052-0326	Follistim AQ	follitropin