NDC 44087-1118

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: 44087-1118_d39eb481-5425-43b2-8b7a-4aa5b570e756
• NDC: 44087-1118
• 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: 2019-11-25
• Marketing Category: NDA / NDA
• Application Number: NDA021684
• Labeler Name: EMD Serono, Inc.
• Substance Name: FOLLITROPIN
• Active Ingredient Strength: 150 [iU]/.25mL
• Pharm Classes: Gonadotropin [EPC],Gonadotropins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 44087-1118-1

1 PACKAGE in 1 CARTON (44087-1118-1) > .25 mL in 1 PACKAGE

• Marketing Start Date: 2019-11-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 44087-1118-1 [44087111801]

Gonal-f RFF Redi-ject INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA021684
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-11-25
• Marketing End Date: 2019-11-25

Drug Details

Active Ingredients

Ingredient	Strength
FOLLITROPIN	150 [iU]/.25mL

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