Home NDC 44087-1117 Gonal-f RFF Redi-ject
Product NDC 44087-1117
11-digit product format 440871117
Labeler code 44087
Product ID 44087-1117_657d712c-ea55-4e2b-9111-ed8dc792887b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FOLLITROPIN
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler EMD Serono, Inc.
Application BLA021684
Marketing category BLA
Marketing start 2013-10-16
Substance FOLLITROPIN
Active strength 900 [iU]/1.5mL
Pharmacologic classes Gonadotropin [EPC], Gonadotropins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Gonal-f RFF Redi-ject
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOLLITROPIN 900 [iU]/1.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 076WHW89TW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1594334 Internal RxNorm lookup 1594418 Internal RxNorm lookup 1594432 Internal RxNorm lookup 1654171 Internal RxNorm lookup 1654179 Internal RxNorm lookup 1654184 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44087-1117-1 Gonal-f RFF Redi-ject 1 in 1 CARTON INJECTION, SOLUTION 1 13 44087-1117-1 Gonal-f RFF Redi-ject 1.5 mL in 1 PACKAGE INJECTION, SOLUTION 1.5 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FOLLITROPIN ACTIVE INGREDIENT 076WHW89TW GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] 3 FOLLITROPIN ACTIVE MOIETY 076WHW89TW GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] 3 METACRESOL INACTIVE INGREDIENT GGO4Y809LO GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] 3 METHIONINE INACTIVE INGREDIENT AE28F7PNPL GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] 3 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] 3 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] 3 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44087-1117 GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20250406_b6d11c45-b502-478e-bb28-2ff596ea259c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021684 Gonal-f RFF RediJect follitropin alfa 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44087-1117-1 44087111701 1 PACKAGE in 1 CARTON (44087-1117-1) / 1.5 mL in 1 PACKAGE 1 package 2013-10-16 0000-00-00 No No Current