Home NDC 44087-9005 GONAL-F RFF
Product NDC 44087-9005
11-digit product format 440879005
Labeler code 44087
Product ID 44087-9005_74b90b4d-0b84-4185-aff6-4b5d58ad8555
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name follitropin alfa
Dosage form KIT
Route SUBCUTANEOUS
Labeler EMD Serono, Inc.
Application BLA021765
Marketing category BLA
Marketing start 2004-03-25
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 44087-9005 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 44087-9005 44087-9005-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 44087-9005 44087-9005-6 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FOLLITROPIN ACTIVE INGREDIENT 076WHW89TW GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] 7 FOLLITROPIN ACTIVE MOIETY 076WHW89TW GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] 7 METHIONINE INACTIVE INGREDIENT AE28F7PNPL GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] 7 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] 7 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] 7 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] 7 SUCROSE INACTIVE INGREDIENT C151H8M554 GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44087-9005 GONAL-F RFF (FOLLITROPIN ALFA) KIT [EMD SERONO, INC.] 15 Legacy NDC 20231124_aa759a1b-2c1d-438b-bd7e-019a2067699d.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021765 Gonal-f RFF follitropin alfa 351(a) Disc 2026-06-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44087-9005-1 44087900501 1 BLISTER PACK in 1 CARTON (44087-9005-1) > 1 KIT in 1 BLISTER PACK * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS (44087-9998-1) 1 blister pack 2004-03-25 0000-00-00 No No Current 44087-9005-6 44087900506 10 BLISTER PACK in 1 CARTON (44087-9005-6) > 1 KIT in 1 BLISTER PACK * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS (44087-9998-1) 10 blister pack 2004-03-25 0000-00-00 No No Current