Home NDC 0052-0316-01 Follistim AQ
Product NDC 0052-0316
Requested package NDC 0052-0316-01
11-digit product format 000520316
Labeler code 0052
Product ID 0052-0316_19e6b8fb-87e6-4dca-96c4-3cf8385533c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name follitropin
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Merck Sharp & Dohme LLC
Application BLA021211
Marketing category BLA
Marketing start 2004-03-24
Marketing end 0000-00-00
Substance FOLLITROPIN
Active strength 650 [iU]/.78mL
Pharmacologic classes Gonadotropin [EPC], Gonadotropins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0052-0316-01 2021-09-17 These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 0052-0316-01 2021-09-17 These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 0052-0316-81 2021-09-17 These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 0052-0316-81 2021-09-17 These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 0052-0316-01 2021-07-23 These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 0052-0316-01 2021-07-23 These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 0052-0316-81 2021-07-23 These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997 0052-0316-81 2021-07-23 These highlights do not include all the information needed to use FOLLISTIM AQ Cartridge safely and effectively. See full prescribing information for FOLLISTIM AQ Cartridge. FOLLISTIM ® AQ Cartridge (follitropin beta) injection, for subcutaneous use Initial U.S. Approval: 1997
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded follitropin ACTIVE INGREDIENT 076WHW89TW FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] 13 follitropin ACTIVE MOIETY 076WHW89TW FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] 13 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] 13 hydrochloric acid INACTIVE INGREDIENT QTT17582CB FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] 13 methionine INACTIVE INGREDIENT AE28F7PNPL FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] 13 polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] 13 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] 13 sucrose INACTIVE INGREDIENT C151H8M554 FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] 13 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] 13 water INACTIVE INGREDIENT 059QF0KO0R FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.] 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0052-0316 FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC] 25 Legacy NDC 20241129_96f11b5d-cc7b-48aa-830a-a28e1962d871.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 021211 Follistim AQ Cartridge follitropin beta 351(a) Rx 2026-07-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0052-0316-01 00052031601 1 KIT in 1 CARTON (0052-0316-01) > 1 CARTRIDGE in 1 KIT > .78 mL in 1 CARTRIDGE 1 kit 2004-03-24 0000-00-00 No No Current