Home NDC 0052-0313 Follistim AQ
Product NDC 0052-0313
11-digit product format 000520313
Labeler code 0052
Product ID 0052-0313_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 350 [iU]/.42mL
Pharmacologic classes Gonadotropin [EPC], Gonadotropins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
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DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 0052-0313-01 2021-09-17 C162847 48780-1 c7ccaba7-10f5-fd44-e053-dadaa90aa01b 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 0052-0313-01 2021-09-17 C162847 48780-1 c7ccaba7-10f5-fd44-e053-dadaa90aa01b 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 0052-0313-81 2021-09-17 C162847 48780-1 c7ccaba7-10f5-fd44-e053-dadaa90aa01b 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 0052-0313-81 2021-09-17 C162847 48780-1 c7ccaba7-10f5-fd44-e053-dadaa90aa01b 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 0052-0313-01 2021-07-23 C162847 48780-1 c7ccaba7-10f5-fd44-e053-dadaa90aa01b 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 0052-0313-01 2021-07-23 C162847 48780-1 c7ccaba7-10f5-fd44-e053-dadaa90aa01b 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 0052-0313-81 2021-07-23 C162847 48780-1 c7ccaba7-10f5-fd44-e053-dadaa90aa01b 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 0052-0313-81 2021-07-23 C162847 48780-1 c7ccaba7-10f5-fd44-e053-dadaa90aa01b 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 0052-0313 FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC] 25 Legacy NDC 20241129_96f11b5d-cc7b-48aa-830a-a28e1962d871.zip
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 2026-06-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0052-0313-01 00052031301 1 KIT in 1 CARTON (0052-0313-01) > 1 CARTRIDGE in 1 KIT > .42 mL in 1 CARTRIDGE 1 kit 2004-03-24 0000-00-00 No No Current 0052-0313-81 00052031381 1 KIT in 1 CARTON (0052-0313-81) > 1 CARTRIDGE in 1 KIT > .42 mL in 1 CARTRIDGE 1 kit 2004-03-24 0000-00-00 No No Current