FDA.reportPublic FDA data

Follistim AQ

Product NDC
0052-0326
11-digit product format
000520326
Labeler code
0052
Product ID
0052-0326_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
975 [iU]/1.17mL
Pharmacologic classes
Gonadotropin [EPC], Gonadotropins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0052-0326DDiscontinued by firm2026-07-31
excluded packagepackage0052-03260052-0326-01DDiscontinued by firm2026-07-31

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Follistim AQFOLLITROPINOrganon LLC48489027-e52b-4b10-ae74-4ba03839150c2026-05-26Warnings, Adverse reactionsExact identifier
application number: BLA021211

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
19306eca-07d9-869e-c7a4-1581f31ccc9aProduct name220200323
568cb8c1-4b4c-2263-a98f-4f62151e332fProduct name220200323
79651c92-221b-ba7b-52e2-f902ea49889dProduct name220200323
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0052-0326-012021-09-17C16284748780-1c7ccaba7-10f5-fd44-e053-dadaa90aa01bThese 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
0052-0326-012021-09-17C16284748780-1c7ccaba7-10f5-fd44-e053-dadaa90aa01bThese 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
0052-0326-012021-07-23C16284748780-1c7ccaba7-10f5-fd44-e053-dadaa90aa01bThese 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
0052-0326-012021-07-23C16284748780-1c7ccaba7-10f5-fd44-e053-dadaa90aa01bThese 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0052-0326-01ML - Milliliter0052-03266ceea1c1-31bd-4987-90b3-56dbc988d10412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
follitropinACTIVE INGREDIENT076WHW89TWFOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.]13
follitropinACTIVE MOIETY076WHW89TWFOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.]13
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHFOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.]13
hydrochloric acidINACTIVE INGREDIENTQTT17582CBFOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.]13
methionineINACTIVE INGREDIENTAE28F7PNPLFOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.]13
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHFOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.]13
sodium hydroxideINACTIVE INGREDIENT55X04QC32IFOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.]13
sucroseINACTIVE INGREDIENTC151H8M554FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.]13
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KFOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.]13
waterINACTIVE INGREDIENT059QF0KO0RFOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON USA INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0052-0326FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC]25Legacy NDC20241129_96f11b5d-cc7b-48aa-830a-a28e1962d871.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021211Follistim AQ Cartridgefollitropin beta351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0052-0326-01000520326011 KIT in 1 CARTON (0052-0326-01) > 1 CARTRIDGE in 1 KIT > 1.17 mL in 1 CARTRIDGE1 kit2004-03-240000-00-00NoNoCurrent