FDA.reportPublic FDA data

Follistim AQ

Product NDC
78206-131
11-digit product format
782060131
Labeler code
78206
Product ID
78206-131_1156138e-9093-46b4-aa5b-9b88e72d1790
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
follitropin
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Organon LLC
Application
BLA021211
Marketing category
BLA
Marketing start
2023-07-24
Substance
FOLLITROPIN
Active strength
900 [iU]/1.08mL
Pharmacologic classes
Gonadotropin [EPC], Gonadotropins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Follistim AQ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOLLITROPIN900 [iU]/1.08mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
076WHW89TWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854787Internal RxNorm lookup
854788Internal RxNorm lookup
854790Internal RxNorm lookup
1361563Internal RxNorm lookup
1361569Internal RxNorm lookup
1361572Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48489027-e52b-4b10-ae74-4ba03839150cAvailable on FDA.report

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-131-01Follistim AQ1 in 1 CARTONINJECTION, SOLUTION111
78206-131-01Follistim AQ1 in 1 KITINJECTION, SOLUTION111
78206-131-99Follistim AQ1.08 mL in 1 CARTRIDGEINJECTION, SOLUTION1.0811

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-131-01ML - Milliliter78206-131cb38ddd4-ad49-4ed1-abf3-cf0409c57de412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-131FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON LLC ]9Current NDC, 3 package rows20250205_48489027-e52b-4b10-ae74-4ba03839150c.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.

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
ndc (product): 78206-131

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021211Follistim AQ Cartridgefollitropin beta351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361563Follistim AQ 300 UNT in 0.36 ML CartridgePSN48489027-e52b-4b10-ae74-4ba03839150c11
1361569Follistim AQ 600 UNT in 0.72 ML CartridgePSN48489027-e52b-4b10-ae74-4ba03839150c11
1361572Follistim AQ 900 UNT in 1.08 ML CartridgePSN48489027-e52b-4b10-ae74-4ba03839150c11
854787follitropin beta 300 UNT in 0.36 ML CartridgePSN48489027-e52b-4b10-ae74-4ba03839150c11
854788follitropin beta 600 UNT in 0.72 ML CartridgePSN48489027-e52b-4b10-ae74-4ba03839150c11
854790follitropin beta 900 UNT in 1.08 ML CartridgePSN48489027-e52b-4b10-ae74-4ba03839150c11
13615630.36 ML follitropin beta 833 UNT/ML Cartridge [Follistim]SBD48489027-e52b-4b10-ae74-4ba03839150c11
13615690.72 ML follitropin beta 833 UNT/ML Cartridge [Follistim]SBD48489027-e52b-4b10-ae74-4ba03839150c11
13615721.08 ML follitropin beta 833 UNT/ML Cartridge [Follistim]SBD48489027-e52b-4b10-ae74-4ba03839150c11
8547870.36 ML follitropin beta 833 UNT/ML CartridgeSCD48489027-e52b-4b10-ae74-4ba03839150c11
8547880.72 ML follitropin beta 833 UNT/ML CartridgeSCD48489027-e52b-4b10-ae74-4ba03839150c11
8547901.08 ML follitropin beta 833 UNT/ML CartridgeSCD48489027-e52b-4b10-ae74-4ba03839150c11
13615630.36 ML Follistim 833 UNT/ML CartridgeSY48489027-e52b-4b10-ae74-4ba03839150c11
13615690.72 ML Follistim 833 UNT/ML CartridgeSY48489027-e52b-4b10-ae74-4ba03839150c11
13615721.08 ML Follistim 833 UNT/ML CartridgeSY48489027-e52b-4b10-ae74-4ba03839150c11
1361563Follistim AQ 300 IU per 0.36 ML CartridgeSY48489027-e52b-4b10-ae74-4ba03839150c11
1361569Follistim AQ 600 IU per 0.72 ML CartridgeSY48489027-e52b-4b10-ae74-4ba03839150c11
1361572Follistim AQ 900 IU per 1.08 ML CartridgeSY48489027-e52b-4b10-ae74-4ba03839150c11
854787follitropin beta 300 IU per 0.36 ML CartridgeSY48489027-e52b-4b10-ae74-4ba03839150c11
854788follitropin beta 600 IU per 0.72 ML CartridgeSY48489027-e52b-4b10-ae74-4ba03839150c11
854790follitropin beta 900 IU per 1.08 ML CartridgeSY48489027-e52b-4b10-ae74-4ba03839150c11
854790follitropin beta 900 UNT per 1.08 ML CartridgeSY48489027-e52b-4b10-ae74-4ba03839150c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78206-131-01782060131011 KIT in 1 CARTON (78206-131-01) / 1 CARTRIDGE in 1 KIT / 1.08 mL in 1 CARTRIDGE (78206-131-99) 1 kit2023-07-24NoNoCurrent
78206-131-99782060131991.08 mL in 1 CARTRIDGE1.08 mlHistorical