FDA.reportPublic FDA data

Follistim AQ

Product NDC
78206-129
11-digit product format
782060129
Labeler code
78206
Product ID
78206-129_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
300 [iU]/.36mL
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
FOLLITROPIN300 [iU]/.36mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii076WHW89TW
Rxcui854787, 854788, 854790, 1361563, 1361569, 1361572

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
78206-129-01Follistim AQ1 in 1 CARTONINJECTION, SOLUTION111
78206-129-01Follistim AQ1 in 1 KITINJECTION, SOLUTION111
78206-129-58Follistim AQ0.36 mL in 1 CARTRIDGEINJECTION, SOLUTION0.3611
78206-129-59Follistim AQ1 in 1 CARTONINJECTION, SOLUTION111
78206-129-59Follistim AQ1 in 1 KITINJECTION, SOLUTION111
78206-129-99Follistim AQ0.36 mL in 1 CARTRIDGEINJECTION, SOLUTION0.3611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-129-01ML - Milliliter78206-129595a43b9-030c-420b-92b6-6381fee2d05c12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-129FOLLISTIM AQ (FOLLITROPIN) INJECTION, SOLUTION [ORGANON LLC ]9Current NDC, 6 package rows20250205_48489027-e52b-4b10-ae74-4ba03839150c.zip

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
78206-129-01782060129011 KIT in 1 CARTON (78206-129-01) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-99) 1 kit2023-07-24NoNoHistorical
78206-129-58782060129580.36 mL in 1 CARTRIDGE0.36 mlHistorical
78206-129-59782060129591 KIT in 1 CARTON (78206-129-59) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-58) 1 kit2023-07-24YesNoHistorical
78206-129-99782060129990.36 mL in 1 CARTRIDGE0.36 mlHistorical