FDA.reportPublic FDA data

Menopur

Product NDC
55566-7501
11-digit product format
555667501
Labeler code
55566
Product ID
55566-7501_86b6dd31-68e2-4309-9e5b-27ce79c8b4a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
menotropins
Dosage form
KIT
Labeler
Ferring Pharmaceuticals Inc.
Application
BLA021663
Marketing category
BLA
Marketing start
2004-10-29
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314097Internal RxNorm lookup
753990Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
22c8db95-c3db-1770-8086-31356fbabe35Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
19306eca-07d9-869e-c7a4-1581f31ccc9aProduct name220200323
568cb8c1-4b4c-2263-a98f-4f62151e332fProduct name220200323
79651c92-221b-ba7b-52e2-f902ea49889dProduct name220200323
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55566-1600-0Menopur1 in 1 VIALINJECTION59 mg47
55566-7501-1Menopur1 in 1 CARTONKIT147
55566-7501-2Menopur1 in 1 CARTONKIT147
55566-7502-0Menopur1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,575 [iU]47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55566-7501-1EA - Each55566-750154bea6da-4abf-482f-8d6c-9a097e1a2ee612012-07-24
55566-7501-2EA - Each55566-7501c9e2c6f8-ffee-4c25-955e-e19540fcadfb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FollitropinACTIVE INGREDIENT076WHW89TWMENOPUR (FOLLITROPIN AND LUTEINIZING HORMONE) KIT [FERRING PHARMACEUTICALS INC.]13
Luteinizing HormoneACTIVE INGREDIENT8XA4VN1LH4MENOPUR (FOLLITROPIN AND LUTEINIZING HORMONE) KIT [FERRING PHARMACEUTICALS INC.]13
FollitropinACTIVE MOIETY076WHW89TWMENOPUR (FOLLITROPIN AND LUTEINIZING HORMONE) KIT [FERRING PHARMACEUTICALS INC.]13
Luteinizing HormoneACTIVE MOIETY8XA4VN1LH4MENOPUR (FOLLITROPIN AND LUTEINIZING HORMONE) KIT [FERRING PHARMACEUTICALS INC.]13
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XMENOPUR (FOLLITROPIN AND LUTEINIZING HORMONE) KIT [FERRING PHARMACEUTICALS INC.]13
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHMENOPUR (FOLLITROPIN AND LUTEINIZING HORMONE) KIT [FERRING PHARMACEUTICALS INC.]13
Sodium Phosphate, Dibasic, HeptahydrateINACTIVE INGREDIENT70WT22SF4BMENOPUR (FOLLITROPIN AND LUTEINIZING HORMONE) KIT [FERRING PHARMACEUTICALS INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55566-7501MENOPUR (MENOTROPINS) KIT [FERRING PHARMACEUTICALS INC.]35Current NDC, Legacy NDC, 4 package rows20241127_22c8db95-c3db-1770-8086-31356fbabe35.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
MenopurMENOTROPINSFerring Pharmaceuticals Inc.22c8db95-c3db-1770-8086-31356fbabe352018-05-31Warnings, Adverse reactionsExact identifier
application number: BLA021663
ndc (product): 55566-7501

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021663Menopurmenotropins351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
753990Menopur 75 UNT InjectionPSN22c8db95-c3db-1770-8086-31356fbabe3547
314097menotropins 75 UNT InjectionPSN22c8db95-c3db-1770-8086-31356fbabe3547
753990follicle stimulating hormone 75 UNT / luteinizing hormone 75 UNT Injection [Menopur]SBD22c8db95-c3db-1770-8086-31356fbabe3547
314097follicle stimulating hormone 75 UNT / luteinizing hormone 75 UNT InjectionSCD22c8db95-c3db-1770-8086-31356fbabe3547
314097FSH 75 UNT / LH 75 UNT InjectionSY22c8db95-c3db-1770-8086-31356fbabe3547
753990Menopur 75 UNT InjectionSY22c8db95-c3db-1770-8086-31356fbabe3547
314097menotropins (FSH) 75 UNT / menotropins (LH) 75 UNT InjectionSY22c8db95-c3db-1770-8086-31356fbabe3547
314097menotropins 75 UNT InjectionSY22c8db95-c3db-1770-8086-31356fbabe3547

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55566-1600-0555661600001 in 1 VIALHistorical
55566-7501-1555667501011 in 1 CARTONHistorical
55566-7501-2555667501021 CARTON in 1 CARTON (55566-7501-2) / 1 KIT in 1 CARTON (55566-7501-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (55566-7502-0) * 1 INJECTION in 1 VIAL (55566-1600-0) 1 carton2004-10-290000-00-00NoNoCurrent
55566-7502-0555667502001 in 1 VIAL, SINGLE-DOSEHistorical