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 Identifiers#

Field, Values table
FieldValues
Rxcui314097, 753990

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

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