FDA.reportPublic FDA data

Skytrofa

Product NDC
73362-004
11-digit product format
733620004
Labeler code
73362
Product ID
73362-004_f0f1bf14-7ce1-4d9c-9b80-4da87d1496de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lonapegsomatropin-tcgd
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
Ascendis Pharma Endocrinology, Inc.
Application
BLA761177
Marketing category
BLA
Marketing start
2021-08-25
Substance
LONAPEGSOMATROPIN
Active strength
3.6 mg/1
Pharmacologic classes
Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Skytrofa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LONAPEGSOMATROPIN3.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOP35X9610Y
Rxcui2569603, 2569605, 2569607, 2569609, 2569611, 2569613, 2569615, 2569617, 2569619, 2569621, 2569623, 2569625, 2569627, 2569629, 2569631, 2569633, 2569635, 2569637, 2721785, 2721787

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
608ae03f-9d34-4c2b-aaf8-bc49108e3854Product name120220309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73362-004-01Skytrofa4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,411
73362-004-02Skytrofa1 in 1 CARTRIDGEINJECTION, POWDER, LYOPHILIZED,111
73362-004-02Skytrofa1 in 1 BLISTER PACKINJECTION, POWDER, LYOPHILIZED,111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73362-004-01EA - Each73362-0040c8d9998-2c08-42f1-8b06-7c73b15a3c6b12021-11-09
73362-004-02EA - Each73362-004c17dd81e-4912-45a8-815a-5313ece6699212021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73362-004SKYTROFA (LONAPEGSOMATROPIN-TCGD) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASCENDIS PHARMA ENDOCRINOLOGY, INC.]8Current NDC, Legacy NDC, 3 package rows20250508_9229f871-bc61-4ddc-8122-d126d40e36ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2721801lonapegsomatropin-tcgd 0.7 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2721797lonapegsomatropin-tcgd 1.4 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2721793lonapegsomatropin-tcgd 1.8 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569603lonapegsomatropin-tcgd 11 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569607lonapegsomatropin-tcgd 13.3 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2721789lonapegsomatropin-tcgd 2.1 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2721785lonapegsomatropin-tcgd 2.5 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569611lonapegsomatropin-tcgd 3 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569615lonapegsomatropin-tcgd 3.6 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569619lonapegsomatropin-tcgd 4.3 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569623lonapegsomatropin-tcgd 5.2 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569627lonapegsomatropin-tcgd 6.3 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569631lonapegsomatropin-tcgd 7.6 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569635lonapegsomatropin-tcgd 9.1 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2721803Skytrofa 0.7 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2721799Skytrofa 1.4 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2721795Skytrofa 1.8 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569605Skytrofa 11 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569609Skytrofa 13.3 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2721791Skytrofa 2.1 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2721787Skytrofa 2.5 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569613Skytrofa 3 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569617Skytrofa 3.6 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569621Skytrofa 4.3 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569625Skytrofa 5.2 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569629Skytrofa 6.3 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569633Skytrofa 7.6 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2569637Skytrofa 9.1 MG CartridgePSN9229f871-bc61-4ddc-8122-d126d40e36ac11
2721803lonapegsomatropin-tcgd 0.7 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2721799lonapegsomatropin-tcgd 1.4 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2721795lonapegsomatropin-tcgd 1.8 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569605lonapegsomatropin-tcgd 11 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569609lonapegsomatropin-tcgd 13.3 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2721791lonapegsomatropin-tcgd 2.1 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2721787lonapegsomatropin-tcgd 2.5 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569613lonapegsomatropin-tcgd 3 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569617lonapegsomatropin-tcgd 3.6 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569621lonapegsomatropin-tcgd 4.3 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569625lonapegsomatropin-tcgd 5.2 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569629lonapegsomatropin-tcgd 6.3 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569633lonapegsomatropin-tcgd 7.6 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569637lonapegsomatropin-tcgd 9.1 MG Cartridge [Skytrofa]SBD9229f871-bc61-4ddc-8122-d126d40e36ac11
2721801lonapegsomatropin-tcgd 0.7 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2721797lonapegsomatropin-tcgd 1.4 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2721793lonapegsomatropin-tcgd 1.8 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569603lonapegsomatropin-tcgd 11 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569607lonapegsomatropin-tcgd 13.3 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2721789lonapegsomatropin-tcgd 2.1 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2721785lonapegsomatropin-tcgd 2.5 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569611lonapegsomatropin-tcgd 3 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569615lonapegsomatropin-tcgd 3.6 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569619lonapegsomatropin-tcgd 4.3 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569623lonapegsomatropin-tcgd 5.2 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569627lonapegsomatropin-tcgd 6.3 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569631lonapegsomatropin-tcgd 7.6 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2569635lonapegsomatropin-tcgd 9.1 MG CartridgeSCD9229f871-bc61-4ddc-8122-d126d40e36ac11
2721803Skytrofa 0.7 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2721799Skytrofa 1.4 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2721795Skytrofa 1.8 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2569605Skytrofa 11 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2569609Skytrofa 13.3 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2721791Skytrofa 2.1 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2721787Skytrofa 2.5 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2569613Skytrofa 3 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2569617Skytrofa 3.6 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2569621Skytrofa 4.3 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2569625Skytrofa 5.2 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2569629Skytrofa 6.3 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2569633Skytrofa 7.6 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11
2569637Skytrofa 9.1 MG CartridgeSY9229f871-bc61-4ddc-8122-d126d40e36ac11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73362-004-01733620004014 BLISTER PACK in 1 CARTON (73362-004-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-004-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE4 blister pack2021-08-250000-00-00NoNoCurrent
73362-004-02733620004021 in 1 CARTRIDGEHistorical