FDA.reportPublic FDA data

Skytrofa

Product NDC
73362-008
11-digit product format
733620008
Labeler code
73362
Product ID
73362-008_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
7.6 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LONAPEGSOMATROPIN7.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OP35X9610YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 28 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2569603Internal RxNorm lookup
2569605Internal RxNorm lookup
2569607Internal RxNorm lookup
2569609Internal RxNorm lookup
2569611Internal RxNorm lookup
2569613Internal RxNorm lookup
2569615Internal RxNorm lookup
2569617Internal RxNorm lookup
2569619Internal RxNorm lookup
2569621Internal RxNorm lookup
2569623Internal RxNorm lookup
2569625Internal RxNorm lookup
2569627Internal RxNorm lookup
2569629Internal RxNorm lookup
2569631Internal RxNorm lookup
2569633Internal RxNorm lookup
2569635Internal RxNorm lookup
2569637Internal RxNorm lookup
2721785Internal RxNorm lookup
2721787Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9229f871-bc61-4ddc-8122-d126d40e36acAvailable on FDA.report

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
73362-008-01Skytrofa4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,411
73362-008-02Skytrofa1 in 1 CARTRIDGEINJECTION, POWDER, LYOPHILIZED,111
73362-008-02Skytrofa1 in 1 BLISTER PACKINJECTION, POWDER, LYOPHILIZED,111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73362-008-01EA - Each73362-008204da8c3-a125-43bb-9a95-cca05e89b1d712021-11-09
73362-008-02EA - Each73362-008813de8ee-002e-4335-9790-59e16f8f342112021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73362-008SKYTROFA (LONAPEGSOMATROPIN-TCGD) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASCENDIS PHARMA ENDOCRINOLOGY, INC.]8Current NDC, Legacy NDC, 3 package rows20250508_9229f871-bc61-4ddc-8122-d126d40e36ac.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
SkytrofaLONAPEGSOMATROPIN-TCGDAscendis Pharma Endocrinology, Inc.9229f871-bc61-4ddc-8122-d126d40e36ac2026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA761177
ndc (product): 73362-008

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761177Skytrofalonapegsomatropin-tcgd351(a)Rx2026-07-01

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
73362-008-01733620008014 BLISTER PACK in 1 CARTON (73362-008-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-008-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE4 blister pack2021-08-250000-00-00NoNoCurrent
73362-008-02733620008021 in 1 CARTRIDGEHistorical