Yuviwel

Product NDC
73362-201
11-digit product format
733620201
Labeler code
73362
Product ID
73362-201_7bc0f18a-5736-4451-8790-f3780b742ab3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Navepegritide
Dosage form
KIT
Labeler
Ascendis Pharma Endocrinology, Inc.
Application
NDA219164
Marketing category
NDA
Marketing start
2026-02-27
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219164-001YUVIWELNAVEPEGRITIDE1.3MG/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-02-27
N219164-002YUVIWELNAVEPEGRITIDE2.8MG/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-02-27
N219164-003YUVIWELNAVEPEGRITIDE5.5MG/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-02-27

Orange Book patents#

Current patent rows page 1 of 1 · 36 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219164-00189068472031-04-30U-4425Drug substance, Drug product2026-03-16
N219164-001108355782037-01-05U-4425Drug substance, Drug product2026-03-16
N219164-001111545932037-01-05U-4425Drug substance, Drug product2026-03-16
N219164-001112246612037-01-05Drug substance, Drug product2026-03-16
N219164-001113116042037-01-05U-4425Drug substance, Drug product2026-03-16
N219164-001113895102037-01-05Drug substance, Drug product2026-03-16
N219164-001113895112037-01-05U-4425Drug product2026-03-16
N219164-001114133512037-01-05Drug substance, Drug product2026-03-16
N219164-001120831822037-01-05U-44252026-03-16
N219164-001121569172037-01-05U-44252026-03-16
N219164-001122396892037-01-05U-44252026-03-16
N219164-001123771332042-11-12U-4425Drug product2026-03-16
N219164-00289068472031-04-30U-4425Drug substance, Drug product2026-03-16
N219164-002108355782037-01-05U-4425Drug substance, Drug product2026-03-16
N219164-002111545932037-01-05U-4425Drug substance, Drug product2026-03-16
N219164-002112246612037-01-05Drug substance, Drug product2026-03-16
N219164-002113116042037-01-05U-4425Drug substance, Drug product2026-03-16
N219164-002113895102037-01-05Drug substance, Drug product2026-03-16
N219164-002113895112037-01-05U-4425Drug product2026-03-16
N219164-002114133512037-01-05Drug substance, Drug product2026-03-16
N219164-002120831822037-01-05U-44252026-03-16
N219164-002121569172037-01-05U-44252026-03-16
N219164-002122396892037-01-05U-44252026-03-16
N219164-002123771332042-11-12U-4425Drug product2026-03-16
N219164-00389068472031-04-30U-4425Drug substance, Drug product2026-03-16
N219164-003108355782037-01-05U-4425Drug substance, Drug product2026-03-16
N219164-003111545932037-01-05U-4425Drug substance, Drug product2026-03-16
N219164-003112246612037-01-05Drug substance, Drug product2026-03-16
N219164-003113116042037-01-05U-4425Drug substance, Drug product2026-03-16
N219164-003113895102037-01-05Drug substance, Drug product2026-03-16
N219164-003113895112037-01-05U-4425Drug product2026-03-16
N219164-003114133512037-01-05Drug substance, Drug product2026-03-16
N219164-003120831822037-01-05U-44252026-03-16
N219164-003121569172037-01-05U-44252026-03-16
N219164-003122396892037-01-05U-44252026-03-16
N219164-003123771332042-11-12U-4425Drug product2026-03-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219164-001NCE2031-02-27
N219164-001ODE-5162033-02-27
N219164-002NCE2031-02-27
N219164-002ODE-5162033-02-27
N219164-003NCE2031-02-27
N219164-003ODE-5162033-02-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N219164-001YUVIWEL1.3MG/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002YUVIWEL2.8MG/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003YUVIWEL5.5MG/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-02-27caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-001YUVIWEL1.3MG/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-002YUVIWEL2.8MG/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-003YUVIWEL5.5MG/VIALPOWDER / SUBCUTANEOUSRLD, RS2026-02-27a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N219164-00189068472031-04-30U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001108355782037-01-05U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001111545932037-01-05U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001112246612037-01-05Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001113116042037-01-05U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001113895102037-01-05Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001113895112037-01-05U-4425Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001114133512037-01-05Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001120831822037-01-05U-44252026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001121569172037-01-05U-44252026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001122396892037-01-05U-44252026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001123771332042-11-12U-4425Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-00289068472031-04-30U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002108355782037-01-05U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002111545932037-01-05U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002112246612037-01-05Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002113116042037-01-05U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002113895102037-01-05Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002113895112037-01-05U-4425Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002114133512037-01-05Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002120831822037-01-05U-44252026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002121569172037-01-05U-44252026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002122396892037-01-05U-44252026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002123771332042-11-12U-4425Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-00389068472031-04-30U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003108355782037-01-05U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003111545932037-01-05U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003112246612037-01-05Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003113116042037-01-05U-4425Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003113895102037-01-05Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003113895112037-01-05U-4425Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003114133512037-01-05Drug substance, Drug product2026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003120831822037-01-05U-44252026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003121569172037-01-05U-44252026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003122396892037-01-05U-44252026-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003123771332042-11-12U-4425Drug product2026-03-16caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-00189068472031-04-30U-4425Drug substance, Drug product2026-03-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-001108355782037-01-05U-4425Drug substance, Drug product2026-03-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-001111545932037-01-05U-4425Drug substance, Drug product2026-03-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-001112246612037-01-05Drug substance, Drug product2026-03-16a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N219164-001NCE2031-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-001ODE-5162033-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002NCE2031-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-002ODE-5162033-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003NCE2031-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07N219164-003ODE-5162033-02-27caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-001NCE2031-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-001ODE-5162033-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-002NCE2031-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-002ODE-5162033-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-003NCE2031-02-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219164-003ODE-5162033-02-27a50c72e98297…

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2739524Internal RxNorm lookup
2739529Internal RxNorm lookup
2739531Internal RxNorm lookup
2739533Internal RxNorm lookup
2739535Internal RxNorm lookup
2739537Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e01c1197-338f-414c-b804-808e129ebc8cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73362-201-01Yuviwel4 in 1 CARTONKIT44
73362-201-02Yuviwel1 in 1 BOXKIT14
73362-205-01Yuviwel1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,11.3 mg4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73362-201-01EA - Each73362-20158139d91-0c6a-4c5d-8339-ae5a1ebfaabb12026-04-20

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
YuviwelNAVEPEGRITIDEAscendis Pharma Endocrinology, Inc.e01c1197-338f-414c-b804-808e129ebc8c2026-03-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 219164
application number: NDA219164
ndc (product): 73362-201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2739524navepegritide 1.3 MG InjectionPSNe01c1197-338f-414c-b804-808e129ebc8c4
2739531navepegritide 2.8 MG InjectionPSNe01c1197-338f-414c-b804-808e129ebc8c4
2739535navepegritide 5.5 MG InjectionPSNe01c1197-338f-414c-b804-808e129ebc8c4
2739529yuviwel 1.3 MG InjectionPSNe01c1197-338f-414c-b804-808e129ebc8c4
2739533yuviwel 2.8 MG InjectionPSNe01c1197-338f-414c-b804-808e129ebc8c4
2739537yuviwel 5.5 MG InjectionPSNe01c1197-338f-414c-b804-808e129ebc8c4
2739529navepegritide 1.3 MG Injection [Yuviwel]SBDe01c1197-338f-414c-b804-808e129ebc8c4
2739533navepegritide 2.8 MG Injection [Yuviwel]SBDe01c1197-338f-414c-b804-808e129ebc8c4
2739537navepegritide 5.5 MG Injection [Yuviwel]SBDe01c1197-338f-414c-b804-808e129ebc8c4
2739524navepegritide 1.3 MG InjectionSCDe01c1197-338f-414c-b804-808e129ebc8c4
2739531navepegritide 2.8 MG InjectionSCDe01c1197-338f-414c-b804-808e129ebc8c4
2739535navepegritide 5.5 MG InjectionSCDe01c1197-338f-414c-b804-808e129ebc8c4
2739529Yuviwel 1.3 MG InjectionSYe01c1197-338f-414c-b804-808e129ebc8c4
2739533Yuviwel 2.8 MG InjectionSYe01c1197-338f-414c-b804-808e129ebc8c4
2739537Yuviwel 5.5 MG InjectionSYe01c1197-338f-414c-b804-808e129ebc8c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73362-201-01733620201014 BOX in 1 CARTON (73362-201-01) / 1 KIT in 1 BOX (73362-201-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (73362-205-01) * 1 SOLUTION in 1 SYRINGE, GLASS (73362-801-01) 4 box2026-02-27NoNoCurrent
73362-201-02733620201021 in 1 BOXHistorical
73362-205-01733620205011 in 1 VIAL, GLASSHistorical