Home NDC 73362-203 Yuviwel
Product NDC 73362-203
11-digit product format 733620203
Labeler code 73362
Product ID 73362-203_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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219164-001 YUVIWEL NAVEPEGRITIDE 1.3MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-02-27 N219164-002 YUVIWEL NAVEPEGRITIDE 2.8MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-02-27 N219164-003 YUVIWEL NAVEPEGRITIDE 5.5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-02-27
Orange Book patents# Current patent rows page 1 of 1 · 36 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219164-001 8906847 2031-04-30 U-4425 Drug substance, Drug product 2026-03-16 N219164-001 10835578 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 N219164-001 11154593 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 N219164-001 11224661 2037-01-05 Drug substance, Drug product 2026-03-16 N219164-001 11311604 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 N219164-001 11389510 2037-01-05 Drug substance, Drug product 2026-03-16 N219164-001 11389511 2037-01-05 U-4425 Drug product 2026-03-16 N219164-001 11413351 2037-01-05 Drug substance, Drug product 2026-03-16 N219164-001 12083182 2037-01-05 U-4425 2026-03-16 N219164-001 12156917 2037-01-05 U-4425 2026-03-16 N219164-001 12239689 2037-01-05 U-4425 2026-03-16 N219164-001 12377133 2042-11-12 U-4425 Drug product 2026-03-16 N219164-002 8906847 2031-04-30 U-4425 Drug substance, Drug product 2026-03-16 N219164-002 10835578 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 N219164-002 11154593 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 N219164-002 11224661 2037-01-05 Drug substance, Drug product 2026-03-16 N219164-002 11311604 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 N219164-002 11389510 2037-01-05 Drug substance, Drug product 2026-03-16 N219164-002 11389511 2037-01-05 U-4425 Drug product 2026-03-16 N219164-002 11413351 2037-01-05 Drug substance, Drug product 2026-03-16 N219164-002 12083182 2037-01-05 U-4425 2026-03-16 N219164-002 12156917 2037-01-05 U-4425 2026-03-16 N219164-002 12239689 2037-01-05 U-4425 2026-03-16 N219164-002 12377133 2042-11-12 U-4425 Drug product 2026-03-16 N219164-003 8906847 2031-04-30 U-4425 Drug substance, Drug product 2026-03-16 N219164-003 10835578 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 N219164-003 11154593 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 N219164-003 11224661 2037-01-05 Drug substance, Drug product 2026-03-16 N219164-003 11311604 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 N219164-003 11389510 2037-01-05 Drug substance, Drug product 2026-03-16 N219164-003 11389511 2037-01-05 U-4425 Drug product 2026-03-16 N219164-003 11413351 2037-01-05 Drug substance, Drug product 2026-03-16 N219164-003 12083182 2037-01-05 U-4425 2026-03-16 N219164-003 12156917 2037-01-05 U-4425 2026-03-16 N219164-003 12239689 2037-01-05 U-4425 2026-03-16 N219164-003 12377133 2042-11-12 U-4425 Drug product 2026-03-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N219164-001 YUVIWEL 1.3MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 YUVIWEL 2.8MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 YUVIWEL 5.5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-02-27 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219164-001 YUVIWEL 1.3MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-02-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219164-002 YUVIWEL 2.8MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-02-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219164-003 YUVIWEL 5.5MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2026-02-27 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N219164-001 8906847 2031-04-30 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-001 10835578 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-001 11154593 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-001 11224661 2037-01-05 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-001 11311604 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-001 11389510 2037-01-05 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-001 11389511 2037-01-05 U-4425 Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-001 11413351 2037-01-05 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-001 12083182 2037-01-05 U-4425 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-001 12156917 2037-01-05 U-4425 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-001 12239689 2037-01-05 U-4425 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-001 12377133 2042-11-12 U-4425 Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 8906847 2031-04-30 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 10835578 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 11154593 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 11224661 2037-01-05 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 11311604 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 11389510 2037-01-05 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 11389511 2037-01-05 U-4425 Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 11413351 2037-01-05 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 12083182 2037-01-05 U-4425 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 12156917 2037-01-05 U-4425 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 12239689 2037-01-05 U-4425 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-002 12377133 2042-11-12 U-4425 Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 8906847 2031-04-30 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 10835578 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 11154593 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 11224661 2037-01-05 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 11311604 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 11389510 2037-01-05 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 11389511 2037-01-05 U-4425 Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 11413351 2037-01-05 Drug substance, Drug product 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 12083182 2037-01-05 U-4425 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 12156917 2037-01-05 U-4425 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 12239689 2037-01-05 U-4425 2026-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219164-003 12377133 2042-11-12 U-4425 Drug product 2026-03-16 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219164-001 8906847 2031-04-30 U-4425 Drug substance, Drug product 2026-03-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219164-001 10835578 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219164-001 11154593 2037-01-05 U-4425 Drug substance, Drug product 2026-03-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219164-001 11224661 2037-01-05 Drug substance, Drug product 2026-03-16 a50c72e98297…
Observed Orange Book exclusivity history# 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 Identifier FDA.report destination 2739524 Internal RxNorm lookup 2739529 Internal RxNorm lookup 2739531 Internal RxNorm lookup 2739533 Internal RxNorm lookup 2739535 Internal RxNorm lookup 2739537 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73362-203-01 Yuviwel 4 in 1 CARTON KIT 4 4 73362-203-02 Yuviwel 1 in 1 BOX KIT 1 4 73362-207-01 Yuviwel 1 in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 1 5.5 mg 4
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Yuviwel NAVEPEGRITIDE Ascendis Pharma Endocrinology, Inc. e01c1197-338f-414c-b804-808e129ebc8c 2026-03-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 219164 application number: NDA219164 ndc (product): 73362-203
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73362-203-01 73362020301 4 BOX in 1 CARTON (73362-203-01) / 1 KIT in 1 BOX (73362-203-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (73362-207-01) * 1 SOLUTION in 1 SYRINGE, GLASS (73362-801-01) 4 box 2026-02-27 No No Current 73362-203-02 73362020302 1 in 1 BOX Historical 73362-207-01 73362020701 1 in 1 VIAL, GLASS Historical