Home NDC 68135-082-36 VOXZOGO 0.4mg
Product NDC 68135-082
Requested package NDC 68135-082-36
11-digit product format 681350082
Labeler code 68135
Product ID 68135-082_6100caa6-4951-4773-b80c-6be0c04efd24
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vosoritide
Dosage form KIT
Labeler BioMarin Pharmaceutical Inc.
Application NDA214938
Marketing category NDA
Marketing start 2021-11-19
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N214938-001 VOXZOGO VOSORITIDE 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 N214938-002 VOXZOGO VOSORITIDE 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 N214938-003 VOXZOGO VOSORITIDE 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19
Orange Book patents# Current patent rows page 1 of 1 · 24 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214938-001 RE48267 2030-05-20 U-3927 2021-12-17 N214938-001 8198242 2035-06-11 U-3927 Drug substance, Drug product 2021-12-17 N214938-001 10646550 2036-08-01 U-3927 Drug product 2021-12-17 N214938-001 11590204 2036-08-01 U-3927 Drug product 2024-05-20 N214938-001 11911446 2036-08-01 U-3927 2024-05-20 N214938-001 12514906 2036-08-01 U-3927 Drug product 2026-02-03 N214938-001 9907834 2036-08-01 Drug product 2021-12-17 N214938-001 12233106 2042-07-11 U-3927 2025-03-21 N214938-002 RE48267 2030-05-20 U-3927 2021-12-17 N214938-002 8198242 2035-06-11 U-3927 Drug substance, Drug product 2021-12-17 N214938-002 10646550 2036-08-01 U-3927 Drug product 2021-12-17 N214938-002 11590204 2036-08-01 U-3927 Drug product 2024-05-20 N214938-002 11911446 2036-08-01 U-3927 2024-05-20 N214938-002 12514906 2036-08-01 U-3927 Drug product 2026-02-03 N214938-002 9907834 2036-08-01 Drug product 2021-12-17 N214938-002 12233106 2042-07-11 U-3927 2025-03-21 N214938-003 RE48267 2030-05-20 U-3927 2021-12-17 N214938-003 8198242 2035-06-11 U-3927 Drug substance, Drug product 2021-12-17 N214938-003 10646550 2036-08-01 U-3927 Drug product 2021-12-17 N214938-003 11590204 2036-08-01 U-3927 Drug product 2024-05-20 N214938-003 11911446 2036-08-01 U-3927 2024-05-20 N214938-003 12514906 2036-08-01 U-3927 Drug product 2026-02-03 N214938-003 9907834 2036-08-01 Drug product 2021-12-17 N214938-003 12233106 2042-07-11 U-3927 2025-03-21
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 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.
Product history page 1 of 3 · 99 observed 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 2026-02-19 14:30 UTC 2026-02 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214938-002 VOXZOGO 0.56MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214938-003 VOXZOGO 1.2MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214938-001 VOXZOGO 0.4MG/VIAL POWDER / SUBCUTANEOUS RLD, RS 2021-11-19 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 13 · 486 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214938-001 RE48267 2030-05-20 U-3927 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-001 8198242 2030-06-11 U-3927 Drug substance, Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-001 10646550 2036-08-01 U-3927 Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-001 11590204 2036-08-01 U-3927 Drug product 2024-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-001 11911446 2036-08-01 U-3927 2024-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-001 12514906 2036-08-01 U-3927 Drug product 2026-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-001 9907834 2036-08-01 Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-001 12233106 2042-07-11 U-3927 2025-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-002 RE48267 2030-05-20 U-3927 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-002 8198242 2030-06-11 U-3927 Drug substance, Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-002 10646550 2036-08-01 U-3927 Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-002 11590204 2036-08-01 U-3927 Drug product 2024-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-002 11911446 2036-08-01 U-3927 2024-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-002 12514906 2036-08-01 U-3927 Drug product 2026-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-002 9907834 2036-08-01 Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-002 12233106 2042-07-11 U-3927 2025-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-003 RE48267 2030-05-20 U-3927 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-003 8198242 2030-06-11 U-3927 Drug substance, Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-003 10646550 2036-08-01 U-3927 Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-003 11590204 2036-08-01 U-3927 Drug product 2024-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-003 11911446 2036-08-01 U-3927 2024-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-003 12514906 2036-08-01 U-3927 Drug product 2026-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-003 9907834 2036-08-01 Drug product 2021-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214938-003 12233106 2042-07-11 U-3927 2025-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-001 RE48267 2030-05-20 U-3927 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-001 8198242 2030-06-11 U-3927 Drug substance, Drug product 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-001 10646550 2036-08-01 U-3927 Drug product 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-001 11590204 2036-08-01 U-3927 Drug product 2024-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-001 11911446 2036-08-01 U-3927 2024-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-001 9907834 2036-08-01 Drug product 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-001 12233106 2042-07-11 U-3927 2025-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-002 RE48267 2030-05-20 U-3927 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-002 8198242 2030-06-11 U-3927 Drug substance, Drug product 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-002 10646550 2036-08-01 U-3927 Drug product 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-002 11590204 2036-08-01 U-3927 Drug product 2024-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-002 11911446 2036-08-01 U-3927 2024-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-002 9907834 2036-08-01 Drug product 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-002 12233106 2042-07-11 U-3927 2025-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-003 RE48267 2030-05-20 U-3927 2021-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214938-003 8198242 2030-06-11 U-3927 Drug substance, Drug product 2021-12-17 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 273 observed states.
Additional Listing Data#
Finished product Yes
Brand name base VOXZOGO 0.4mg
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2586364 Internal RxNorm lookup 2586369 Internal RxNorm lookup 2586371 Internal RxNorm lookup 2586373 Internal RxNorm lookup 2586375 Internal RxNorm lookup 2586377 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68135-061-00 VOXZOGO 0.4mg 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 0.4 mg in 0.5mL 16 68135-061-00 VOXZOGO 0.4mg 0.5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 mL 0.4 mg in 0.5mL 16 68135-082-36 VOXZOGO 0.4mg 1 in 1 CARTON KIT 1 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68135-082 VOXZOGO 0.4MG (VOSORITIDE) KIT VOXZOGO 0.56MG (VOSORITIDE) KIT VOXZOGO 1.2MG (VOSORITIDE) KIT [BIOMARIN PHARMACEUTICAL INC.] 15 Current NDC, Legacy NDC, 3 package rows 20241220_228e8560-04a4-4bb1-a81f-29531a9e4d27.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68135-082-36 68135008236 1 KIT in 1 CARTON (68135-082-36) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-061-00) / .5 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-070-12) 1 kit 2021-11-19 0000-00-00 No No Current