Home NDC 72786-111-02 OXBRYTA
Product NDC 72786-111
Requested package NDC 72786-111-02
11-digit product format 727860111
Labeler code 72786
Product ID 72786-111_e27a3e07-438e-49d3-aae3-095e9379c7b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Voxelotor
Dosage form TABLET, FOR SUSPENSION
Route ORAL
Labeler Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.
Application NDA216157
Marketing category NDA
Marketing start 2021-12-17
Substance VOXELOTOR
Active strength 300 mg/1
Pharmacologic classes Cytochrome P450 3A4 Inhibitors [MoA], Hemoglobin S Polymerization Inhibitor [EPC], Hemoglobin S Polymerization Inhibitors [MoA]
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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216157-001 OXBRYTA VOXELOTOR 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216157-001 10017491 2032-12-28 Drug product 2022-01-14 N216157-001 10034879 2032-12-28 Drug substance, Drug product 2022-01-14 N216157-001 10806733 2032-12-28 Drug substance 2022-01-14 N216157-001 9018210 2033-11-25 Drug substance, Drug product 2022-01-14 N216157-001 9248199 2034-01-29 U-2676 2022-01-14 N216157-001 9248199 2034-01-29 U-2715 2022-01-14 N216157-001 10722502 2035-02-06 Drug product 2022-01-14 N216157-001 11452720 2035-02-06 U-3459 2022-10-27 N216157-001 9447071 2035-02-06 Drug substance, Drug product 2022-01-14 N216157-001 11020382 2036-12-02 U-3133 2022-01-14 N216157-001 11020382 2036-12-02 U-3134 2022-01-14 N216157-001 11944612 2036-12-02 U-3893 2024-05-02
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216157-001 ODE* 2026-11-25 N216157-001 ODE-394 2028-12-17
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 2026-09-14 22:38:34 2026-08 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2021-12-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216157-001 OXBRYTA 300MG TABLET, FOR SUSPENSION / ORAL RLD 2021-12-17 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 10 · 384 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N216157-001 10017491 2032-12-28 Drug product 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216157-001 10034879 2032-12-28 Drug substance, Drug product 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216157-001 10806733 2032-12-28 Drug substance 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216157-001 9018210 2033-11-25 Drug substance, Drug product 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216157-001 9248199 2034-01-29 U-2676 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216157-001 9248199 2034-01-29 U-2715 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216157-001 10722502 2035-02-06 Drug product 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216157-001 11452720 2035-02-06 U-3459 2022-10-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216157-001 9447071 2035-02-06 Drug substance, Drug product 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216157-001 11020382 2036-12-02 U-3133 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216157-001 11020382 2036-12-02 U-3134 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216157-001 11944612 2036-12-02 U-3893 2024-05-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216157-001 10017491 2032-12-28 Drug product 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216157-001 10034879 2032-12-28 Drug substance, Drug product 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216157-001 10806733 2032-12-28 Drug substance 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216157-001 9018210 2033-11-25 Drug substance, Drug product 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216157-001 9248199 2034-01-29 U-2676 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216157-001 9248199 2034-01-29 U-2715 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216157-001 10722502 2035-02-06 Drug product 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216157-001 11452720 2035-02-06 U-3459 2022-10-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216157-001 9447071 2035-02-06 Drug substance, Drug product 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216157-001 11020382 2036-12-02 U-3133 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216157-001 11020382 2036-12-02 U-3134 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216157-001 11944612 2036-12-02 U-3893 2024-05-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216157-001 10017491 2032-12-28 Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216157-001 10034879 2032-12-28 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216157-001 10806733 2032-12-28 Drug substance 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216157-001 9018210 2033-11-25 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216157-001 9248199 2034-01-29 U-2676 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216157-001 9248199 2034-01-29 U-2715 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216157-001 10722502 2035-02-06 Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216157-001 11452720 2035-02-06 U-3459 2022-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216157-001 9447071 2035-02-06 Drug substance, Drug product 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216157-001 11020382 2036-12-02 U-3133 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216157-001 11020382 2036-12-02 U-3134 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216157-001 11944612 2036-12-02 U-3893 2024-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216157-001 10017491 2032-12-28 Drug product 2022-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216157-001 10034879 2032-12-28 Drug substance, Drug product 2022-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216157-001 10806733 2032-12-28 Drug substance 2022-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216157-001 9018210 2033-11-25 Drug substance, Drug product 2022-01-14 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 56 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base OXBRYTA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VOXELOTOR 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3ZO554A4Q8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2265683 Internal RxNorm lookup 2265689 Internal RxNorm lookup 2588070 Internal RxNorm lookup 2588074 Internal RxNorm lookup 2619427 Internal RxNorm lookup 2619428 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 72786-111-02 OXBRYTA 60 in 1 BOTTLE, PLASTIC TABLET, FOR SUSPENSION 60 13 72786-111-03 OXBRYTA 90 in 1 BOTTLE, PLASTIC TABLET, FOR SUSPENSION 90 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72786-111 OXBRYTA (VOXELOTOR) TABLET, FILM COATED OXBRYTA (VOXELOTOR) TABLET, FOR SUSPENSION [GLOBAL BLOOD THERAPEUTICS, INC, A SUBSIDIARY OF PFIZER INC.] 13 Current NDC, Legacy NDC, 2 package rows 20231227_3c557fac-29ec-483f-b691-8a935d4decc3.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 Marketing start Marketing end Sample Exclude flag Status 72786-111-02 72786011102 60 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC (72786-111-02) 2021-12-17 0000-00-00 No No Current