Home NDC 73129-001 Nulibry
Product NDC 73129-001
11-digit product format 731290001
Labeler code 73129
Product ID 73129-001_763981b6-9ee5-4e66-9e99-b7022fb0eaaf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fosdenopterin hydrobromide
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Origin Biosciences, Inc.
Application NDA214018
Marketing category NDA
Marketing start 2021-03-30
Marketing end 0000-00-00
Substance FOSDENOPTERIN HYDROBROMIDE
Active strength 10 mg/1
Pharmacologic classes Cyclic Pyranopterin Monophosphate [EPC], Cyclic Pyranopterin Monophosphate [EXT]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N214018-001 NULIBRY FOSDENOPTERIN HYDROBROMIDE EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214018-001 7504095 2029-04-09 U-3092 Drug product 2021-03-23
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214018-001 NCE 2026-02-26 N214018-001 ODE-342 2028-02-26
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 2026-02-19 14:30 UTC 2026-02 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 a50c72e98297…
Observed Orange Book patent history# 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 N214018-001 7504095 2029-04-09 U-3092 Drug product 2021-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214018-001 7504095 2029-04-09 U-3092 Drug product 2021-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214018-001 7504095 2029-04-09 U-3092 Drug product 2021-03-23 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 88 observed states.
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 Nulibry FOSDENOPTERIN HYDROBROMIDE Sentynl Therapeutics, Inc. 736aeea3-f206-454d-95d0-fd30964e8aab 2026-05-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 214018 application number: NDA214018
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 73129-001-01 73129000101 1 VIAL, SINGLE-DOSE in 1 CARTON (73129-001-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2021-03-30 0000-00-00 No No Current 73129-001-99 73129000199 1 VIAL, SINGLE-DOSE in 1 CARTON (73129-001-99) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2021-03-30 0000-00-00 Yes No Current