Home NDC 42358-295 Nulibry
Product NDC 42358-295
11-digit product format 423580295
Labeler code 42358
Product ID 42358-295_cb790c3a-2ee7-4712-8e98-dc3748aad320
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fosdenopterin hydrobromide
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Sentynl Therapeutics, Inc.
Application NDA214018
Marketing category NDA
Marketing start 2021-03-30
Substance FOSDENOPTERIN HYDROBROMIDE
Active strength 9.5 mg/1
Pharmacologic classes Cyclic Pyranopterin Monophosphate [EPC], Cyclic Pyranopterin Monophosphate [EXT]
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 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 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 2026-09-14 22:38:34 2026-08 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 caaa826d4ba7…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 2026-09-14 22:38:34 2026-08 N214018-001 7504095 2029-04-09 U-3092 Drug product 2021-03-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214018-001 7504095 2029-04-09 U-3092 Drug product 2021-03-23 caaa826d4ba7…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 · 92 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 Nulibry
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOSDENOPTERIN HYDROBROMIDE 9.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X41B5W735T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2531292 Internal RxNorm lookup 2531297 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 42358-295-01 Nulibry 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 3 42358-295-01 Nulibry 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42358-295 NULIBRY (FOSDENOPTERIN HYDROBROMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SENTYNL THERAPEUTICS, INC.] 3 Current NDC, 2 package rows 20230412_736aeea3-f206-454d-95d0-fd30964e8aab.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.
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 ndc (product): 42358-295
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42358-295-01 42358029501 1 VIAL, SINGLE-DOSE in 1 CARTON (42358-295-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2022-10-28 No No Current