Home NDC 76014-006-05 Nouress
Product NDC 76014-006
Requested package NDC 76014-006-05
11-digit product format 760140006
Labeler code 76014
Product ID 76014-006_c52947e7-f655-4f78-844c-5b24edaa5fce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cysteine hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Avadel Legacy Pharmaceuticals, LLC
Application NDA212535
Marketing category NDA
Marketing start 2020-04-01
Marketing end 0000-00-00
Substance CYSTEINE HYDROCHLORIDE
Active strength 35 mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 N212535-001 NOURESS CYSTEINE HYDROCHLORIDE 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212535-001 10478453 2039-01-15 U-2752 Drug product 2020-07-28 N212535-001 10583155 2039-01-15 U-2752 Drug product 2020-07-28 N212535-001 10653719 2039-01-15 Drug product 2020-07-28 N212535-001 10905713 2039-01-15 Drug product 2021-03-04 N212535-001 10905714 2039-01-15 Drug product 2021-03-04 N212535-001 10912795 2039-01-15 Drug product 2021-03-04 N212535-001 10918662 2039-01-15 Drug product 2021-03-04 N212535-001 10933089 2039-01-15 Drug product 2021-03-29 N212535-001 11510942 2039-01-15 U-2752 Drug product 2023-03-24 N212535-001 11642370 2039-01-15 Drug product 2024-05-17 N212535-001 11648262 2039-01-15 Drug product 2024-05-17 N212535-001 11679125 2039-01-15 Drug product 2024-05-17 N212535-001 11684636 2039-01-15 Drug product 2024-05-17 N212535-001 11826383 2039-01-15 Drug product 2024-05-17 N212535-001 12569514 2039-01-15 Drug product 2026-06-25 N212535-001 11510941 2039-03-02 Drug product 2023-03-24 N212535-001 10493051 2039-03-15 Drug product 2020-01-29 N212535-001 10543186 2039-03-15 U-2722 2020-01-29 N212535-001 10702490 2039-03-15 Drug product 2020-08-04 N212535-001 11045438 2039-03-15 Drug product 2021-08-05
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 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212535-001 NOURESS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD 2019-12-13 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 14 · 542 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 N212535-001 10478453 2039-01-15 U-2752 Drug product 2020-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 10583155 2039-01-15 U-2752 Drug product 2020-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 10653719 2039-01-15 Drug product 2020-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 10905713 2039-01-15 Drug product 2021-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 10905714 2039-01-15 Drug product 2021-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 10912795 2039-01-15 Drug product 2021-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 10918662 2039-01-15 Drug product 2021-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 10933089 2039-01-15 Drug product 2021-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 11510942 2039-01-15 U-2752 Drug product 2023-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 11642370 2039-01-15 Drug product 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 11648262 2039-01-15 Drug product 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 11679125 2039-01-15 Drug product 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 11684636 2039-01-15 Drug product 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 11826383 2039-01-15 Drug product 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 11510941 2039-03-02 Drug product 2023-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 10493051 2039-03-15 Drug product 2020-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 10543186 2039-03-15 U-2722 2020-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 10702490 2039-03-15 Drug product 2020-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212535-001 11045438 2039-03-15 Drug product 2021-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 10478453 2039-01-15 U-2752 Drug product 2020-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 10583155 2039-01-15 U-2752 Drug product 2020-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 10653719 2039-01-15 Drug product 2020-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 10905713 2039-01-15 Drug product 2021-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 10905714 2039-01-15 Drug product 2021-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 10912795 2039-01-15 Drug product 2021-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 10918662 2039-01-15 Drug product 2021-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 10933089 2039-01-15 Drug product 2021-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 11510942 2039-01-15 U-2752 Drug product 2023-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 11642370 2039-01-15 Drug product 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 11648262 2039-01-15 Drug product 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 11679125 2039-01-15 Drug product 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 11684636 2039-01-15 Drug product 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 11826383 2039-01-15 Drug product 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 11510941 2039-03-02 Drug product 2023-03-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 10493051 2039-03-15 Drug product 2020-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 10543186 2039-03-15 U-2722 2020-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 10702490 2039-03-15 Drug product 2020-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212535-001 11045438 2039-03-15 Drug product 2021-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212535-001 10478453 2039-01-15 U-2752 Drug product 2020-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212535-001 10583155 2039-01-15 U-2752 Drug product 2020-07-28 6a471c1ec25d…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76014-006-05 Nouress 5 in 1 CARTON INJECTION 5 1 76014-006-33 Nouress 10 mL in 1 VIAL, SINGLE-USE INJECTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76014-006 NOURESS (CYSTEINE HYDROCHLORIDE) INJECTION [AVADEL LEGACY PHARMACEUTICALS, LLC] 1 Legacy NDC, 2 package rows 20200401_627cc059-4124-49b3-a3d3-2eb3ed918bc7.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 76014-006-05 76014000605 5 VIAL, SINGLE-USE in 1 CARTON (76014-006-05) > 10 mL in 1 VIAL, SINGLE-USE (76014-006-33) 2020-04-01 0000-00-00 No No Current