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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76014-00676014-006-05IInactivated by FDA2026-08-10

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N212535-001NOURESSCYSTEINE HYDROCHLORIDE500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N212535-001104784532039-01-15U-2752Drug product2020-07-28
N212535-001105831552039-01-15U-2752Drug product2020-07-28
N212535-001106537192039-01-15Drug product2020-07-28
N212535-001109057132039-01-15Drug product2021-03-04
N212535-001109057142039-01-15Drug product2021-03-04
N212535-001109127952039-01-15Drug product2021-03-04
N212535-001109186622039-01-15Drug product2021-03-04
N212535-001109330892039-01-15Drug product2021-03-29
N212535-001115109422039-01-15U-2752Drug product2023-03-24
N212535-001116423702039-01-15Drug product2024-05-17
N212535-001116482622039-01-15Drug product2024-05-17
N212535-001116791252039-01-15Drug product2024-05-17
N212535-001116846362039-01-15Drug product2024-05-17
N212535-001118263832039-01-15Drug product2024-05-17
N212535-001125695142039-01-15Drug product2026-06-25
N212535-001115109412039-03-02Drug product2023-03-24
N212535-001104930512039-03-15Drug product2020-01-29
N212535-001105431862039-03-15U-27222020-01-29
N212535-001107024902039-03-15Drug product2020-08-04
N212535-001110454382039-03-15Drug product2021-08-05

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-134b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-1387673890dc5c…
2021-03-12 10:30 UTC2021-03N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-133f0d92c62455…
2023-05-13 08:27 UTC2023-05N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13053a50430f4f…
2023-01-26 05:58 UTC2023-01N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212535-001NOURESS500MG/10ML (50MG/ML)SOLUTION / INTRAVENOUSRLD2019-12-13a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 14 · 542 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N212535-001104784532039-01-15U-2752Drug product2020-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001105831552039-01-15U-2752Drug product2020-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001106537192039-01-15Drug product2020-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001109057132039-01-15Drug product2021-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001109057142039-01-15Drug product2021-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001109127952039-01-15Drug product2021-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001109186622039-01-15Drug product2021-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001109330892039-01-15Drug product2021-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001115109422039-01-15U-2752Drug product2023-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001116423702039-01-15Drug product2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001116482622039-01-15Drug product2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001116791252039-01-15Drug product2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001116846362039-01-15Drug product2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001118263832039-01-15Drug product2024-05-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001115109412039-03-02Drug product2023-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001104930512039-03-15Drug product2020-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001105431862039-03-15U-27222020-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001107024902039-03-15Drug product2020-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212535-001110454382039-03-15Drug product2021-08-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001104784532039-01-15U-2752Drug product2020-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001105831552039-01-15U-2752Drug product2020-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001106537192039-01-15Drug product2020-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001109057132039-01-15Drug product2021-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001109057142039-01-15Drug product2021-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001109127952039-01-15Drug product2021-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001109186622039-01-15Drug product2021-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001109330892039-01-15Drug product2021-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001115109422039-01-15U-2752Drug product2023-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001116423702039-01-15Drug product2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001116482622039-01-15Drug product2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001116791252039-01-15Drug product2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001116846362039-01-15Drug product2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001118263832039-01-15Drug product2024-05-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001115109412039-03-02Drug product2023-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001104930512039-03-15Drug product2020-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001105431862039-03-15U-27222020-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001107024902039-03-15Drug product2020-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212535-001110454382039-03-15Drug product2021-08-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N212535-001104784532039-01-15U-2752Drug product2020-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212535-001105831552039-01-15U-2752Drug product2020-07-286a471c1ec25d…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76014-006-05Nouress5 in 1 CARTONINJECTION51
76014-006-33Nouress10 mL in 1 VIAL, SINGLE-USEINJECTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76014-006NOURESS (CYSTEINE HYDROCHLORIDE) INJECTION [AVADEL LEGACY PHARMACEUTICALS, LLC]1Legacy NDC, 2 package rows20200401_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYSTEINE HYDROCHLORIDECYSTEINE HYDROCHLORIDEBaxter Healthcare Corporationcbf70fc3-14b3-4c17-8de8-acba1e12ac952022-04-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 212535
application number: NDA212535

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1667993cysteine HCl 0.5 GM in 10 ML (50 MG/ML) InjectionPSN627cc059-4124-49b3-a3d3-2eb3ed918bc71
2286589NOURESS 500 MG in 10 ML InjectionPSN627cc059-4124-49b3-a3d3-2eb3ed918bc71
228658910 ML cysteine hydrochloride 50 MG/ML Injection [Nouress]SBD627cc059-4124-49b3-a3d3-2eb3ed918bc71
166799310 ML cysteine hydrochloride 50 MG/ML InjectionSCD627cc059-4124-49b3-a3d3-2eb3ed918bc71
1667993cysteine HCl 0.5 GM per 10 ML InjectionSY627cc059-4124-49b3-a3d3-2eb3ed918bc71
2286589Nouress 50 MG (equivalent to cysteine 34.5 MG) per 1 ML InjectionSY627cc059-4124-49b3-a3d3-2eb3ed918bc71
2286589Nouress 50 MG/ML per 10 ML InjectionSY627cc059-4124-49b3-a3d3-2eb3ed918bc71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76014-006-05760140006055 VIAL, SINGLE-USE in 1 CARTON (76014-006-05) > 10 mL in 1 VIAL, SINGLE-USE (76014-006-33) 2020-04-010000-00-00NoNoCurrent