Nouress

Product NDC: 76014-006
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	76014-006		I	Inactivated by FDA		2026-08-10
excluded package	package	76014-006	76014-006-05	I	Inactivated by FDA		2026-08-10

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76014-006-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76014-006-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76014-006-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76014-006-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76014-006-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76014-006-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76014-006-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76014-006-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76014-006-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76014-006-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76014-006-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76014-006-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76014-006-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76014-006-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76014-006-05	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76014-006-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76014-006-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76014-006-05	`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	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#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76014-006-05	2022-01-28	C162847	48780-1	d6a99b39-a065-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use NOURESS™ safely and effectively. See full prescribing information for NOURESS. NOURESS (cysteine hydrochloride injection), for intravenous use Initial U.S. Approval: 1971

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYSTEINE HYDROCHLORIDE	CYSTEINE HYDROCHLORIDE	Baxter Healthcare Corporation	cbf70fc3-14b3-4c17-8de8-acba1e12ac95	2022-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212535 application number: NDA212535

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZT934N0X4W	CYSTEINE HYDROCHLORIDE	7048-04-6	CYSTEINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1667993	cysteine HCl 0.5 GM in 10 ML (50 MG/ML) Injection	PSN	627cc059-4124-49b3-a3d3-2eb3ed918bc7	1
2286589	NOURESS 500 MG in 10 ML Injection	PSN	627cc059-4124-49b3-a3d3-2eb3ed918bc7	1
2286589	10 ML cysteine hydrochloride 50 MG/ML Injection [Nouress]	SBD	627cc059-4124-49b3-a3d3-2eb3ed918bc7	1
1667993	10 ML cysteine hydrochloride 50 MG/ML Injection	SCD	627cc059-4124-49b3-a3d3-2eb3ed918bc7	1
1667993	cysteine HCl 0.5 GM per 10 ML Injection	SY	627cc059-4124-49b3-a3d3-2eb3ed918bc7	1
2286589	Nouress 50 MG (equivalent to cysteine 34.5 MG) per 1 ML Injection	SY	627cc059-4124-49b3-a3d3-2eb3ed918bc7	1
2286589	Nouress 50 MG/ML per 10 ML Injection	SY	627cc059-4124-49b3-a3d3-2eb3ed918bc7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	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
76014-006-33	76014000633	10 mL in 1 VIAL, SINGLE-USE	10 ml					Historical