ELCYS

Product NDC: 51754-1008
Requested package NDC: 51754-1008-4
11-digit product format: 517541008
Labeler code: 51754
Product ID: 51754-1008_5e7be8d4-66c2-4bab-849f-46eaac9996cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cysteine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Exela Pharma Sciences, LLC
Application: NDA210660
Marketing category: NDA
Marketing start: 2023-12-12
Substance: CYSTEINE HYDROCHLORIDE
Active strength: 50 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51754-1008	51754-1008-4	D	Discontinued by firm		2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210660-001	ELCYS	CYSTEINE HYDROCHLORIDE	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16
N210660-002	ELCYS	CYSTEINE HYDROCHLORIDE	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-12-04

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210660-001	10478453	2039-01-15	U-2752	Drug product	2019-11-19
N210660-001	10583155	2039-01-15	U-2752	Drug product	2020-03-10
N210660-001	10653719	2039-01-15		Drug product	2020-07-02
N210660-001	10905713	2039-01-15		Drug product	2021-02-02
N210660-001	10905714	2039-01-15		Drug product	2021-02-02
N210660-001	10912795	2039-01-15		Drug product	2021-02-09
N210660-001	10918662	2039-01-15		Drug product	2021-02-16
N210660-001	10933089	2039-01-15		Drug product	2021-03-02
N210660-001	11510941	2039-01-15		Drug product	2022-12-06
N210660-001	11510942	2039-01-15	U-2752	Drug product	2022-12-06
N210660-001	11642370	2039-01-15		Drug product	2023-06-06
N210660-001	11648262	2039-01-15		Drug product	2023-06-06
N210660-001	11679125	2039-01-15		Drug product	2023-06-23
N210660-001	11684636	2039-01-15		Drug product	2023-07-03
N210660-001	11826383	2039-01-15		Drug product	2023-12-06
N210660-001	11969439	2039-01-15	U-2752		2024-05-29

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.

Product history page 1 of 2 · 62 observed 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	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210660-002	ELCYS	2500MG/50ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD	2023-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210660-001	ELCYS	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-16	`5aa47cf7b7d7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210660-001	AP	1	`5c6f7cd8ea54…`
2022-09-29 23:25 UTC	2022-09	N210660-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210660-001	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 483 observed states.

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	N210660-001	10478453	2039-01-15	U-2752	Drug product	2019-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10583155	2039-01-15	U-2752	Drug product	2020-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10653719	2039-01-15		Drug product	2020-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10905713	2039-01-15		Drug product	2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10905714	2039-01-15		Drug product	2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10912795	2039-01-15		Drug product	2021-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10918662	2039-01-15		Drug product	2021-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	10933089	2039-01-15		Drug product	2021-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11510941	2039-01-15		Drug product	2022-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11510942	2039-01-15	U-2752	Drug product	2022-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11642370	2039-01-15		Drug product	2023-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11648262	2039-01-15		Drug product	2023-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11679125	2039-01-15		Drug product	2023-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11684636	2039-01-15		Drug product	2023-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11826383	2039-01-15		Drug product	2023-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210660-001	11969439	2039-01-15	U-2752		2024-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210660-001	10478453	2039-01-15	U-2752	Drug product	2019-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10583155	2039-01-15	U-2752	Drug product	2020-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10653719	2039-01-15		Drug product	2020-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10905713	2039-01-15		Drug product	2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10905714	2039-01-15		Drug product	2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10912795	2039-01-15		Drug product	2021-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10918662	2039-01-15		Drug product	2021-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	10933089	2039-01-15		Drug product	2021-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	11510941	2039-01-15		Drug product	2022-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	11510942	2039-01-15	U-2752	Drug product	2022-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	11642370	2039-01-15		Drug product	2023-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	11648262	2039-01-15		Drug product	2023-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	11679125	2039-01-15		Drug product	2023-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	11684636	2039-01-15		Drug product	2023-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	11826383	2039-01-15		Drug product	2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210660-001	11969439	2039-01-15	U-2752		2024-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210660-001	10478453	2039-01-15	U-2752	Drug product	2019-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210660-001	10583155	2039-01-15	U-2752	Drug product	2020-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210660-001	10653719	2039-01-15		Drug product	2020-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210660-001	10905713	2039-01-15		Drug product	2021-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210660-001	10905714	2039-01-15		Drug product	2021-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210660-001	10912795	2039-01-15		Drug product	2021-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210660-001	10918662	2039-01-15		Drug product	2021-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210660-001	10933089	2039-01-15		Drug product	2021-03-02	`011fe1cb6892…`

Additional Listing Data#

Finished product: Yes
Brand name base: ELCYS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYSTEINE HYDROCHLORIDE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ZT934N0X4W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1486165	Internal RxNorm lookup
2671585	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
52317b38-b2e6-4a1c-b5b0-43cada0d205e	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51754-1008-1	ELCYS	50 mL in 1 VIAL	INJECTION, SOLUTION	50	3
51754-1008-1	ELCYS	1 in 1 CARTON	INJECTION, SOLUTION	1	3
51754-1008-4	ELCYS	25 in 1 CARTON	INJECTION, SOLUTION	25	2
51754-1008-4	ELCYS	50 mL in 1 VIAL	INJECTION, SOLUTION	50	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51754-1008	ELCYS (CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]	2	Current NDC, 2 package rows	20240202_9a52ae2f-1cea-4ad5-a074-66bbf06578d3.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ELCYS	CYSTEINE HYDROCHLORIDE	Exela Pharma Sciences, LLC	52317b38-b2e6-4a1c-b5b0-43cada0d205e	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210660 application number: NDA210660 ndc (product): 51754-1008
ELCYS	CYSTEINE HYDROCHLORIDE	Exela Pharma Sciences, LLC	e7652275-1c53-490c-82ad-e63867df5788	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210660 application number: NDA210660

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
1486165	cysteine HCl 50 MG/ML Injectable Solution	PSN	52317b38-b2e6-4a1c-b5b0-43cada0d205e	3
2671585	ELCYS 50 MG/ML Injectable Solution	PSN	52317b38-b2e6-4a1c-b5b0-43cada0d205e	3
2671585	cysteine hydrochloride 50 MG/ML Injectable Solution [Elcys]	SBD	52317b38-b2e6-4a1c-b5b0-43cada0d205e	3
1486165	cysteine hydrochloride 50 MG/ML Injectable Solution	SCD	52317b38-b2e6-4a1c-b5b0-43cada0d205e	3
2671585	Elcys 50 MG/ML Injectable Solution	SY	52317b38-b2e6-4a1c-b5b0-43cada0d205e	3
1486165	cysteine HCl 50 MG/ML Injectable Solution	PSN	9a52ae2f-1cea-4ad5-a074-66bbf06578d3	2
2671585	ELCYS 50 MG/ML Injectable Solution	PSN	9a52ae2f-1cea-4ad5-a074-66bbf06578d3	2
2671585	cysteine hydrochloride 50 MG/ML Injectable Solution [Elcys]	SBD	9a52ae2f-1cea-4ad5-a074-66bbf06578d3	2
1486165	cysteine hydrochloride 50 MG/ML Injectable Solution	SCD	9a52ae2f-1cea-4ad5-a074-66bbf06578d3	2
2671585	Elcys 50 MG/ML Injectable Solution	SY	9a52ae2f-1cea-4ad5-a074-66bbf06578d3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51754-1008-4	51754100804	25 VIAL in 1 CARTON (51754-1008-4) / 50 mL in 1 VIAL	25 vial	2024-01-01	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ELCYS	Exela Pharma Sciences, LLC	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	3
ELCYS	Exela Pharma Sciences, LLC	2024-02-01	HUMAN PRESCRIPTION DRUG LABEL	2