Home NDC 51754-1008 ELCYS
Product NDC 51754-1008
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 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 · 58 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 2026-02-19 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…2020-12-22 03:56 UTC 2020-12 N210660-001 ELCYS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210660-001 ELCYS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210660-001 ELCYS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210660-001 ELCYS 500MG/10ML (50MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-04-16 b00525d2431f…
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 12 · 451 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 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…2026-02-19 14:30 UTC 2026-02 N210660-001 11510941 2039-01-15 Drug product 2022-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210660-001 11510942 2039-01-15 U-2752 Drug product 2022-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210660-001 11642370 2039-01-15 Drug product 2023-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210660-001 11648262 2039-01-15 Drug product 2023-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210660-001 11679125 2039-01-15 Drug product 2023-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210660-001 11684636 2039-01-15 Drug product 2023-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210660-001 11826383 2039-01-15 Drug product 2023-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210660-001 11969439 2039-01-15 U-2752 2024-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 10478453 2039-01-15 U-2752 Drug product 2019-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 10583155 2039-01-15 U-2752 Drug product 2020-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 10653719 2039-01-15 Drug product 2020-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 10905713 2039-01-15 Drug product 2021-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 10905714 2039-01-15 Drug product 2021-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 10912795 2039-01-15 Drug product 2021-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 10918662 2039-01-15 Drug product 2021-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 10933089 2039-01-15 Drug product 2021-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 11510941 2039-01-15 Drug product 2022-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 11510942 2039-01-15 U-2752 Drug product 2022-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 11642370 2039-01-15 Drug product 2023-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 11648262 2039-01-15 Drug product 2023-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 11679125 2039-01-15 Drug product 2023-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 11684636 2039-01-15 Drug product 2023-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 11826383 2039-01-15 Drug product 2023-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210660-001 11969439 2039-01-15 U-2752 2024-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210660-001 10478453 2039-01-15 U-2752 Drug product 2019-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210660-001 10583155 2039-01-15 U-2752 Drug product 2020-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210660-001 10653719 2039-01-15 Drug product 2020-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210660-001 10905713 2039-01-15 Drug product 2021-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210660-001 10905714 2039-01-15 Drug product 2021-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210660-001 10912795 2039-01-15 Drug product 2021-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210660-001 10918662 2039-01-15 Drug product 2021-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210660-001 10933089 2039-01-15 Drug product 2021-03-02 6a471c1ec25d…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51754-1008-1 51754100801 1 VIAL in 1 CARTON (51754-1008-1) / 50 mL in 1 VIAL 1 vial 2024-01-01 No No Current 51754-1008-4 51754100804 25 VIAL in 1 CARTON (51754-1008-4) / 50 mL in 1 VIAL 25 vial 2024-01-01 No No Current