Home NDC 51754-1007 ELCYS
Product NDC 51754-1007
11-digit product format 517541007
Labeler code 51754
Product ID 51754-1007_04b033f6-7334-4aed-930f-beb3c349f193
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 2019-05-28
Substance CYSTEINE HYDROCHLORIDE
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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…
Additional Listing Data#
Finished product Yes
Brand name base ELCYS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYSTEINE HYDROCHLORIDE 10 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 1667993 Internal RxNorm lookup 2169281 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 51754-1007-1 ELCYS 10 mL in 1 VIAL INJECTION, SOLUTION 10 3 51754-1007-3 ELCYS 100 mL in 1 CARTON INJECTION, SOLUTION 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-1007 ELCYS (CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20240202_e7652275-1c53-490c-82ad-e63867df5788.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51754-1007-1 51754100701 10 mL in 1 VIAL (51754-1007-1) 10 ml 2019-05-28 0000-00-00 No No Current 51754-1007-3 51754100703 100 mL in 1 CARTON (51754-1007-3) 100 ml 2019-05-28 0000-00-00 No No Current