Home NDC 0338-9645 CYSTEINE HYDROCHLORIDE
Product NDC 0338-9645
11-digit product format 003389645
Labeler code 0338
Product ID 0338-9645_26874b67-a94f-46fd-82de-0b44b93d3db4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cysteine hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA212535
Marketing category NDA
Marketing start 2022-04-29
Substance CYSTEINE HYDROCHLORIDE
Active strength 34.5 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 · 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 Product TE source text 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…
Additional Listing Data#
Finished product Yes
Brand name base CYSTEINE HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYSTEINE HYDROCHLORIDE 34.5 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1667993 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 0338-9645-01 CYSTEINE HYDROCHLORIDE 10 mL in 1 VIAL, SINGLE-DOSE INJECTION 10 5 0338-9645-01 CYSTEINE HYDROCHLORIDE 5 in 1 CARTON INJECTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-9645 CYSTEINE HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION] 4 Current NDC, Legacy NDC, 2 package rows 20250315_cbf70fc3-14b3-4c17-8de8-acba1e12ac95.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0338-9645-01 00338964501 5 VIAL, SINGLE-DOSE in 1 CARTON (0338-9645-01) / 10 mL in 1 VIAL, SINGLE-DOSE 2022-04-29 0000-00-00 No No Current