Home NDC 55150-217 Atracurium Besylate
Product NDC 55150-217
11-digit product format 551500217
Labeler code 55150
Product ID 55150-217_12db80ae-2d05-4941-8c95-8ff454a31d80
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atracurium Besylate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler AuroMedics Pharma LLC
Application ANDA206011
Marketing category ANDA
Marketing start 2015-04-08
Substance ATRACURIUM BESYLATE
Active strength 100 mg/10mL
Pharmacologic classes Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
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 42 .
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 A206011-001 ATRACURIUM BESYLATE ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION 2015-04-08
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 · 42 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 2026-08-18 06:07:40 2026-07 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION 2015-04-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION 2015-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION 2015-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION 2015-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206011-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2015-04-08 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Atracurium Besylate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATRACURIUM BESYLATE 100 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 40AX66P76P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 966768 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 55150-217-10 Atracurium Besylate 10 in 1 CARTON INJECTION, SOLUTION 10 5 55150-217-10 Atracurium Besylate 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-217 ATRACURIUM BESYLATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC] 5 Current NDC, Legacy NDC, 2 package rows 20220215_f7b6a720-05a7-4d6a-9200-21bdc90fc1c4.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 55150-217-10 55150021710 10 VIAL, MULTI-DOSE in 1 CARTON (55150-217-10) / 10 mL in 1 VIAL, MULTI-DOSE 2015-04-08 0000-00-00 No No Current