Home NDC 71288-701-05 Atracurium Besylate
Product NDC 71288-701
Requested package NDC 71288-701-05
11-digit product format 712880701
Labeler code 71288
Product ID 71288-701_2e0da959-ece2-4643-9b93-a1ce7d59efdd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atracurium Besylate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA091488
Marketing category ANDA
Marketing start 2018-05-15
Substance ATRACURIUM BESYLATE
Active strength 10 mg/mL
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 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 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091488-001 AP
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 · 41 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 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091488-001 ATRACURIUM BESYLATE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 10 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 966768 Internal RxNorm lookup 1718913 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 71288-701-05 Atracurium Besylate 10 in 1 CARTON INJECTION, SOLUTION 10 5 71288-701-06 Atracurium Besylate 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-701 ATRACURIUM BESYLATE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20241206_efe90ee2-fe9e-421f-9e54-2961085d3b12.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 71288-701-05 71288070105 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-701-05) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-701-06) 2018-05-15 0000-00-00 No No Current