Home NDC 0409-1105 Atracurium Besylate
Product NDC 0409-1105
11-digit product format 004091105
Labeler code 0409
Product ID 0409-1105_926d60c7-8585-42f2-a9fc-02fcb51dc2ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ATRACURIUM BESYLATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA090761
Marketing category ANDA
Marketing start 2013-05-29
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 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 A090761-001 ATRACURIUM BESYLATE ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090761-001 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 · 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 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090761-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-10-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 0409-1105-02 Atracurium Besylate 10 in 1 CARTON INJECTION, SOLUTION 10 12 0409-1105-22 Atracurium Besylate 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 10 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATRACURIUM BESYLATE ACTIVE INGREDIENT 40AX66P76P ATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.] 1 ATRACURIUM ACTIVE MOIETY 2GQ1IRY63P ATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.] 1 BENZENESULFONIC ACID INACTIVE INGREDIENT 685928Z18A ATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH ATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1105 ATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20231125_de1c2dcd-295b-47ce-b7a1-a8be59939a54.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 Units Marketing start Marketing end Sample Exclude flag Status 0409-1105-02 00409110502 10 VIAL, MULTI-DOSE in 1 CARTON (0409-1105-02) / 10 mL in 1 VIAL, MULTI-DOSE (0409-1105-22) 2013-05-29 0000-00-00 No No Current 0409-1105-22 00409110522 10 mL in 1 VIAL, MULTI-DOSE 10 ml Historical