Home NDC 25021-672-10 Atracurium Besylate
Product NDC 25021-672
Requested package NDC 25021-672-10
11-digit product format 250210672
Labeler code 25021
Product ID 25021-672_0b4ea4ae-d3aa-41b9-a567-4f57f356b1fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atracurium besylate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA091489
Marketing category ANDA
Marketing start 2012-05-01
Marketing end 2022-09-30
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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A091489-001 ATRACURIUM BESYLATE 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 A091489-001 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 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091489-001 ATRACURIUM BESYLATE 10MG/ML INJECTABLE / INJECTION AP 2012-02-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091489-001 ATRACURIUM BESYLATE 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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded atracurium besylate ACTIVE INGREDIENT 40AX66P76P ATRACURIUM BESYLATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 7 atracurium ACTIVE MOIETY 2GQ1IRY63P ATRACURIUM BESYLATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 7 benzenesulfonic acid INACTIVE INGREDIENT 685928Z18A ATRACURIUM BESYLATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 7 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH ATRACURIUM BESYLATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 7 water INACTIVE INGREDIENT 059QF0KO0R ATRACURIUM BESYLATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 7 atracurium besylate ACTIVE INGREDIENT 40AX66P76P ATRACURIUM BESYLATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 atracurium ACTIVE MOIETY 2GQ1IRY63P ATRACURIUM BESYLATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 benzenesulfonic acid INACTIVE INGREDIENT 685928Z18A ATRACURIUM BESYLATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH ATRACURIUM BESYLATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2 water INACTIVE INGREDIENT 059QF0KO0R ATRACURIUM BESYLATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 2
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25021-672-10 25021067210 10 VIAL in 1 CARTON (25021-672-10) > 10 mL in 1 VIAL 10 vial 2012-05-01 2022-09-30 No No Current