Cisatracurium Besylate

Product NDC
0703-2056
11-digit product format
007032056
Labeler code
0703
Product ID
0703-2056_03d8934d-8294-48ae-b46f-a84b0bf44407
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium Besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA209334
Marketing category
ANDA
Marketing start
2018-09-04
Marketing end
0000-00-00
Substance
CISATRACURIUM BESYLATE
Active strength
20 mg/10mL
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0703-2056DDiscontinued by firm2026-10-05
excluded packagepackage0703-20560703-2056-03DDiscontinued by firm2026-10-05

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0703-2056-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0703-2056-03f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog.

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-303f01610625f2…
2019-09-15 20:21 UTC2019-09A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209334-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209334-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209334-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209334-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209334-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209334-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209334-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209334-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209334-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209334-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209334-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209334-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209334-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209334-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209334-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209334-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209334-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209334-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A209334-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209334-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209334-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209334-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A209334-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209334-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209334-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209334-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209334-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209334-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209334-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209334-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209334-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209334-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209334-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209334-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209334-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209334-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209334-001AP1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-2056-03ML - Milliliter0703-205625fe7975-5afa-4d19-9a90-f0c123e3569312018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0703-2056CISATRACURIUM BESYLATE INJECTION [TEVA PARENTERAL MEDICINES, INC.]25Legacy NDC20241228_c6e6823b-fa28-4da2-b3f4-9ad0f92782ce.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0703-2056-030070320560310 CARTON in 1 BOX (0703-2056-03) > 1 VIAL, MULTI-DOSE in 1 CARTON > 10 mL in 1 VIAL, MULTI-DOSE10 carton2018-09-040000-00-00NoNoCurrent