Cisatracurium Besylate

Product NDC
0703-2045
Requested package NDC
0703-2045-03
11-digit product format
007032045
Labeler code
0703
Product ID
0703-2045_03d8934d-8294-48ae-b46f-a84b0bf44407
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium Besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA204960
Marketing category
ANDA
Marketing start
2018-09-04
Marketing end
0000-00-00
Substance
CISATRACURIUM BESYLATE
Active strength
200 mg/20mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0703-20450703-2045-03DDiscontinued by firm2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0703-20450703-2045-03DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0703-20450703-2045-03DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREECISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2017-01-27
A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREECISATRACURIUM BESYLATEEQ 10MG BASE/MLINJECTABLE / INJECTION2017-09-19
A204960-003CISATRACURIUM BESYLATECISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2017-08-30

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 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTION2017-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTION2017-09-19caaa826d4ba7…
2026-08-18 06:07:402026-07A204960-003CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2017-08-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204960-003CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-003CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204960-003CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-003CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204960-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2017-09-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204960-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2017-01-274b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204960-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204960-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204960-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204960-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204960-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204960-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204960-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204960-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204960-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204960-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204960-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204960-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204960-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204960-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204960-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204960-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204960-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204960-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204960-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204960-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204960-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204960-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204960-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204960-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204960-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204960-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204960-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204960-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204960-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204960-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204960-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204960-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204960-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204960-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204960-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204960-002AP174a2ff9319b5…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-2045-03ML - Milliliter0703-2045bb8c9cc1-bbf3-4a9e-b0a7-4ede478b971612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0703-2045CISATRACURIUM 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
0703-2045-030070320450310 CARTON in 1 BOX (0703-2045-03) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 20 mL in 1 VIAL, SINGLE-DOSE10 carton2018-09-040000-00-00NoNoCurrent