cisatracurium besylate

Product NDC
0781-9039
11-digit product format
007819039
Labeler code
0781
Product ID
0781-9039_a0b53421-7a25-4d66-9426-7ae7e9a98e3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cisatracurium besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA200154
Marketing category
ANDA
Marketing start
2013-02-28
Marketing end
2020-12-31
Substance
CISATRACURIUM 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

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 productproduct0781-9039DDiscontinued by firm2026-08-17
excluded packagepackage0781-90390781-9039-95DDiscontinued 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 · 24 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 packagepackage0781-9039-95d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-9039-95f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-9039-952ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-9039-95a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-9039-95cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-9039-95cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-9039-95302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-9039-95ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-9039-950efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-9039-95ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-9039-95367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-9039-95557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREECISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03
A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREECISATRACURIUM BESYLATEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A200154-001AP
A200154-002AP

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03caaa826d4ba7…
2026-08-18 06:07:402026-07A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200154-001CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200154-002CISATRACURIUM BESYLATE PRESERVATIVE FREEEQ 10MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03bb7c543d1eb4…

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
2026-08-18 06:07:402026-07A200154-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A200154-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200154-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200154-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200154-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200154-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200154-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200154-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200154-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200154-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200154-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200154-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200154-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200154-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200154-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200154-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200154-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200154-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200154-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200154-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200154-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200154-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200154-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200154-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200154-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200154-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200154-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200154-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200154-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200154-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200154-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200154-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200154-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200154-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200154-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200154-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200154-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200154-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200154-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200154-002AP1bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-9039-95ML - Milliliter0781-90398cadb311-6964-491e-8038-7b06ecd9d2a612013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CISATRACURIUM BESYLATEACTIVE INGREDIENT80YS8O1MBSCISATRACURIUM BESYLATE INJECTION [SANDOZ INC]1
CISATRACURIUMACTIVE MOIETYQX62KLI41NCISATRACURIUM BESYLATE INJECTION [SANDOZ INC]1
BENZENESULFONIC ACIDINACTIVE INGREDIENT685928Z18ACISATRACURIUM BESYLATE INJECTION [SANDOZ INC]1
WATERINACTIVE INGREDIENT059QF0KO0RCISATRACURIUM BESYLATE INJECTION [SANDOZ INC]1

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cisatracurium besylateCISATRACURIUM BESYLATESandoz Inc291a55dd-ab45-4660-b513-4ecb729eb0512024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200154
application number: ANDA200154