cisatracurium besylate

Product NDC
0781-3152
11-digit product format
007813152
Labeler code
0781
Product ID
0781-3152_bb1408b3-f751-45cd-84c9-3e5bff7dbdd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cisatracurium besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA200159
Marketing category
ANDA
Marketing start
2012-07-16
Substance
CISATRACURIUM BESYLATE
Active strength
2 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200159-001CISATRACURIUM BESYLATECISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200159-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-033f01610625f2…
2019-09-15 20:21 UTC2019-09A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200159-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2012-02-03e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A200159-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200159-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200159-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200159-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200159-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200159-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200159-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200159-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200159-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200159-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200159-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200159-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200159-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200159-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200159-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200159-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200159-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200159-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200159-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200159-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200159-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200159-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A200159-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200159-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200159-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200159-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A200159-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200159-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200159-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200159-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200159-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200159-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200159-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200159-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200159-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200159-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200159-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200159-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200159-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200159-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
cisatracurium besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CISATRACURIUM BESYLATE2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80YS8O1MBSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199211Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ee0358e-2cce-40d3-9fcf-1b9088815c98Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bde27158-d1b9-e941-8af6-709c63f1bc54Product name920200925
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3152-70cisatracurium besylate10 mL in 1 VIAL, MULTI-DOSEINJECTION106
0781-3152-95cisatracurium besylate10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3152-70ML - Milliliter0781-3152f23dd6e3-bd7f-4959-b5b3-e8e57291d8cc12013-02-13
0781-3152-95ML - Milliliter0781-31529e3fd9bd-a788-4179-9607-60e18db5dd0c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CISATRACURIUM BESYLATEACTIVE INGREDIENT80YS8O1MBSCISATRACURIUM BESYLATE INJECTION [SANDOZ INC]2
CISATRACURIUMACTIVE MOIETYQX62KLI41NCISATRACURIUM BESYLATE INJECTION [SANDOZ INC]2
BENZENESULFONIC ACIDINACTIVE INGREDIENT685928Z18ACISATRACURIUM BESYLATE INJECTION [SANDOZ INC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCISATRACURIUM BESYLATE INJECTION [SANDOZ INC]2
WATERINACTIVE INGREDIENT059QF0KO0RCISATRACURIUM BESYLATE INJECTION [SANDOZ INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3152CISATRACURIUM BESYLATE INJECTION [SANDOZ INC]6Current NDC, Legacy NDC, 2 package rows20250221_2ee0358e-2cce-40d3-9fcf-1b9088815c98.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cisatracurium besylateCISATRACURIUM BESYLATESandoz Inc2ee0358e-2cce-40d3-9fcf-1b9088815c982024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200159
application number: ANDA200159
ndc (product): 0781-3152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSN2ee0358e-2cce-40d3-9fcf-1b9088815c986
199211cisatracurium 2 MG/ML Injectable SolutionSCD2ee0358e-2cce-40d3-9fcf-1b9088815c986
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSY2ee0358e-2cce-40d3-9fcf-1b9088815c986

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3152-700078131527010 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
0781-3152-950078131529510 VIAL, MULTI-DOSE in 1 CARTON (0781-3152-95) / 10 mL in 1 VIAL, MULTI-DOSE (0781-3152-70) 2012-07-160000-00-00NoNoCurrent