Cisatracurium Besylate

Product NDC
55150-286
11-digit product format
551500286
Labeler code
55150
Product ID
55150-286_d40d8c7d-32a9-4518-9043-766790c1037c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cisatracurium Besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA209144
Marketing category
ANDA
Marketing start
2020-05-08
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
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
A209144-001CISATRACURIUM BESYLATECISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-05-08

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
2026-08-18 06:07:402026-07A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-05-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-05-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209144-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-05-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209144-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209144-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209144-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209144-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209144-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209144-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209144-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209144-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209144-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209144-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209144-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209144-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209144-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209144-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209144-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209144-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209144-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A209144-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209144-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209144-001AP1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209144-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209144-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209144-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209144-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209144-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209144-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209144-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209144-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209144-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209144-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209144-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209144-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209144-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Cisatracurium Besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CISATRACURIUM BESYLATE20 mg/10mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199211Internal RxNorm lookup
1730194Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cb05c7e-6228-4e2d-a270-7659e3db3fa7Available 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
55150-286-01Cisatracurium Besylate10 mL in 1 VIAL, MULTI-DOSEINJECTION106
55150-286-10Cisatracurium Besylate10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-286-01ML - Milliliter55150-2867ef708ba-94a0-4ecd-92e7-fc47caf76f5512020-08-06
55150-286-10ML - Milliliter55150-2865209afc1-cd62-4065-8ab6-2542bb22a88312020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-286CISATRACURIUM BESYLATE INJECTION [EUGIA US LLC]5Current NDC, Legacy NDC, 2 package rows20240515_2cb05c7e-6228-4e2d-a270-7659e3db3fa7.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 BESYLATEEugia US LLC2cb05c7e-6228-4e2d-a270-7659e3db3fa72025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209144
application number: ANDA209144
ndc (product): 55150-286

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199211cisatracurium 2 MG/ML Injectable SolutionPSN2cb05c7e-6228-4e2d-a270-7659e3db3fa76
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSN2cb05c7e-6228-4e2d-a270-7659e3db3fa76
17301945 ML cisatracurium 2 MG/ML InjectionSCD2cb05c7e-6228-4e2d-a270-7659e3db3fa76
199211cisatracurium 2 MG/ML Injectable SolutionSCD2cb05c7e-6228-4e2d-a270-7659e3db3fa76
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSY2cb05c7e-6228-4e2d-a270-7659e3db3fa76
199211cisatracurium (as cisatracurium besylate) 2 MG/ML Injectable SolutionSY2cb05c7e-6228-4e2d-a270-7659e3db3fa76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-286-015515002860110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
55150-286-105515002861010 VIAL, MULTI-DOSE in 1 CARTON (55150-286-10) / 10 mL in 1 VIAL, MULTI-DOSE (55150-286-01) 2020-05-080000-00-00NoNoCurrent