Cisatracurium Besalayte Injection, USP

Manufacturer
Zydus Lifesciences Limited
Effective date
2022-10-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:51:23

Label at a glance#

Productcisatracurium besylate
Active ingredientCISATRACURIUM BESYLATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label (20 mg/10 mL)

NDC 72758-0011-1

Cisatracurium Besylate Injection, USP

20 mg/10 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

0.9% benzyl alcohol (added as a preservative)

10 mL Multiple-Dose Vial

Rx only

vial label
vial label

Carton Label (20 mg/10 mL)

NDC 72758-0011-1

Cisatracurium Besylate Injection, USP

20 mg/10 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

0.9% benzyl alcohol (added as a preservative)

10 mL Multiple-Dose Vial

Rx only

carton for 1 vial
carton for 1 vial

Carton Label (20 mg/10 mL)

NDC 72758-0011-6

Cisatracurium Besylate Injection, USP

20 mg/10 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

0.9% benzyl alcohol (added as a preservative)

10 x 10 mL Multiple-Dose Vial

Rx only

carton of 10 vials
carton of 10 vials

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72785-0011CISATRACURIUM BESYLATE INJECTION [ZYDUS LIFESCIENCES LIMITED]2Legacy NDC20221019_ac58faa8-7291-4128-9646-c00be0ce3f81.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72785-001172785-0011-1, 72785-0011-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A213527-001CISATRACURIUM BESYLATECISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-09-01

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
2026-10-15 13:18:302026-09A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-09-01c2088c7a36db…
2026-09-14 22:38:342026-08A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-09-0184e616aacf4f…
2026-08-18 06:07:402026-07A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-09-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-09-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-09-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-314b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-08-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-08-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTIONAP2020-08-31c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-08-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213527-001CISATRACURIUM BESYLATEEQ 2MG BASE/MLINJECTABLE / INJECTION2020-09-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-03-12 10:30 UTC2021-03A213527-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213527-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213527-001AP1c0c555d07b60…

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
2f5a1479-0707-4b89-b2e0-b61d55ae6503ac58faa8-7291-4128-9646-c00be0ce3f812025-05-31Exact identifier
spl set id: ac58faa8-7291-4128-9646-c00be0ce3f81

Reported adverse events (FAERS/openFDA)#

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