CISATRACURIUM BESYLATE INJECTION

Manufacturer: Zydus Lifesciences Limited
Effective date: 2022-11-05
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:44:50

Label at a glance#

Productcisatracurium besylate

Active ingredientCISATRACURIUM BESYLATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Container Label (10 mg/5 mL)

NDC 72785-0008-1

Cisatracurium Besylate Injection, USP

10 mg/5 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

Preservative free

5 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

Principal Display Panel – Container Label (200 mg/20 mL)

NDC 72785-0009-1

Cisatracurium Besylate Injection, USP

200 mg/20 mL*

(10 mg/mL)

WARNING: Paralyzing Agent

For ICU use only.

For Intravenous Injection

Preservative free

20 mL Single-Dose Vial

Rx only

Zydus Pharmaceuticals

Principal Display Panel – Carton Label (10 mg/5 mL)

NDC 72785-0008-6

Cisatracurium Besylate Injection, USP

10 mg/5 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

Preservative free

10 x 5 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals

Principal Display Panel – Carton Label (200 mg/20 mL)

NDC 72785-0009-6

Cisatracurium Besylate Injection, USP

200 mg/20 mL*

(10 mg/mL)

WARNING: Paralyzing Agent

For ICU use only.

For Intravenous Injection

Preservative free

10 x 20 mL Single-Dose Vials

Rx only

Zydus Pharmaceuticals

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1730194	cisatracurium besylate 10 MG in 5 ML Injection	PSN	3
199212	cisatracurium besylate 200 MG in 20 ML Injection	PSN	3
199212	20 ML cisatracurium 10 MG/ML Injection	SCD	3
1730194	5 ML cisatracurium 2 MG/ML Injection	SCD	3
1730194	cisatracurium (as cisatracurium besylate) 10 MG per 5 ML Injection	SY	3
199212	cisatracurium (as cisatracurium besylate) 200 MG per 20 ML Injection	SY	3
199212	cisatracurium 200 MG per 20 ML Injection	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CISATRACURIUM Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bde27158-d1b9-e941-8af6-709c63f1bc54	Product name	9	20200925

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72785-0008-1	cisatracurium besylate	5 mL in 1 VIAL	INJECTION	5	3
72785-0008-6	cisatracurium besylate	10 in 1 CARTON	INJECTION	10	3
72785-0009-1	cisatracurium besylate	20 mL in 1 VIAL	INJECTION	20	3
72785-0009-6	cisatracurium besylate	10 in 1 CARTON	INJECTION	10	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72785-0008	CISATRACURIUM BESYLATE INJECTION [ZYDUS LIFESCIENCES LIMITED]	3	Current NDC, Legacy NDC, 2 package rows	20221108_e145a40e-b046-4064-b35e-0da40ff3703e.zip
72785-0009	CISATRACURIUM BESYLATE INJECTION [ZYDUS LIFESCIENCES LIMITED]	3	Current NDC, Legacy NDC, 2 package rows	20221108_e145a40e-b046-4064-b35e-0da40ff3703e.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

cisatracurium besylate
CISATRACURIUM
BENZENESULFONIC ACID
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72785-0008	72785-0008-1, 72785-0008-6
72785-0009	72785-0009-1, 72785-0009-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CISATRACURIUM BESYLATE	80YS8O1MBS	ACTIM
BENZENESULFONIC ACID	685928Z18A	IACT
WATER	059QF0KO0R	IACT
CISATRACURIUM BESYLATE	80YS8O1MBS	ACTIM
BENZENESULFONIC ACID	685928Z18A	IACT
WATER	059QF0KO0R	IACT

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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212171-001	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2019-11-04
A212171-002	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2019-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212171-001	AP
A212171-002	AP

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212171-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212171-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2019-11-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212171-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212171-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212171-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212171-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212171-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212171-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212171-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212171-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212171-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212171-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212171-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212171-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212171-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212171-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212171-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212171-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212171-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212171-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212171-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212171-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212171-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212171-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212171-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212171-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212171-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212171-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212171-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212171-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212171-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212171-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212171-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212171-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212171-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212171-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212171-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212171-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212171-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212171-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212171-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212171-002	AP	1	`74a2ff9319b5…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cisatracurium besylate	CISATRACURIUM BESYLATE	Zydus Lifesciences Limited	e145a40e-b046-4064-b35e-0da40ff3703e	2022-11-05		Exact identifier ndc (package): 72785-0008-6 ndc (package): 72785-0009-6 ndc (package): 72785-0008-1 ndc (package): 72785-0009-1 ndc (product): 72785-0009 ndc (product): 72785-0008 ndc11 (package): 72785000806 ndc11 (package): 72785000906 ndc11 (package): 72785000801 ndc11 (package): 72785000901 spl id: 1b257332-a1a5-406e-86e4-283580657dc6 spl set id: e145a40e-b046-4064-b35e-0da40ff3703e

Reported adverse events (FAERS/openFDA)#

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