cisatracurium besylate

Product NDC: 0781-3150
11-digit product format: 007813150
Labeler code: 0781
Product ID: 0781-3150_e26cdb06-a79d-44f0-a4c2-a0cc4e35ca87
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cisatracurium besylate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Sandoz Inc
Application: ANDA200154
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2012-02-03
A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2012-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200154-001	AP
A200154-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200154-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200154-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2012-02-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A200154-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200154-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200154-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200154-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200154-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200154-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200154-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200154-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200154-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200154-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200154-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200154-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200154-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200154-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200154-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200154-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200154-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200154-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200154-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200154-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200154-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200154-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200154-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200154-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200154-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200154-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200154-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200154-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200154-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200154-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200154-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200154-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200154-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200154-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200154-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200154-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200154-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200154-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200154-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200154-002	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CISATRACURIUM BESYLATE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
80YS8O1MBS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199212	Internal RxNorm lookup
1730194	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
291a55dd-ab45-4660-b513-4ecb729eb051	Available on FDA.report

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
0781-3150-75	cisatracurium besylate	5 mL in 1 VIAL	INJECTION	5	12
0781-3150-75	cisatracurium besylate	1 in 1 BOX	INJECTION	1	12
0781-3150-95	cisatracurium besylate	10 in 1 CARTON	INJECTION	10	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3150-75	ML - Milliliter	0781-3150	a3faf700-fae8-43ed-b987-0685c68059bf	1	2014-10-03
0781-3150-95	ML - Milliliter	0781-3150	28c5c964-df7a-4538-a8c7-31784224242f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CISATRACURIUM BESYLATE	ACTIVE INGREDIENT	80YS8O1MBS	CISATRACURIUM BESYLATE INJECTION [SANDOZ INC]	5
CISATRACURIUM	ACTIVE MOIETY	QX62KLI41N	CISATRACURIUM BESYLATE INJECTION [SANDOZ INC]	5
BENZENESULFONIC ACID	INACTIVE INGREDIENT	685928Z18A	CISATRACURIUM BESYLATE INJECTION [SANDOZ INC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	CISATRACURIUM BESYLATE INJECTION [SANDOZ INC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-3150	CISATRACURIUM BESYLATE INJECTION [SANDOZ INC]	12	Current NDC, Legacy NDC, 3 package rows	20250321_291a55dd-ab45-4660-b513-4ecb729eb051.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cisatracurium besylate	CISATRACURIUM BESYLATE	Sandoz Inc	291a55dd-ab45-4660-b513-4ecb729eb051	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200154 application number: ANDA200154 ndc (product): 0781-3150

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
80YS8O1MBS	CISATRACURIUM BESYLATE	96946-42-8	CISATRACURIUM BESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1730194	cisatracurium besylate 10 MG in 5 ML Injection	PSN	291a55dd-ab45-4660-b513-4ecb729eb051	12
199212	cisatracurium besylate 200 MG in 20 ML Injection	PSN	291a55dd-ab45-4660-b513-4ecb729eb051	12
199212	20 ML cisatracurium 10 MG/ML Injection	SCD	291a55dd-ab45-4660-b513-4ecb729eb051	12
1730194	5 ML cisatracurium 2 MG/ML Injection	SCD	291a55dd-ab45-4660-b513-4ecb729eb051	12
1730194	cisatracurium (as cisatracurium besylate) 10 MG per 5 ML Injection	SY	291a55dd-ab45-4660-b513-4ecb729eb051	12
199212	cisatracurium (as cisatracurium besylate) 200 MG per 20 ML Injection	SY	291a55dd-ab45-4660-b513-4ecb729eb051	12
199212	cisatracurium 200 MG per 20 ML Injection	SY	291a55dd-ab45-4660-b513-4ecb729eb051	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-3150-75	00781315075	5 mL in 1 VIAL	5 ml					Historical
0781-3150-95	00781315095	10 BOX in 1 CARTON (0781-3150-95) / 1 VIAL in 1 BOX (0781-3150-75) / 5 mL in 1 VIAL	10 box	2012-07-16	0000-00-00	No	No	Current