Cisatracurium Besylate

Product NDC: 24584-1111
Requested package NDC: 24584-1111-1
11-digit product format: 245841111
Labeler code: 24584
Product ID: 24584-1111_6c052e39-545c-4686-aa3e-d17ab471a50e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cisatracurium Besylate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Piramal Healthcare UK Limited
Application: ANDA212432
Marketing category: ANDA
Marketing start: 2019-04-02
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	24584-1111	24584-1111-1	D	Discontinued by firm		2026-08-17

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
A212432-001	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2022-03-11
A212432-002	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2022-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212432-001	AP
A212432-002	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 2 · 62 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	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2022-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2022-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2022-03-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2022-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2022-03-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2022-03-11	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212432-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212432-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2022-03-11	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212432-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212432-002	AP	1	`caaa826d4ba7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212432-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212432-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212432-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212432-002	AP	1	`5d02ea3f76ae…`
2022-09-29 23:25 UTC	2022-09	A212432-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A212432-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212432-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212432-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212432-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212432-002	AP	1	`a50c72e98297…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24584-1111	CISATRACURIUM BESYLATE INJECTION [PIRAMAL HEALTHCARE UK LIMITED]	4	Legacy NDC	20220326_2a68c2bc-3875-4782-820c-7dcad545ba9b.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	Camber Pharmaceuticals Inc.	d8b5eb77-b393-4cd7-86c5-d2a9d131f96d	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212432 application number: ANDA212432

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24584-1111-1	24584111101	5 mL in 1 VIAL, SINGLE-DOSE (24584-1111-1)	5 ml	2019-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cisatracurium Besylate	Piramal Healthcare UK Limited \| Sharp Corporation \| Piramal Pharma Solutions Inc.	2022-01-17	Human Prescription Drug Label	4