Cisatracurium Besylate

Product NDC: 0409-5547
11-digit product format: 004095547
Labeler code: 0409
Product ID: 0409-5547_9d9615b2-bc43-4267-a654-ba97f8139e62
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CISATRACURIUM BESYLATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA203236
Marketing category: ANDA
Marketing start: 2021-06-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0409-5547		D	Discontinued by firm		2026-08-17
excluded package	package	0409-5547	0409-5547-10	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0409-5547		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-5547	0409-5547-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A203236-001	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2018-03-30
A203236-002	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2018-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203236-001	AP
A203236-002	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	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2018-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2018-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203236-001	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203236-002	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2018-03-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A203236-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203236-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203236-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203236-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203236-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203236-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203236-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203236-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203236-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203236-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203236-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203236-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203236-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203236-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203236-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203236-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203236-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203236-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203236-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203236-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203236-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203236-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203236-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203236-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203236-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203236-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203236-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203236-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203236-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203236-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203236-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203236-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203236-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203236-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203236-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203236-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203236-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203236-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203236-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203236-002	AP	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-5547-01	ML - Milliliter	0409-5547	0589f9ba-949e-42c9-b050-60171a19d12a	1	2021-07-15
0409-5547-10	ML - Milliliter	0409-5547	4896a494-90f0-41c7-9c83-0b5ff6496461	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-5547	CISATRACURIUM BESYLATE INJECTION, SOLUTION [HOSPIRA, INC.]	6	Legacy NDC	20240411_7073cb55-f766-4092-a10b-c2cb2863a044.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	Hospira, Inc.	67908e20-044d-454d-9c51-bf106e817bd0	2026-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203236 application number: ANDA203236

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-5547-10	00409554710	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-5547-10) > 5 mL in 1 VIAL, SINGLE-DOSE (0409-5547-01)	2021-06-01	0000-00-00	No	No	Current