Cisatracurium Besylate

Product NDC: 0703-2033
11-digit product format: 007032033
Labeler code: 0703
Product ID: 0703-2033_03d8934d-8294-48ae-b46f-a84b0bf44407
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cisatracurium Besylate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Teva Parenteral Medicines, Inc.
Application: ANDA204960
Marketing category: ANDA
Marketing start: 2018-09-04
Marketing end: 0000-00-00
Substance: CISATRACURIUM BESYLATE
Active strength: 10 mg/5mL
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	0703-2033		D	Discontinued by firm		2026-10-15
excluded package	package	0703-2033	0703-2033-03	D	Discontinued by firm		2026-10-15

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0703-2033-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0703-2033-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0703-2033-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0703-2033-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0703-2033-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0703-2033-03	`cdf11ea48f46…`	`ba0047e9e063…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	2017-01-27
A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	2017-09-19
A204960-003	CISATRACURIUM BESYLATE	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	2017-08-30

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 · 96 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
2026-10-15 13:18:30	2026-09	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2017-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2017-09-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204960-003	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2017-08-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2017-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204960-003	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2017-08-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2017-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2017-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204960-003	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2017-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204960-003	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204960-003	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204960-003	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204960-003	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204960-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2017-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204960-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2017-01-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A204960-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204960-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204960-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204960-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204960-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204960-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204960-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204960-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204960-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204960-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204960-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204960-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204960-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204960-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204960-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204960-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204960-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204960-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204960-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204960-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204960-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204960-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204960-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204960-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204960-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204960-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204960-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204960-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204960-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204960-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204960-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204960-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204960-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204960-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204960-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204960-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204960-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204960-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204960-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A204960-002	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0703-2033-03	2021-08-12	C162847	48780-1	c7ccaba7-1cad-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use CISATRACURIUM BESYLATE INJECTION safely and effectively. See full prescribing information for CISATRACURIUM BESYLATE INJECTION. CISATRACURIUM BESYLATE injection, for intravenous use Initial U.S. Approval: 1995
0703-2033-03	2021-07-23	C162847	48780-1	c7ccaba7-1cad-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use CISATRACURIUM BESYLATE INJECTION safely and effectively. See full prescribing information for CISATRACURIUM BESYLATE INJECTION. CISATRACURIUM BESYLATE injection, for intravenous use Initial U.S. Approval: 1995

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0703-2033-03	ML - Milliliter	0703-2033	149fd5bf-f293-4cb8-b423-5d4ea7dde5d3	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0703-2033	CISATRACURIUM BESYLATE INJECTION [TEVA PARENTERAL MEDICINES, INC.]	25	Legacy NDC	20241228_c6e6823b-fa28-4da2-b3f4-9ad0f92782ce.zip

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
0703-2033-03	00703203303	10 CARTON in 1 BOX (0703-2033-03) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE	10 carton	2018-09-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cisatracurium Besylate	Teva Parenteral Medicines, Inc.	2022-10-31	HUMAN PRESCRIPTION DRUG LABEL	25