Cisatracurium Besylate

Product NDC: 83634-655
Requested package NDC: 83634-655-20
11-digit product format: 836340655
Labeler code: 83634
Product ID: 83634-655_53f69aa3-898e-476d-b18c-573487371a10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cisatracurium besylate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Avenacy, LLC
Application: ANDA216539
Marketing category: ANDA
Marketing start: 2026-08-15
Substance: CISATRACURIUM BESYLATE
Active strength: 10 mg/mL
Pharmacologic classes: Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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
A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2024-08-27
A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		2024-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216539-001	AP
A216539-002	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.

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	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2024-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2024-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2024-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2024-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2024-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION		2024-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		2024-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216539-001	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216539-002	CISATRACURIUM BESYLATE PRESERVATIVE FREE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	2024-08-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A216539-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216539-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A216539-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216539-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216539-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216539-002	AP	1	`caaa826d4ba7…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216539-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216539-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216539-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216539-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216539-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216539-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216539-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216539-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216539-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216539-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216539-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216539-002	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216539-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216539-002	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Cisatracurium Besylate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CISATRACURIUM BESYLATE	10 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199212	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
1c6a8b98-deac-4e25-b4a0-5d0af5090281	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cisatracurium Besylate	CISATRACURIUM BESYLATE	Avenacy, LLC	1c6a8b98-deac-4e25-b4a0-5d0af5090281	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216539 application number: ANDA216539 ndc (package): 83634-655-20 ndc (product): 83634-655 ndc11 (package): 83634065520
Cisatracurium besylate	CISATRACURIUM BESYLATE	Slate Run Pharmaceuticals, LLC	49185e78-d244-4426-90ef-ad109824eddb	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216539 application number: ANDA216539

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	Sample	Exclude flag	Status
83634-655-20	83634065520	10 VIAL, SINGLE-DOSE in 1 CARTON (83634-655-20) / 20 mL in 1 VIAL, SINGLE-DOSE (83634-655-41)	2026-08-15	No	No	Current