Cisatracurium besylate

Product NDC: 70436-112
11-digit product format: 704360112
Labeler code: 70436
Product ID: 70436-112_20cd9789-700a-5fa0-e063-6394a90a5d0d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cisatracurium besylate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Slate Run Pharmaceuticals, LLC
Application: ANDA216539
Marketing category: ANDA
Marketing start: 2021-09-02
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
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
2026-08-18 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
2026-08-18 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…`

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
49185e78-d244-4426-90ef-ad109824eddb	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	Strength	SPL version
70436-112-82	Cisatracurium besylate	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION	5		2
70436-112-82	Cisatracurium besylate	10 in 1 CARTON	INJECTION	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70436-112	CISATRACURIUM BESYLATE INJECTION [SLATE RUN PHARMACEUTICALS, LLC]	2	Current NDC, 2 package rows	20240830_49185e78-d244-4426-90ef-ad109824eddb.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 · 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
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 ndc (product): 70436-112

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	49185e78-d244-4426-90ef-ad109824eddb	2
199212	cisatracurium besylate 200 MG in 20 ML Injection	PSN	49185e78-d244-4426-90ef-ad109824eddb	2
199212	20 ML cisatracurium 10 MG/ML Injection	SCD	49185e78-d244-4426-90ef-ad109824eddb	2
1730194	5 ML cisatracurium 2 MG/ML Injection	SCD	49185e78-d244-4426-90ef-ad109824eddb	2
1730194	cisatracurium (as cisatracurium besylate) 10 MG per 5 ML Injection	SY	49185e78-d244-4426-90ef-ad109824eddb	2
199212	cisatracurium (as cisatracurium besylate) 200 MG per 20 ML Injection	SY	49185e78-d244-4426-90ef-ad109824eddb	2
199212	cisatracurium 200 MG per 20 ML Injection	SY	49185e78-d244-4426-90ef-ad109824eddb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70436-112-82	70436011282	10 VIAL, SINGLE-DOSE in 1 CARTON (70436-112-82) / 5 mL in 1 VIAL, SINGLE-DOSE	2021-09-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cisatracurium besylate	Slate Run Pharmaceuticals, LLC \| Hainan Poly Pharm. Co., Ltd.	2024-08-29	HUMAN PRESCRIPTION DRUG LABEL	2