cisatracurium besylate

Product NDC: 0781-3153
11-digit product format: 007813153
Labeler code: 0781
Product ID: 0781-3153_e26cdb06-a79d-44f0-a4c2-a0cc4e35ca87
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cisatracurium besylate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Sandoz Inc
Application: ANDA200154
Marketing category: ANDA
Marketing start: 2012-07-16
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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
CISATRACURIUM BESYLATE	10 mg/mL

Field, Values table
Field	Values
Unii	80YS8O1MBS
Rxcui	199212, 1730194

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bde27158-d1b9-e941-8af6-709c63f1bc54	Product name	9	20200925

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0781-3153-80	cisatracurium besylate	20 mL in 1 VIAL	INJECTION	20	12
0781-3153-80	cisatracurium besylate	1 in 1 BOX	INJECTION	1	12
0781-3153-95	cisatracurium besylate	10 in 1 CARTON	INJECTION	10	12

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3153-80	ML - Milliliter	0781-3153	6ae90928-8ef9-4ef5-a00a-1e9b0085aad8	1	2014-10-03
0781-3153-95	ML - Milliliter	0781-3153	ab3fd5ed-ae2e-49fb-9698-ccd9df17d28c	1	2013-02-13

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CISATRACURIUM BESYLATE	ACTIVE INGREDIENT	80YS8O1MBS	CISATRACURIUM BESYLATE INJECTION [SANDOZ INC]	5
CISATRACURIUM	ACTIVE MOIETY	QX62KLI41N	CISATRACURIUM BESYLATE INJECTION [SANDOZ INC]	5
BENZENESULFONIC ACID	INACTIVE INGREDIENT	685928Z18A	CISATRACURIUM BESYLATE INJECTION [SANDOZ INC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	CISATRACURIUM BESYLATE INJECTION [SANDOZ INC]	5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-3153	CISATRACURIUM BESYLATE INJECTION [SANDOZ INC]	12	Current NDC, Legacy NDC, 3 package rows	20250321_291a55dd-ab45-4660-b513-4ecb729eb051.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1730194	cisatracurium besylate 10 MG in 5 ML Injection	PSN	291a55dd-ab45-4660-b513-4ecb729eb051	12
199212	cisatracurium besylate 200 MG in 20 ML Injection	PSN	291a55dd-ab45-4660-b513-4ecb729eb051	12
199212	20 ML cisatracurium 10 MG/ML Injection	SCD	291a55dd-ab45-4660-b513-4ecb729eb051	12
1730194	5 ML cisatracurium 2 MG/ML Injection	SCD	291a55dd-ab45-4660-b513-4ecb729eb051	12
1730194	cisatracurium (as cisatracurium besylate) 10 MG per 5 ML Injection	SY	291a55dd-ab45-4660-b513-4ecb729eb051	12
199212	cisatracurium (as cisatracurium besylate) 200 MG per 20 ML Injection	SY	291a55dd-ab45-4660-b513-4ecb729eb051	12
199212	cisatracurium 200 MG per 20 ML Injection	SY	291a55dd-ab45-4660-b513-4ecb729eb051	12

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-3153-80	00781315380	20 mL in 1 VIAL	20 ml					Historical
0781-3153-95	00781315395	10 BOX in 1 CARTON (0781-3153-95) / 1 VIAL in 1 BOX (0781-3153-80) / 20 mL in 1 VIAL	10 box	2012-07-16	0000-00-00	No	No	Current