FDA.reportPublic FDA data

cisatracurium besylate

Product NDC
70710-1534
11-digit product format
707101534
Labeler code
70710
Product ID
70710-1534_6441f3e5-0868-4b57-badf-d6a8ea7e8584
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cisatracurium besylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA212171
Marketing category
ANDA
Marketing start
2020-02-12
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#

Finished product
Yes
Brand name base
cisatracurium besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CISATRACURIUM BESYLATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80YS8O1MBS
Rxcui199212, 1730194

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bde27158-d1b9-e941-8af6-709c63f1bc54Product name920200925

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1534-1cisatracurium besylate20 mL in 1 VIALINJECTION205
70710-1534-6cisatracurium besylate10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1534-1ML - Milliliter70710-1534c1604175-ce74-4315-b4a6-9bcc8680f1a112021-02-05
70710-1534-6ML - Milliliter70710-153484458205-5fff-4dbd-a3dc-90e0a94fdbde12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1534CISATRACURIUM BESYLATE INJECTION [ZYDUS PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240821_f9e1a84b-d19e-46c5-b40f-944ac1543dac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1730194cisatracurium besylate 10 MG in 5 ML InjectionPSNf9e1a84b-d19e-46c5-b40f-944ac1543dac5
199212cisatracurium besylate 200 MG in 20 ML InjectionPSNf9e1a84b-d19e-46c5-b40f-944ac1543dac5
19921220 ML cisatracurium 10 MG/ML InjectionSCDf9e1a84b-d19e-46c5-b40f-944ac1543dac5
17301945 ML cisatracurium 2 MG/ML InjectionSCDf9e1a84b-d19e-46c5-b40f-944ac1543dac5
1730194cisatracurium (as cisatracurium besylate) 10 MG per 5 ML InjectionSYf9e1a84b-d19e-46c5-b40f-944ac1543dac5
199212cisatracurium (as cisatracurium besylate) 200 MG per 20 ML InjectionSYf9e1a84b-d19e-46c5-b40f-944ac1543dac5
199212cisatracurium 200 MG per 20 ML InjectionSYf9e1a84b-d19e-46c5-b40f-944ac1543dac5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1534-17071015340120 mL in 1 VIAL20 mlHistorical
70710-1534-67071015340610 VIAL in 1 CARTON (70710-1534-6) / 20 mL in 1 VIAL (70710-1534-1) 10 vial2020-02-120000-00-00NoNoCurrent