FDA.reportPublic FDA data

Vecuronium Bromide

Product NDC
0143-9234
11-digit product format
001439234
Labeler code
0143
Product ID
0143-9234_447053f5-3015-4770-9e16-a5c82513249d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vecuronium Bromide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA203725
Marketing category
ANDA
Marketing start
2019-08-01
Substance
VECURONIUM BROMIDE
Active strength
10 mg/1
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vecuronium Bromide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VECURONIUM BROMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7E4PHP5N1D
Rxcui859437

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec3684c3-bbd0-48b6-aac1-2a439cf50145Product name220200114

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9234-01Vecuronium Bromide1 in 1 VIALINJECTION, POWDER, FOR SOLUTION14
0143-9234-10Vecuronium Bromide10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9234-01EA - Each0143-9234c8e0a39b-1b89-4630-9aea-1ccba662008c12020-04-20
0143-9234-10EA - Each0143-9234044dff0d-27c4-4d0e-be98-71173ce511de12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9234VECURONIUM BROMIDE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 2 package rows20240719_dceeec01-2910-4489-8d70-9c0c711d17ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859437vecuronium bromide 1 MG/ML Injectable SolutionPSNdceeec01-2910-4489-8d70-9c0c711d17ab4
859437vecuronium bromide 1 MG/ML Injectable SolutionSCDdceeec01-2910-4489-8d70-9c0c711d17ab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9234-01001439234011 in 1 VIALHistorical
0143-9234-100014392341010 VIAL in 1 CARTON (0143-9234-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9234-01) 10 vial2019-08-010000-00-00NoNoCurrent