FDA.reportPublic FDA data

Vecuronium Bromide

Product NDC
81565-206
11-digit product format
815650206
Labeler code
81565
Product ID
81565-206_afbb4404-c290-4976-9faa-79cb56a64a1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vecuronium Bromide
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Phlow Corp.
Application
ANDA203725
Marketing category
ANDA
Marketing start
2019-08-01
Marketing end
2027-01-31
Substance
VECURONIUM BROMIDE
Active strength
10 mg/1
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vecuronium Bromide

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
81565-206-01Vecuronium Bromide1 in 1 VIALINJECTION, POWDER, FOR SOLUTION16
81565-206-02Vecuronium Bromide10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81565-206-01EA - Each81565-2069027e28a-a540-46c9-b582-7cc248bb716812023-06-06
81565-206-02EA - Each81565-20624924f82-706b-458f-8cf6-012a43f54be912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81565-206VECURONIUM BROMIDE INJECTION, POWDER, FOR SOLUTION [PHLOW CORP.]3Current NDC, Legacy NDC, 2 package rows20240308_b012b1b1-9e59-4525-8f4d-dae98344d15f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859437vecuronium bromide 1 MG/ML Injectable SolutionPSNb012b1b1-9e59-4525-8f4d-dae98344d15f6
859437vecuronium bromide 1 MG/ML Injectable SolutionSCDb012b1b1-9e59-4525-8f4d-dae98344d15f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81565-206-01815650206011 in 1 VIALHistorical
81565-206-028156502060210 VIAL in 1 CARTON (81565-206-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (81565-206-01) 10 vial2023-01-112027-01-31NoNoCurrent