Oxaliplatin

Product NDC
45963-611
11-digit product format
459630611
Labeler code
45963
Product ID
45963-611_f32f6b99-5065-44ad-8714-869821c5640a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaliplatin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Actavis Pharma, Inc.
Application
ANDA078803
Marketing category
ANDA
Marketing start
2015-01-05
Marketing end
0000-00-00
Substance
OXALIPLATIN
Active strength
5 mg/mL
Pharmacologic classes
Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-611-53EA - Each45963-611ffb62f57-c756-496f-8b2c-456ff89d10d312015-02-02
45963-611-59EA - Each45963-6118ffd903d-93ae-4e16-bba9-dee9e70cee8012015-02-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45963-611-53459630611531 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-53) > 10 mL in 1 VIAL, SINGLE-DOSE2015-01-050000-00-00NoNoCurrent
45963-611-59459630611591 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-59) > 20 mL in 1 VIAL, SINGLE-DOSE2015-01-050000-00-00NoNoCurrent