Carboplatin

Product NDC
71288-100
11-digit product format
712880100
Labeler code
71288
Product ID
71288-100_d5b09a1b-a45b-44d4-abde-26faf80dd09b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carboplatin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA077096
Marketing category
ANDA
Marketing start
2017-06-19
Marketing end
0000-00-00
Substance
CARBOPLATIN
Active strength
10 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-100-05ML - Milliliter71288-100988bec11-f386-4634-84d5-9ea7b73f5c9612017-10-13
71288-100-15ML - Milliliter71288-1002d3ec57e-e46e-445b-b8cd-ea526701e3ac12017-10-13
71288-100-45ML - Milliliter71288-1004781f76c-524b-43c7-b4ff-d84449eae56b12017-10-13
71288-100-51ML - Milliliter71288-10018362a8e-daf0-4cb0-acb1-63b9f9eeb3f812017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-100CARBOPLATIN INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]3Legacy NDC20221203_81757808-f609-40d1-a4c1-08b32234719f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-100-05712880100051 VIAL in 1 CARTON (71288-100-05) > 5 mL in 1 VIAL1 vial2017-06-190000-00-00NoNoCurrent
71288-100-15712880100151 VIAL in 1 CARTON (71288-100-15) > 15 mL in 1 VIAL1 vial2017-06-190000-00-00NoNoCurrent
71288-100-45712880100451 VIAL in 1 CARTON (71288-100-45) > 45 mL in 1 VIAL1 vial2017-06-190000-00-00NoNoCurrent
71288-100-51712880100511 VIAL in 1 CARTON (71288-100-51) > 60 mL in 1 VIAL1 vial2017-06-190000-00-00NoNoCurrent