DAPTOMYCIN

Product NDC
71288-018
11-digit product format
712880018
Labeler code
71288
Product ID
71288-018_24a6aad9-6faf-4780-b535-9e3998c0b08f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DAPTOMYCIN
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA212513
Marketing category
ANDA
Marketing start
2019-06-26
Marketing end
2023-09-30
Substance
DAPTOMYCIN
Active strength
500 mg/10mL
Pharmacologic classes
Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-018-10EA - Each71288-018ca2e4191-b089-4df8-b6b5-ae30ea0c03f612020-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-018-10712880018101 VIAL, SINGLE-DOSE in 1 CARTON (71288-018-10) > 10 mL in 1 VIAL, SINGLE-DOSE2019-06-262023-09-30NoNoCurrent