daptomycin

Product NDC
69097-850
11-digit product format
690970850
Labeler code
69097
Product ID
69097-850_219e8987-0f88-4149-80e3-77d97e555791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Cipla USA Inc.
Application
ANDA213425
Marketing category
ANDA
Marketing start
2021-03-26
Marketing end
0000-00-00
Substance
DAPTOMYCIN
Active strength
350 mg/7mL
Pharmacologic classes
Lipopeptide Antibacterial [EPC],Lipopeptides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45ca3ac7-6ee8-4e99-92a6-dc0b401e151aProduct name120250724
223d8260-7a4e-4ebd-9635-845422d6a8adProduct name920240909
ca803a62-3799-476f-bbc6-024f77cb0320Product name420240207
cad85d83-8fb9-49f8-a5a6-a399af412964Product name120230922
8e59a5ed-f224-4156-b534-1ae4d0b6dfd7Product name120230721
ea2c89ab-e8f8-425f-9693-c923fa1e1703Product name120220929

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-850-67EA - Each69097-85009c4d611-b6a4-42ba-a232-a6db41bf434312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-850DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CIPLA USA INC.]1Legacy NDC20210327_219e8987-0f88-4149-80e3-77d97e555791.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-850-67690970850671 VIAL in 1 CARTON (69097-850-67) > 7 mL in 1 VIAL1 vial2021-03-260000-00-00NoNoCurrent