Daptomycin

Product NDC
31722-102
11-digit product format
317220102
Labeler code
31722
Product ID
31722-102_774368a9-067c-4071-a397-2153d1a90242
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Camber Pharmaceuticals Inc.
Application
ANDA212513
Marketing category
ANDA
Marketing start
2021-01-04
Marketing end
0000-00-00
Substance
DAPTOMYCIN
Active strength
500 mg/10mL
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
31722-102-10EA - Each31722-102e7c20a68-f35a-4bcb-a21f-26a8e0d5f79d12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-102DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CAMBER PHARMACEUTICALS INC.]2Legacy NDC20210109_e9cc0c1d-bfab-48e6-9170-8266ef1e6c25.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-102-10317220102101 VIAL, SINGLE-DOSE in 1 CARTON (31722-102-10) > 10 mL in 1 VIAL, SINGLE-DOSE2021-01-040000-00-00NoNoCurrent