CUBICIN RF

Product NDC
67919-012
11-digit product format
679190012
Labeler code
67919
Product ID
67919-012_12165af7-0ba8-4dd6-a13c-9ac832e7fe8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Merck Sharp & Dohme LLC
Application
NDA021572
Marketing category
NDA
Marketing start
2016-09-13
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
2023-12-31
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67919-012-01CUBICIN RF1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,122
67919-012-01CUBICIN RF10 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,1022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67919-012-02EA - Each67919-012a2ff6da3-4411-49f3-98a9-a2049a62f31712016-10-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404652CUBICIN 500 MG InjectionPSN0b1a8885-2198-4a0e-8105-0c76c1cba6c222
403920DAPTOmycin 500 MG InjectionPSN0b1a8885-2198-4a0e-8105-0c76c1cba6c222
404652daptomycin 500 MG Injection [Cubicin]SBD0b1a8885-2198-4a0e-8105-0c76c1cba6c222
403920daptomycin 500 MG InjectionSCD0b1a8885-2198-4a0e-8105-0c76c1cba6c222
404652Cubicin 500 MG InjectionSY0b1a8885-2198-4a0e-8105-0c76c1cba6c222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67919-012-01679190012011 VIAL, SINGLE-USE in 1 CARTON (67919-012-01) > 10 mL in 1 VIAL, SINGLE-USE2016-07-060000-00-00NoNoCurrent
67919-012-02679190012021 VIAL, SINGLE-USE in 1 CARTON (67919-012-02) > 10 mL in 1 VIAL, SINGLE-USE2016-09-130000-00-00NoNoCurrent