Evzio

Product NDC
60842-051
11-digit product format
608420051
Labeler code
60842
Product ID
60842-051_83e4f9d7-f667-49b6-8406-65381e98ea21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
kaleo, Inc.
Application
NDA209862
Marketing category
NDA
Marketing start
2016-10-19
Marketing end
2021-09-30
Substance
NALOXONE HYDROCHLORIDE
Active strength
2 mg/.4mL
Pharmacologic classes
Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c955d208-c333-9bd7-be34-d7e12986d44eProduct name620250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304Product name120250204
caa6391e-3db3-c912-335f-61b5fc00aa12Product name920240110
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
e951cdf3-f269-4d97-a7d5-c1c3d7283a7dProduct name320230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
f327b80c-8fa2-404b-838a-df3eec141cf2Product name120221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119Product name120220511
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9Product name120211026
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60842-051-01ML - Milliliter60842-0511b883dd0-837c-457a-9d56-b25dc52c924212017-03-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1855730naloxone HCl 2 MG in 0.4 ML Auto-InjectorPSN9be31bdf-e220-2978-e053-2a95a90a03c62
18557300.4 ML naloxone hydrochloride 5 MG/ML Auto-InjectorSCD9be31bdf-e220-2978-e053-2a95a90a03c62
1855730naloxone HCl 2 MG per 0.4 ML Auto-InjectorSY9be31bdf-e220-2978-e053-2a95a90a03c62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60842-051-01608420051012 DOSE PACK in 1 CARTON (60842-051-01) > .4 mL in 1 DOSE PACK2 dose pack2016-10-190000-00-00NoNoCurrent