EVZIO(R) NALOXONE HCl

Product NDC
51662-1495
11-digit product format
516621495
Labeler code
51662
Product ID
51662-1495_9f4536f0-d9de-3b36-e053-2a95a90ab8f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EVZIO(R) NALOXONE HCl
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA209862
Marketing category
NDA
Marketing start
2020-01-11
Marketing end
0000-00-00
Substance
NALOXONE HYDROCHLORIDE
Active strength
2 mg/.4mL
Pharmacologic classes
Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1495-12025-01-30C16284748780-12cef2736-5f3b-d83d-e063-dadaa90ab31fEVZIO(R) NALOXONE HCl INJECTION, USP 2mg AUTO-INJECTOR 2 PACK

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1495-1EVZIO(R) NALOXONE HCl0.4 mL in 1 DOSE PACKINJECTION, SOLUTION0.42
51662-1495-1EVZIO(R) NALOXONE HCl2 in 1 CARTONINJECTION, SOLUTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1495EVZIO(R) NALOXONE HCL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Legacy NDC, 2 package rows20200224_9be31bdf-e220-2978-e053-2a95a90a03c6.zip

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
51662-1495-1516621495012 DOSE PACK in 1 CARTON (51662-1495-1) > .4 mL in 1 DOSE PACK2 dose pack2020-01-110000-00-00NoNoCurrent