FDA.reportPublic FDA data

Naloxone Hydrochloride

Product NDC
55150-345
11-digit product format
551500345
Labeler code
55150
Product ID
55150-345_6b48182a-4a21-4157-8efb-591ee87fb7d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Eugia US LLC
Application
ANDA213279
Marketing category
ANDA
Marketing start
2021-01-14
Substance
NALOXONE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naloxone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALOXONE HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF850569PQR
Rxcui1191250

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
55150-345-012024-01-30C16284748780-11030e365-2a43-111a-e063-dadaa90a10e2Naloxone Hydrochloride Injection, USP Opioid Antagonist Rx only
55150-345-102024-01-30C16284748780-11030e365-2a43-111a-e063-dadaa90a10e2Naloxone Hydrochloride Injection, USP Opioid Antagonist Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-345-01Naloxone Hydrochloride1 in 1 BOXINJECTION, SOLUTION16
55150-345-01Naloxone Hydrochloride2 mL in 1 SYRINGEINJECTION, SOLUTION26
55150-345-10Naloxone Hydrochloride2 mL in 1 SYRINGEINJECTION, SOLUTION26
55150-345-10Naloxone Hydrochloride10 in 1 BOXINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-345-01ML - Milliliter55150-3451486520f-201d-46cd-9924-87836aea207f12021-03-02
55150-345-10ML - Milliliter55150-345a3ff78bb-a1a4-4ec0-9937-88241a8c98b912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-345NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]6Current NDC, Legacy NDC, 4 package rows20250519_8bcf426a-b4fc-4f24-9ad0-fb26168a0b56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSN8bcf426a-b4fc-4f24-9ad0-fb26168a0b566
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCD8bcf426a-b4fc-4f24-9ad0-fb26168a0b566
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSY8bcf426a-b4fc-4f24-9ad0-fb26168a0b566
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSNf9c5efca-443a-41a0-e053-6294a90a87743
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCDf9c5efca-443a-41a0-e053-6294a90a87743
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSYf9c5efca-443a-41a0-e053-6294a90a87743
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSNe65e03c1-9a66-b30b-e053-2995a90aeb732
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCDe65e03c1-9a66-b30b-e053-2995a90aeb732
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSYe65e03c1-9a66-b30b-e053-2995a90aeb732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-345-01551500345011 SYRINGE in 1 BOX (55150-345-01) / 2 mL in 1 SYRINGE1 syringe2021-01-140000-00-00NoNoCurrent
55150-345-105515003451010 SYRINGE in 1 BOX (55150-345-10) / 2 mL in 1 SYRINGE10 syringe2021-01-140000-00-00NoNoCurrent