Naloxone Hydrochloride

Product NDC
70518-2725
11-digit product format
705182725
Labeler code
70518
Product ID
70518-2725_4a7f0729-7531-bba3-e063-6294a90a001b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
INJECTION
Route
PARENTERAL
Labeler
REMEDYREPACK INC.
Application
ANDA072076
Marketing category
ANDA
Marketing start
2020-05-05
Substance
NALOXONE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naloxone Hydrochloride
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2725-0Naloxone Hydrochloride10 in 1 BOXINJECTION108
70518-2725-1Naloxone Hydrochloride2 mL in 1 SYRINGEINJECTION28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2725NALOXONE HYDROCHLORIDE INJECTION [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 2 package rows20250402_68df290c-d776-4cfc-9565-332eb56c4723.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSN68df290c-d776-4cfc-9565-332eb56c47238
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCD68df290c-d776-4cfc-9565-332eb56c47238
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSY68df290c-d776-4cfc-9565-332eb56c47238

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2725-07051827250010 SYRINGE in 1 BOX (70518-2725-0) / 2 mL in 1 SYRINGE (70518-2725-1) 10 syringe2020-05-050000-00-00NoNoCurrent
70518-2725-1705182725012 mL in 1 SYRINGE2 mlHistorical