NALOXONE HYDROCHLORIDE

Product NDC
51662-1529
11-digit product format
516621529
Labeler code
51662
Product ID
51662-1529_11ffcd59-50e0-e296-e063-6294a90a9fb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NALOXONE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA213209
Marketing category
ANDA
Marketing start
2021-07-15
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1529-1NALOXONE HYDROCHLORIDE2 mL in 1 SYRINGEINJECTION23
51662-1529-1NALOXONE HYDROCHLORIDE1 in 1 BOXINJECTION13
51662-1529-2NALOXONE HYDROCHLORIDE2 mL in 1 SYRINGEINJECTION23
51662-1529-2NALOXONE HYDROCHLORIDE1 in 1 POUCHINJECTION13
51662-1529-3NALOXONE HYDROCHLORIDE10 in 1 BOXINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1529NALOXONE HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 5 package rows20240224_c72a60fb-196d-3f02-e053-2995a90ad906.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSNc72a60fb-196d-3f02-e053-2995a90ad9063
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCDc72a60fb-196d-3f02-e053-2995a90ad9063
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSYc72a60fb-196d-3f02-e053-2995a90ad9063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1529-1516621529011 SYRINGE in 1 BOX (51662-1529-1) / 2 mL in 1 SYRINGE1 syringe2021-07-150000-00-00NoNoCurrent
51662-1529-2516621529022 mL in 1 SYRINGE2 mlHistorical
51662-1529-35166215290310 POUCH in 1 BOX (51662-1529-3) / 1 SYRINGE in 1 POUCH (51662-1529-2) / 2 mL in 1 SYRINGE10 pouch2022-05-110000-00-00NoNoCurrent