FDA.reportPublic FDA data

Naloxone Hydrochloride

Product NDC
76329-1469
11-digit product format
763291469
Labeler code
76329
Product ID
76329-1469_2db33194-380a-4dd5-ba87-abdad14209bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
INJECTION
Route
PARENTERAL
Labeler
International Medication Systems, Limited
Application
ANDA072076
Marketing category
ANDA
Marketing start
1988-04-01
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
76329-1469-1Naloxone Hydrochloride2 mL in 1 SYRINGEINJECTION27
76329-1469-1Naloxone Hydrochloride10 in 1 BOXINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76329-1469-1ML - Milliliter76329-1469ce0501de-2c9e-4e9d-9c53-c09f1e91821212015-06-09
76329-1469-5ML - Milliliter76329-1469f568fbe3-a663-47fb-8697-ddc2156dc18a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Naloxone HydrochlorideACTIVE INGREDIENTF850569PQRNALOXONE HYDROCHLORIDE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]3
NaloxoneACTIVE MOIETY36B82AMQ7NNALOXONE HYDROCHLORIDE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-1469NALOXONE HYDROCHLORIDE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]7Current NDC, Legacy NDC, 2 package rows20241222_236349ef-2cb5-47ca-a3a5-99534c3a4996.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSN236349ef-2cb5-47ca-a3a5-99534c3a49967
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCD236349ef-2cb5-47ca-a3a5-99534c3a49967
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSY236349ef-2cb5-47ca-a3a5-99534c3a49967
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSNea4ea2fe-af48-0b3c-e053-2a95a90a0ad53
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCDea4ea2fe-af48-0b3c-e053-2a95a90a0ad53
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSYea4ea2fe-af48-0b3c-e053-2a95a90a0ad53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76329-1469-17632914690110 SYRINGE in 1 BOX (76329-1469-1) / 2 mL in 1 SYRINGE10 syringe1998-04-010000-00-00NoNoCurrent