FDA.reportPublic FDA data

naloxone hydrochloride

Product NDC
36000-308
11-digit product format
360000308
Labeler code
36000
Product ID
36000-308_ad8223dd-206d-4fd8-b0fb-de10e970a9e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA214785
Marketing category
ANDA
Marketing start
2021-01-29
Substance
NALOXONE HYDROCHLORIDE
Active strength
.4 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 HYDROCHLORIDE.4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF850569PQR
Rxcui1659929

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
36000-308-01naloxone hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION110
36000-308-10naloxone hydrochloride10 in 1 CARTONINJECTION, SOLUTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36000-308-01ML - Milliliter36000-308984cdc81-2734-41bc-ad91-a54c16c3030a12021-12-08
36000-308-10ML - Milliliter36000-308ce1ebcdf-b0a1-4753-9890-76a0fa0d5ae712021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-308NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]8Current NDC, Legacy NDC, 2 package rows20240806_d04ae2d7-01b9-405d-bb7a-bf2d876ce26a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659929naloxone HCl 0.4 MG in 1 ML InjectionPSNd04ae2d7-01b9-405d-bb7a-bf2d876ce26a10
16599291 ML naloxone hydrochloride 0.4 MG/ML InjectionSCDd04ae2d7-01b9-405d-bb7a-bf2d876ce26a10
1659929naloxone HCl 0.4 MG per 1 ML InjectionSYd04ae2d7-01b9-405d-bb7a-bf2d876ce26a10
1659929naloxone HCl 0.4 MG in 1 ML InjectionPSNfa1ca55b-f56b-0d9b-e053-6294a90a258a1
16599291 ML naloxone hydrochloride 0.4 MG/ML InjectionSCDfa1ca55b-f56b-0d9b-e053-6294a90a258a1
1659929naloxone HCl 0.4 MG per 1 ML InjectionSYfa1ca55b-f56b-0d9b-e053-6294a90a258a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36000-308-01360000308011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
36000-308-103600003081010 VIAL, SINGLE-DOSE in 1 CARTON (36000-308-10) / 1 mL in 1 VIAL, SINGLE-DOSE (36000-308-01) 2021-01-290000-00-00NoNoCurrent