FDA.reportPublic FDA data

Naloxone Hydrochloride

Product NDC
67457-292
11-digit product format
674570292
Labeler code
67457
Product ID
67457-292_292c264d-927b-43a6-b9eb-00154f5d13de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Mylan Institutional LLC
Application
ANDA204997
Marketing category
ANDA
Marketing start
2014-03-06
Substance
NALOXONE HYDROCHLORIDE
Active strength
.4 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 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
67457-292-00Naloxone Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION110
67457-292-02Naloxone Hydrochloride10 in 1 CARTONINJECTION, SOLUTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-292-00ML - Milliliter67457-292b554b8ba-888d-4dba-98de-87dfb4ce0d7c12014-04-03
67457-292-02ML - Milliliter67457-292cfbdd5bf-e79f-4469-b4b4-b0f4b1b86f7b12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NALOXONE HYDROCHLORIDEACTIVE INGREDIENTF850569PQRNALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
NALOXONEACTIVE MOIETY36B82AMQ7NNALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
WATERINACTIVE INGREDIENT059QF0KO0RNALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-292NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]10Current NDC, Legacy NDC, 2 package rows20210427_f0932877-1f3b-4d5e-82d2-dd6c53db4730.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659929naloxone HCl 0.4 MG in 1 ML InjectionPSNf0932877-1f3b-4d5e-82d2-dd6c53db473010
16599291 ML naloxone hydrochloride 0.4 MG/ML InjectionSCDf0932877-1f3b-4d5e-82d2-dd6c53db473010
1659929naloxone HCl 0.4 MG per 1 ML InjectionSYf0932877-1f3b-4d5e-82d2-dd6c53db473010
1659929naloxone HCl 0.4 MG in 1 ML InjectionPSN3d2dcee4-7510-477b-95a8-9b2afb7739841
16599291 ML naloxone hydrochloride 0.4 MG/ML InjectionSCD3d2dcee4-7510-477b-95a8-9b2afb7739841
1659929naloxone HCl 0.4 MG per 1 ML InjectionSY3d2dcee4-7510-477b-95a8-9b2afb7739841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-292-00674570292001 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
67457-292-026745702920210 VIAL, SINGLE-DOSE in 1 CARTON (67457-292-02) / 1 mL in 1 VIAL, SINGLE-DOSE (67457-292-00) 2014-03-060000-00-00NoNoCurrent