Naloxone Hydrochloride

Product NDC
17478-042
11-digit product format
174780042
Labeler code
17478
Product ID
17478-042_c169f27e-a661-4482-8303-0a0d4d811655
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Akorn
Application
ANDA208872
Marketing category
ANDA
Marketing start
2017-03-14
Marketing end
0000-00-00
Substance
NALOXONE HYDROCHLORIDE
Active strength
0 mg/mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-042-102024-01-30C16284748780-11030e365-6971-111a-e063-dadaa90a10e2Naloxone Hydrochloride Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-042-10Naloxone Hydrochloride10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1012
17478-042-10Naloxone Hydrochloride1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-042-10ML - Milliliter17478-0429b7fbb6a-9414-421d-b92e-592e81d8156712017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-042NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [AKORN]12Legacy NDC, 2 package rows20220915_747e602c-93f9-4723-a899-4c1c55c35ef8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659929naloxone HCl 0.4 MG in 1 ML InjectionPSN747e602c-93f9-4723-a899-4c1c55c35ef812
1191222naloxone HCl 0.4 MG/ML Injectable SolutionPSN747e602c-93f9-4723-a899-4c1c55c35ef812
16599291 ML naloxone hydrochloride 0.4 MG/ML InjectionSCD747e602c-93f9-4723-a899-4c1c55c35ef812
1191222naloxone hydrochloride 0.4 MG/ML Injectable SolutionSCD747e602c-93f9-4723-a899-4c1c55c35ef812
1659929naloxone HCl 0.4 MG per 1 ML InjectionSY747e602c-93f9-4723-a899-4c1c55c35ef812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-042-10174780042101 VIAL, MULTI-DOSE in 1 CARTON (17478-042-10) > 10 mL in 1 VIAL, MULTI-DOSE2017-03-140000-00-00NoNoCurrent