Naloxone Hydrochloride

Product NDC
0781-7176
11-digit product format
007817176
Labeler code
0781
Product ID
0781-7176_1031b5cb-200d-4478-b754-6391ea5067a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naloxone Hydrochloride Nasal Spray
Dosage form
INHALANT
Route
NASAL
Labeler
Sandoz Inc.
Application
NDA208411
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-12-20
Marketing end
0000-00-00
Substance
NALOXONE HYDROCHLORIDE
Active strength
4 mg/.1mL
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-7176-06EA - Each0781-7176d47252ad-0dea-4c26-9358-46b97f7bc11712022-01-06
0781-7176-12EA - Each0781-7176b14d31ff-6c88-480f-a96d-aaf0bd88a1ac12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-7176NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE NASAL SPRAY) INHALANT [SANDOZ INC.]2Legacy NDC20220105_68723486-8f21-4299-b380-7d5e3f9657b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN4517afa1-4b17-4a15-b91b-65b18bd0558f3
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD4517afa1-4b17-4a15-b91b-65b18bd0558f3
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY4517afa1-4b17-4a15-b91b-65b18bd0558f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-7176-12007817176122 VIAL, SINGLE-DOSE in 1 CARTON (0781-7176-12) > .1 mL in 1 VIAL, SINGLE-DOSE (0781-7176-06) 2021-12-200000-00-00NoNoCurrent