Naloxone Hydrochloride

Product NDC
67457-599
11-digit product format
674570599
Labeler code
67457
Product ID
67457-599_fde9e80c-8167-4812-a1d6-c614f9a98592
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
2014-12-17
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-599-00ML - Milliliter67457-5996bb40764-8fb8-4cd4-b1ef-97dffc7d683212015-01-05
67457-599-02ML - Milliliter67457-59910f19ea2-2d6d-44a4-8277-58543ee90b2512015-01-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-599NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]10Legacy NDC20241004_307ae923-3c84-4844-9bbb-c5c5528623ac.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-599-026745705990210 VIAL, SINGLE-DOSE in 1 CARTON (67457-599-02) > 1 mL in 1 VIAL, SINGLE-DOSE (67457-599-00) 2014-12-170000-00-00NoNoCurrent