Nalbuphine Hydrochloride

Product NDC
63739-466
11-digit product format
637390466
Labeler code
63739
Product ID
63739-466_f0ca2945-6766-47c7-a886-01f4aee694f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NALBUPHINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA070916
Marketing category
ANDA
Marketing start
2004-12-31
Marketing end
0000-00-00
Substance
NALBUPHINE HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-466-05ML - Milliliter63739-46647aa7882-3f38-4b84-b55b-72a47e30785212012-07-24
63739-466-21ML - Milliliter63739-4663dae08a6-1880-4b93-a083-62f8545c9b5f12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-466-05637390466055 AMPULE in 1 BOX (63739-466-05) > 1 mL in 1 AMPULE5 ampule2004-12-310000-00-00NoNoCurrent