Butorphanol Tartrate

Product NDC
0378-9639
11-digit product format
003789639
Labeler code
0378
Product ID
0378-9639_2bc7dc31-b73f-4b83-8dc2-85353ad831c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butorphanol tartrate
Dosage form
SPRAY
Route
NASAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075759
Marketing category
ANDA
Marketing start
2011-01-21
Marketing end
2021-10-31
Substance
BUTORPHANOL TARTRATE
Active strength
10 mg/mL
Pharmacologic classes
Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9639-43ML - Milliliter0378-9639c8fd6d1f-1df1-49bb-b94a-bc61129a642e12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-9639-43003789639432.5 mL in 1 VIAL, MULTI-DOSE (0378-9639-43) 2.5 ml2011-01-210000-00-00NoNoCurrent