butalbital and acetaminophen

Product NDC
47781-644
11-digit product format
477810644
Labeler code
47781
Product ID
47781-644_84a68c8b-4f68-5b36-f8f7-794a557fc7c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butalbital and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA207635
Marketing category
ANDA
Marketing start
2019-12-03
Marketing end
2022-09-01
Substance
BUTALBITAL; ACETAMINOPHEN
Active strength
50 mg/1; mg/1
Pharmacologic classes
Barbiturates [CS],Barbiturate [EPC]
DEA schedule
CIII
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
47781-644-01EA - Each47781-6440e7a425e-b0ce-4132-b3b9-09079606880212020-01-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-644-0147781064401100 TABLET in 1 BOTTLE (47781-644-01) 100 tablet2019-12-030000-00-00NoNoCurrent