butalbital and acetaminophen

Product NDC
68047-722
11-digit product format
680470722
Labeler code
68047
Product ID
68047-722_cddc7e52-4eb8-7f7d-e053-2a95a90a2c5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butalbital and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Larken Laboratories, Inc.
Application
ANDA203484
Marketing category
ANDA
Marketing start
2015-12-04
Marketing end
0000-00-00
Substance
BUTALBITAL; ACETAMINOPHEN
Active strength
25 mg/1; mg/1
Pharmacologic classes
Barbiturates [CS],Barbiturate [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68047-722-0168047072201100 TABLET in 1 BOTTLE (68047-722-01) 100 tablet2015-12-040000-00-00NoNoCurrent