Butalbital and Acetaminophen

Product NDC
71993-301
11-digit product format
719930301
Labeler code
71993
Product ID
71993-301_9d4d3295-b486-bf0c-e053-2995a90a2cd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Atland Pharmaceuticals, LLC
Application
ANDA203484
Marketing category
ANDA
Marketing start
2020-01-30
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
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
71993-301-10EA - Each71993-3016a922fea-1508-47be-b0a8-86878ef295a212020-02-13
71993-301-30EA - Each71993-301cb355ff5-8010-40b6-846e-fc9f2246f7d012020-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71993-301-1071993030110100 TABLET in 1 BOTTLE, PLASTIC (71993-301-10) 100 tablet2020-01-300000-00-00NoNoCurrent
71993-301-307199303013030 TABLET in 1 BOTTLE, PLASTIC (71993-301-30) 30 tablet2020-01-300000-00-00NoNoCurrent