Butalbital, Acetaminophen, and Caffeine

Product NDC
55700-662
11-digit product format
557000662
Labeler code
55700
Product ID
55700-662_96202291-bbea-4fd7-94da-18cf01b8ee23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA200243
Marketing category
ANDA
Marketing start
2018-07-26
Marketing end
0000-00-00
Substance
BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength
50 mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2020-12-31
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
55700-662-30EA - Each55700-662f59f58b9-4b40-4556-a199-0e2e8a775dc212018-09-05
55700-662-60EA - Each55700-6622cac491a-5667-408f-90c1-3d571a074c6b12019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-662-305570006623030 TABLET in 1 BOTTLE, PLASTIC (55700-662-30) 30 tablet2018-07-260000-00-00NoNoCurrent