NDC 13925-535

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Butalbital, Acetaminophen And Caffeine

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Seton Pharmaceuticals Llc. The primary component is Acetaminophen; Butalbital; Caffeine.

Product ID13925-535_2c971bd3-054a-4b71-ae99-9615ecd812f1
NDC13925-535
Product TypeHuman Prescription Drug
Proprietary NameBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Generic NameButalbital, Acetaminophen And Caffeine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-03-02
Marketing CategoryANDA /
Application NumberANDA214087
Labeler NameSeton Pharmaceuticals LLC
Substance NameACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active Ingredient Strength300 mg/1; mg/1; mg/1
Pharm ClassesBarbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 13925-535-01

100 CAPSULE in 1 BOTTLE (13925-535-01)
Marketing Start Date2022-03-02
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "BUTALBITAL, ACETAMINOPHEN AND CAFFEINE" or generic name "Butalbital, Acetaminophen And Caffeine"

NDCBrand NameGeneric Name
0143-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
0527-4094butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
0603-2544Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and Caffeine
0904-6538Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
10135-628Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
10702-253Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
11534-187BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
13107-075Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
13925-535BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
13925-536BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
17856-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
21695-257Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
21695-843Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
42195-955Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
42254-323Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and Caffeine
42543-094Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
43063-369Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
46672-053butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
46672-633butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
50090-2105Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
50268-139Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
50436-4856butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
51407-200BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeine
51407-556Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
51672-4222Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen, and caffeine
51862-179butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
68071-4657butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
68084-396BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
68151-1313Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
68788-9025Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
68788-9711butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
71335-0347butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
71610-042butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
51862-540butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
52959-913Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
55289-879Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
55154-7147BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
60429-589butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
61919-022BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINE
63187-520butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
66267-039butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeine
67544-394Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
67296-0718Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine
55154-7988Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and Caffeine

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