FDA.reportPublic FDA data

Butalbital, Acetaminophen, Caffeine

Product NDC
50268-553
11-digit product format
502680553
Labeler code
50268
Product ID
50268-553_2b4a7d93-e919-27be-e063-6294a90a1db0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA209587
Marketing category
ANDA
Marketing start
2022-08-11
Substance
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength
325; 50; 40 mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Butalbital, Acetaminophen, Caffeine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
BUTALBITAL50 mg/1
CAFFEINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E
Rxcui238154

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-553-11Butalbital, Acetaminophen, Caffeine1 in 1 BLISTER PACKTABLET13
50268-553-13Butalbital, Acetaminophen, Caffeine30 in 1 BOXTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-553-11EA - Each50268-55390bf7986-3279-448f-9868-db8e333b5dcc12022-09-12
50268-553-13EA - Each50268-553c98dc43f-9abf-452e-beed-5515649e925212022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-553BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [AVPAK]3Current NDC, Legacy NDC, 2 package rows20250112_e5fbd6b8-85e7-8847-e053-2a95a90a52ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNe5fbd6b8-85e7-8847-e053-2a95a90a52ed3
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDe5fbd6b8-85e7-8847-e053-2a95a90a52ed3
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYe5fbd6b8-85e7-8847-e053-2a95a90a52ed3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-553-11502680553111 in 1 BLISTER PACKHistorical
50268-553-135026805531330 BLISTER PACK in 1 BOX (50268-553-13) / 1 TABLET in 1 BLISTER PACK (50268-553-11) 30 blister pack2022-08-110000-00-00NoNoCurrent