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Butalbital And Acetaminophen

Butalbital and Acetaminophen 50 mg/ 325 mg tablet Butalbital and Acetaminophen 25 mg/ 325 mg tablet ALLZITAL (butalbital and acetaminophen 25 mg/ 325 mg) tablet Rx only

Approved
Approval ID

326c83fc-afed-45ad-9c87-f47968fa1d2a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 11, 2023

Manufacturers
FDA

Larken Laboratories, Inc.

DUNS: 149484540

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

butalbital and acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68047-753
Application NumberANDA203484
Product Classification
M
Marketing Category
C73584
G
Generic Name
butalbital and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification

INGREDIENTS (10)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
BUTALBITALActive
Quantity: 25 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB

butalbital and acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68047-752
Application NumberANDA203484
Product Classification
M
Marketing Category
C73584
G
Generic Name
butalbital and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification

INGREDIENTS (10)

CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
BUTALBITALActive
Quantity: 25 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT

butalbital and acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68047-721
Application NumberANDA203484
Product Classification
M
Marketing Category
C73584
G
Generic Name
butalbital and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification

INGREDIENTS (10)

BUTALBITALActive
Quantity: 50 mg in 1 1
Code: KHS0AZ4JVK
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 7/18/2022

HOW SUPPLIED

Butalbital and Acetaminophen, 50 mg/ 325 mg: White, capsule shaped tablet debossed “LL 721” on one side and plain on the other, in bottles
of 30 tablets (NDC 68047-721-30), and 100 tablets (NDC 68047-721-01).

Butalbital and Acetaminophen, 25 mg / 325 mg: White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles
of 30 tablets (NDC 68047-753-30) and 100 tablets (NDC 68047-753-01).

ALLZITAL (butalbital and acetaminophen, 25 mg / 325 mg): White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles of 30 tablets (NDC 68047-752-30) and 100 tablets (NDC 68047-752-01).

Storage:

Protect from light and moisture. Store Butalbital and Acetaminophen tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).

Dispense in a tight, light-resistant container with a child-resistant closure.

Distributed by:
Larken Laboratories, Inc.
Canton, MS 39046
www.larkenlabs.com

Rev. 06/2022
500411-07

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Butalbital And Acetaminophen - FDA Drug Approval Details