FDA.reportPublic FDA data

BUPAP

Product NDC
0095-3000
Requested package NDC
0095-3000-01
11-digit product format
000953000
Labeler code
0095
Product ID
0095-3000_16609ec3-578a-4f92-83d4-85d58e23cd8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital and Acetaminophen Tablets
Dosage form
TABLET
Route
ORAL
Labeler
Bausch Health US, LLC
Application
ANDA090956
Marketing category
ANDA
Marketing start
2013-06-24
Marketing end
0000-00-00
Substance
BUTALBITAL; ACETAMINOPHEN
Active strength
50 mg/1; mg/1
Pharmacologic classes
Barbiturates [CS],Barbiturate [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0095-30000095-3000-01DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090956-001BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITAL300MG;50MGTABLET / ORALAARS2011-08-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090956-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090956-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGTABLET / ORALAARS2011-08-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090956-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butalbital and AcetaminophenBUTALBITAL AND ACETAMINOPHEN TABLETSOceanside Pharmaceuticalsd2213ffd-18f6-45f5-9af7-690a977562c42020-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090956
application number: ANDA090956

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0095-3000-01EA - Each0095-3000f950a878-aa5f-407f-86f1-b547c0de34b412013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUPAP (BUTALBITAL AND ACETAMINOPHEN TABLETS) TABLET [ECR PHARMACEUTICALS]7
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUPAP (BUTALBITAL AND ACETAMINOPHEN TABLETS) TABLET [ECR PHARMACEUTICALS]7
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUPAP (BUTALBITAL AND ACETAMINOPHEN TABLETS) TABLET [ECR PHARMACEUTICALS]7
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUPAP (BUTALBITAL AND ACETAMINOPHEN TABLETS) TABLET [ECR PHARMACEUTICALS]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPAP (BUTALBITAL AND ACETAMINOPHEN TABLETS) TABLET [ECR PHARMACEUTICALS]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUPAP (BUTALBITAL AND ACETAMINOPHEN TABLETS) TABLET [ECR PHARMACEUTICALS]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUPAP (BUTALBITAL AND ACETAMINOPHEN TABLETS) TABLET [ECR PHARMACEUTICALS]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPAP (BUTALBITAL AND ACETAMINOPHEN TABLETS) TABLET [ECR PHARMACEUTICALS]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPAP (BUTALBITAL AND ACETAMINOPHEN TABLETS) TABLET [ECR PHARMACEUTICALS]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUPAP (BUTALBITAL AND ACETAMINOPHEN TABLETS) TABLET [ECR PHARMACEUTICALS]7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0095-3000-0100095300001100 TABLET in 1 BOTTLE, PLASTIC (0095-3000-01) 100 tablet2013-06-240000-00-00NoNoCurrent