FDA.reportPublic FDA data

Butalbital, Acetaminophen and Caffeine

Product NDC
13107-075
11-digit product format
131070075
Labeler code
13107
Product ID
13107-075_bc2de4b3-7c0d-48db-b6e1-ee41bfad08e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen and Caffeine
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA204733
Marketing category
ANDA
Marketing start
2017-04-26
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

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
A204733-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE325MG;50MG;40MGCAPSULE / ORALAA2018-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204733-001AA

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 22:54:322026-06A204733-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGCAPSULE / ORALAA2018-09-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204733-001AA1a50c72e98297…

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, Acetaminophen and CaffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAurolife Pharma, LLCf9fde75d-7def-48fc-a2b0-727f677f60012025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204733
application number: ANDA204733
ndc (product): 13107-075

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTALBITAL325 mg/1
ACETAMINOPHEN50 mg/1
CAFFEINE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KHS0AZ4JVKInternal UNII lookup
362O9ITL9DInternal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238153Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9fde75d-7def-48fc-a2b0-727f677f6001Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13107-075-012025-01-15C16284748780-1f386c64a-3db7-0266-e053-dadaa90a7c1aButalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only
13107-075-052025-01-15C16284748780-1f386c64a-3db7-0266-e053-dadaa90a7c1aButalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only
13107-075-302025-01-15C16284748780-1f386c64a-3db7-0266-e053-dadaa90a7c1aButalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only
13107-075-012023-01-30C16284748780-1f386c64a-3db7-0266-e053-dadaa90a7c1aButalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only
13107-075-052023-01-30C16284748780-1f386c64a-3db7-0266-e053-dadaa90a7c1aButalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only
13107-075-302023-01-30C16284748780-1f386c64a-3db7-0266-e053-dadaa90a7c1aButalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/325 mg/40 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-075-01Butalbital, Acetaminophen and Caffeine100 in 1 BOTTLECAPSULE1005
13107-075-05Butalbital, Acetaminophen and Caffeine500 in 1 BOTTLECAPSULE5005
13107-075-30Butalbital, Acetaminophen and Caffeine30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-075-01EA - Each13107-0754bf0de71-54d4-4229-88fd-b9bbb3cfb7fb12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-075BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [AUROLIFE PHARMA, LLC]5Current NDC, Legacy NDC, 3 package rows20250417_f9fde75d-7def-48fc-a2b0-727f677f6001.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238153butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral CapsulePSNf9fde75d-7def-48fc-a2b0-727f677f60015
238153acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral CapsuleSCDf9fde75d-7def-48fc-a2b0-727f677f60015
238153APAP 325 MG / butalbital 50 MG / Caffeine 40 MG Oral CapsuleSYf9fde75d-7def-48fc-a2b0-727f677f60015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-075-0113107007501100 CAPSULE in 1 BOTTLE (13107-075-01) 100 capsule2017-04-260000-00-00NoNoCurrent
13107-075-0513107007505500 CAPSULE in 1 BOTTLE (13107-075-05) 500 capsule2017-04-260000-00-00NoNoCurrent
13107-075-301310700753030 CAPSULE in 1 BOTTLE (13107-075-30) 30 capsule2017-04-260000-00-00NoNoCurrent