FDA.reportPublic FDA data

Esgic

Product NDC
68308-219
Requested package NDC
68308-219-01
11-digit product format
683080219
Labeler code
68308
Product ID
68308-219_ed0bf5f2-521e-27fe-e053-2995a90ab13b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butalbital, acetaminophen and caffeine
Dosage form
CAPSULE
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA089007
Marketing category
ANDA
Marketing start
2014-05-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength
325 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]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage68308-21968308-219-01DDiscontinued 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
A089007-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE325MG;50MG;40MGCAPSULE / ORALAARS1986-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089007-001AA

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 22:54:322026-06A089007-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGCAPSULE / ORALAARS1986-03-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A089007-001AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEMayne Pharmafa88f437-830b-48bc-a44c-fd142963a1502025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089007
application number: ANDA089007
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEDr. Reddy's Labratories Inc.69df02fa-c842-48dc-7ac6-5967b7dc30de2024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089007
application number: ANDA089007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-219-01EA - Each68308-219f5f7325d-6a36-4ea0-b22a-f5c8b0a53c5e12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2
BUTALBITALACTIVE MOIETYKHS0AZ4JVKESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2
CAFFEINEACTIVE MOIETY3G6A5W338EESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2
GELATININACTIVE INGREDIENT2G86QN327LESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESGIC (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) CAPSULE [MAYNE PHARMA INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68308-219-0168308021901100 CAPSULE in 1 BOTTLE, PLASTIC (68308-219-01) 100 capsule2014-05-010000-00-00NoNoCurrent