FDA.reportPublic FDA data

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate

Product NDC
68047-720
Requested package NDC
68047-720-01
11-digit product format
680470720
Labeler code
68047
Product ID
68047-720_bd1c4613-5a42-f79d-e053-2995a90aba31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate
Dosage form
TABLET
Route
ORAL
Labeler
Larken Laboratories Inc.
Application
ANDA204209
Marketing category
ANDA
Marketing start
2016-10-04
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
Active strength
325 mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
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 packagepackage68047-72068047-720-01DDiscontinued 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
A204209-001ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATEACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE325MG;30MG;16MGTABLET / ORAL2016-09-30

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 22:54:322026-06A204209-001ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE325MG;30MG;16MGTABLET / ORAL2016-09-30a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68047-720-01EA - Each68047-72076dab56c-d7d3-4a0f-ac62-a5864fce61fb12017-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68047-720-0168047072001100 TABLET in 1 BOTTLE (68047-720-01) 100 tablet2016-10-040000-00-00NoNoCurrent