FDA.reportPublic FDA data

Biogesic

Product NDC
45737-610
11-digit product format
457370610
Labeler code
45737
Product ID
45737-610_8c3e3753-dfc7-4cfe-9c04-b7f8a8cfd75f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dexbrompheniramine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Generic Corporation
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-01-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
Active strength
500 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45737-610IInactivated by FDA2026-08-17
excluded packagepackage45737-61045737-610-10IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage45737-610-10e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45737-610-109bebd1f3094a…5416666fcb17…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-610-102020-12-23C16284748780-19d75b9d0-56b9-f424-e053-dadaa90a57ceAGC-Biogesic Tab 610
45737-610-102020-01-31C16284748780-19d75b9d0-56b9-f424-e053-dadaa90a57ceAGC-Biogesic Tab 610

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-610-10Biogesic100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-610BIOGESIC (ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE) TABLET [ADVANCED GENERIC CORPORATION]3Legacy NDC, 1 package rows20241222_fdfebc9f-4775-4da4-9bb0-8175e67f93c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletPSNfdfebc9f-4775-4da4-9bb0-8175e67f93c43
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletSCDfdfebc9f-4775-4da4-9bb0-8175e67f93c43
1798453APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral TabletSYfdfebc9f-4775-4da4-9bb0-8175e67f93c43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45737-610-1045737061010100 TABLET in 1 BOTTLE (45737-610-10) 100 tablet2017-01-010000-00-00NoNoCurrent