Duralgina

Product NDC
53145-013
11-digit product format
531450013
Labeler code
53145
Product ID
53145-013_3a893b13-e7ee-c5b1-e063-6394a90a4253
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Menper Distributors Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-01
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Duralgina
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui313782

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-013-712020-01-31C16284748780-19d75b9d0-b84e-f424-e053-dadaa90a57ceDuralgina

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-013-71Duralgina30 in 1 BOTTLETABLET3011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSNbb31f66c-80a9-4bdb-983b-cef5d21de5ff11
313782acetaminophen 325 MG Oral TabletSCDbb31f66c-80a9-4bdb-983b-cef5d21de5ff11
313782APAP 325 MG Oral TabletSYbb31f66c-80a9-4bdb-983b-cef5d21de5ff11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53145-013-715314500137130 TABLET in 1 BOTTLE (53145-013-71) 30 tablet2017-01-01NoNoHistorical