Extra Strength Acetaminophen

Product NDC
51013-320
11-digit product format
510130320
Labeler code
51013
Product ID
51013-320_1b2f1b11-905c-4c77-b609-ffae53749092
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PuraCap Pharmaceutical LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-11-09
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Extra Strength Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-320-54Extra Strength Acetaminophen2 in 1 POUCHTABLET, FILM COATED21
51013-320-54Extra Strength Acetaminophen15 in 1 CARTONTABLET, FILM COATED151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-320EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [PURACAP PHARMACEUTICAL LLC]1Current NDC, Legacy NDC, 2 package rows20171110_f3c57374-1408-4459-a4de-ad12c2fc6b61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNf3c57374-1408-4459-a4de-ad12c2fc6b611
198440acetaminophen 500 MG Oral TabletSCDf3c57374-1408-4459-a4de-ad12c2fc6b611
198440APAP 500 MG Oral TabletSYf3c57374-1408-4459-a4de-ad12c2fc6b611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-320-545101303205415 POUCH in 1 CARTON (51013-320-54) / 2 TABLET, FILM COATED in 1 POUCH15 pouch2017-11-090000-00-00NoNoCurrent