FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
71399-1026
11-digit product format
713991026
Labeler code
71399
Product ID
71399-1026_4f210590-1639-3728-e063-6394a90aff3d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Akron Pharma Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-06
Substance
ACETAMINOPHEN
Active strength
500 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
ACETAMINOPHEN
Listing expiration
2027-12-31

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
71399-1026-1ACETAMINOPHEN100 in 1 BOTTLETABLET1004
71399-1026-2ACETAMINOPHEN1000 in 1 BOTTLETABLET10004
71399-1026-8ACETAMINOPHEN100000 in 1 DRUMTABLET1000004
71399-1026-9ACETAMINOPHEN60000 in 1 DRUMTABLET600004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-1026-1EA - Each71399-1026d294f43e-7258-42a3-b402-1ca9f725758512025-02-10
71399-1026-2EA - Each71399-1026c2702949-aff5-492f-8577-24cc21a5c2b212025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-1026ACETAMINOPHEN TABLET [AKRON PHARMA INC.]1Current NDC, 4 package rows20241210_ab79fd60-8315-4c63-8045-1b0511ac268f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNab79fd60-8315-4c63-8045-1b0511ac268f4
198440acetaminophen 500 MG Oral TabletSCDab79fd60-8315-4c63-8045-1b0511ac268f4
198440APAP 500 MG Oral TabletSYab79fd60-8315-4c63-8045-1b0511ac268f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-1026-171399102601100 TABLET in 1 BOTTLE (71399-1026-1) 100 tablet2024-12-06NoNoHistorical
71399-1026-2713991026021000 TABLET in 1 BOTTLE (71399-1026-2) 1000 tablet2024-12-06NoNoHistorical
71399-1026-871399102608100000 TABLET in 1 DRUM (71399-1026-8) 100000 tablet2024-12-06NoNoHistorical
71399-1026-97139910260960000 TABLET in 1 DRUM (71399-1026-9) 60000 tablet2024-12-06NoNoHistorical