Acetaminophen

Product NDC
0904-7314
11-digit product format
009047314
Labeler code
0904
Product ID
0904-7314_465309f8-55b3-9cbf-e063-6294a90a8ca8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
MAJOR PHARMACEUTICALS
Application
ANDA211544
Marketing category
ANDA
Marketing start
2023-03-03
Substance
ACETAMINOPHEN
Active strength
650 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
Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7314-27Acetaminophen400 in 1 BOTTLETABLET4007
0904-7314-60Acetaminophen100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7314-27EA - Each0904-73143f21828f-6576-4535-9968-2f773761d17d12023-04-07
0904-7314-60EA - Each0904-73147de0876c-03e2-4c5a-93b7-076b93c7b1c912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7314ACETAMINOPHEN TABLET [MAJOR PHARMACEUTICALS]5Current NDC, 2 package rows20241120_efd0a432-abbb-1f88-e053-2995a90a8ce5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNefd0a432-abbb-1f88-e053-2995a90a8ce57
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDefd0a432-abbb-1f88-e053-2995a90a8ce57
11483998 HR APAP 650 MG Extended Release Oral TabletSYefd0a432-abbb-1f88-e053-2995a90a8ce57
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYefd0a432-abbb-1f88-e053-2995a90a8ce57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7314-2700904731427400 TABLET in 1 BOTTLE (0904-7314-27) 400 tablet2023-03-03NoNoHistorical
0904-7314-6000904731460100 TABLET in 1 BOTTLE (0904-7314-60) 100 tablet2023-03-03NoNoHistorical