Acetaminophen

Product NDC
68001-495
11-digit product format
680010495
Labeler code
68001
Product ID
68001-495_1a273bc1-09a5-3877-e063-6394a90a9388
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA207229
Marketing category
ANDA
Marketing start
2021-04-30
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
68001-495-00Acetaminophen1 in 1 CARTONTABLET13
68001-495-00Acetaminophen100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-495-00EA - Each68001-49583c3754a-4353-4a7b-8c71-91f6b2403cbb12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-495ACETAMINOPHEN TABLET [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 2 package rows20240613_c065c531-88f5-0930-e053-2a95a90ae861.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNc065c531-88f5-0930-e053-2a95a90ae8613
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDc065c531-88f5-0930-e053-2a95a90ae8613
11483998 HR APAP 650 MG Extended Release Oral TabletSYc065c531-88f5-0930-e053-2a95a90ae8613
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYc065c531-88f5-0930-e053-2a95a90ae8613
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN88e5345a-f240-473c-b329-2b0aa5f081f91
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD88e5345a-f240-473c-b329-2b0aa5f081f91
11483998 HR APAP 650 MG Extended Release Oral TabletSY88e5345a-f240-473c-b329-2b0aa5f081f91
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY88e5345a-f240-473c-b329-2b0aa5f081f91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-495-00680010495001 BOTTLE in 1 CARTON (68001-495-00) / 100 TABLET in 1 BOTTLE1 bottle2021-04-300000-00-00NoNoCurrent