ACETAMINOPHEN

Product NDC
70010-160
11-digit product format
700100160
Labeler code
70010
Product ID
70010-160_451b5125-968f-8c11-e063-6294a90a447c
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA211544
Marketing category
ANDA
Marketing start
2022-02-15
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
70010-160-01ACETAMINOPHEN100 in 1 BOTTLETABLET, EXTENDED RELEASE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-160-01EA - Each70010-160e99b1821-5a57-4586-bde1-c350e40a266612022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-160ACETAMINOPHEN TABLET, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 1 package rows20230129_d5352861-6926-f1b0-e053-2a95a90a7d66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNd5352861-6926-f1b0-e053-2a95a90a7d665
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDd5352861-6926-f1b0-e053-2a95a90a7d665
11483998 HR APAP 650 MG Extended Release Oral TabletSYd5352861-6926-f1b0-e053-2a95a90a7d665
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYd5352861-6926-f1b0-e053-2a95a90a7d665
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNa3217b48-7482-4cc7-8811-ae75fd9d78051
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDa3217b48-7482-4cc7-8811-ae75fd9d78051
11483998 HR APAP 650 MG Extended Release Oral TabletSYa3217b48-7482-4cc7-8811-ae75fd9d78051
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYa3217b48-7482-4cc7-8811-ae75fd9d78051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-160-0170010016001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-160-01) 2022-02-150000-00-00NoNoCurrent