FDA.reportPublic FDA data

Acetaminophen

Product NDC
69848-015
11-digit product format
698480015
Labeler code
69848
Product ID
69848-015_4690a42a-ee23-e19b-e063-6294a90a2d9f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Granules USA, Inc.
Application
ANDA211544
Marketing category
ANDA
Marketing start
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69848-015-102020-12-30C16284748780-1ab0e2407-2606-f274-e053-dbdaa90a64718 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain
69848-015-102020-09-27C16284748780-1ab0e2407-2606-f274-e053-dbdaa90a64718 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain
69848-015-102020-09-25C16284748780-1ab0e2407-2606-f274-e053-dbdaa90a64718 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain
69848-015-102020-07-22C16284748780-1ab0e2407-2606-f274-e053-dbdaa90a64718 Hour Arthritis Pain Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69848-015-10Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1009
69848-015-24Acetaminophen24 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE249

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69848-015-10EA - Each69848-01562184175-7742-4377-bc10-d0028f27e01d12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69848-015ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [GRANULES USA, INC. ]8Current NDC, Legacy NDC, 2 package rows20241212_96131c7b-bdff-0642-e053-2a95a90a4f32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN96131c7b-bdff-0642-e053-2a95a90a4f329
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD96131c7b-bdff-0642-e053-2a95a90a4f329
11483998 HR APAP 650 MG Extended Release Oral TabletSY96131c7b-bdff-0642-e053-2a95a90a4f329
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY96131c7b-bdff-0642-e053-2a95a90a4f329

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69848-015-1069848001510100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-10) 2019-12-310000-00-00NoNoCurrent
69848-015-246984800152424 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-24) 2022-11-300000-00-00NoNoCurrent