ACETAMINOPHEN

Product NDC
57896-268
11-digit product format
578960268
Labeler code
57896
Product ID
57896-268_1dee586b-62df-bc69-e063-6394a90aa329
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
GERI-CARE PHARMACEUTICAL CORP
Application
ANDA211544
Marketing category
ANDA
Marketing start
2019-07-01
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
57896-268-01ACETAMINOPHEN100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-268-01EA - Each57896-2687feebf9b-706d-4d37-b868-4323442eca8b12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-268ACETAMINOPHEN TABLET, EXTENDED RELEASE [GERI-CARE PHARMACEUTICAL CORP]2Current NDC, Legacy NDC, 1 package rows20240724_92c22593-daf9-20a8-e053-2a95a90a365d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNf6dc5576-9ba3-436c-87f5-8d0d6258adef6
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDf6dc5576-9ba3-436c-87f5-8d0d6258adef6
11483998 HR APAP 650 MG Extended Release Oral TabletSYf6dc5576-9ba3-436c-87f5-8d0d6258adef6
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYf6dc5576-9ba3-436c-87f5-8d0d6258adef6
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN92c22593-daf9-20a8-e053-2a95a90a365d2
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD92c22593-daf9-20a8-e053-2a95a90a365d2
11483998 HR APAP 650 MG Extended Release Oral TabletSY92c22593-daf9-20a8-e053-2a95a90a365d2
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY92c22593-daf9-20a8-e053-2a95a90a365d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57896-268-0157896026801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (57896-268-01) 2019-07-010000-00-00NoNoCurrent