Acetaminophen

Product NDC
11822-5091
11-digit product format
118225091
Labeler code
11822
Product ID
11822-5091_4654d9ab-e6a0-5e9e-e063-6394a90a1e0e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RITE AID
Application
ANDA211544
Marketing category
ANDA
Marketing start
2024-11-01
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-5091-5Acetaminophen225 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE2257
11822-5091-6Acetaminophen50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5091ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [RITE AID]6Current NDC, Legacy NDC, 2 package rows20250322_d20a7f7a-febf-54f9-e053-2a95a90a06b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNd20a7f7a-febf-54f9-e053-2a95a90a06b17
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDd20a7f7a-febf-54f9-e053-2a95a90a06b17
11483998 HR APAP 650 MG Extended Release Oral TabletSYd20a7f7a-febf-54f9-e053-2a95a90a06b17
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYd20a7f7a-febf-54f9-e053-2a95a90a06b17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-5091-511822509105225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5091-5) 2024-11-010000-00-00NoNoCurrent
11822-5091-61182250910650 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5091-6) 2024-11-010000-00-00NoNoCurrent