Acetaminophen

Product NDC
11822-5019
11-digit product format
118225019
Labeler code
11822
Product ID
11822-5019_2bd9f035-2806-299c-e063-6394a90ac041
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
11822-5019-2Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1005
11822-5019-3Acetaminophen50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE505
11822-5019-4Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5019ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [RITE AID]5Current NDC, Legacy NDC, 2 package rows20250119_d1f18c32-c043-7c97-e053-2a95a90a203e.zip
11822-5019ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [RITE AID]2Current NDC, Legacy NDC, 1 package rows20250322_d20b4682-fed2-3ea2-e053-2995a90aa47e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNd1f18c32-c043-7c97-e053-2a95a90a203e5
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDd1f18c32-c043-7c97-e053-2a95a90a203e5
11483998 HR APAP 650 MG Extended Release Oral TabletSYd1f18c32-c043-7c97-e053-2a95a90a203e5
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYd1f18c32-c043-7c97-e053-2a95a90a203e5
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNd20b4682-fed2-3ea2-e053-2995a90aa47e3
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDd20b4682-fed2-3ea2-e053-2995a90aa47e3
11483998 HR APAP 650 MG Extended Release Oral TabletSYd20b4682-fed2-3ea2-e053-2995a90aa47e3
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYd20b4682-fed2-3ea2-e053-2995a90aa47e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-5019-211822501902100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5019-2) 2024-11-010000-00-00NoNoCurrent
11822-5019-31182250190350 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5019-3) 2024-11-010000-00-00NoNoCurrent
11822-5019-411822501904100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5019-4) 2021-11-300000-00-00NoNoCurrent