FDA.reportPublic FDA data

Acetaminophen

Product NDC
49035-181
11-digit product format
490350181
Labeler code
49035
Product ID
49035-181_464fd9d1-4a10-0fb1-e063-6394a90a933d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
WAL-MART STORES INC
Application
ANDA211544
Marketing category
ANDA
Marketing start
2019-10-04
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
49035-181-212020-12-29C16284748780-1ab0e2407-335b-f274-e053-dbdaa90a6471Arthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours
49035-181-212020-09-27C16284748780-1ab0e2407-335b-f274-e053-dbdaa90a6471Arthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours
49035-181-212020-09-25C16284748780-1ab0e2407-335b-f274-e053-dbdaa90a6471Arthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours
49035-181-212020-07-22C16284748780-1ab0e2407-335b-f274-e053-dbdaa90a6471Arthritis Pain Reliever ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg PAIN RELIEVER / FEVER REDUCER ARTHRITIS 8 HOUR CAPLETS - For the temporary relief of minor arthritis pain - Lasts up to 8 hours

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-181-21Acetaminophen225 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE2257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-181ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [WAL-MART STORES INC]5Current NDC, Legacy NDC, 1 package rows20241212_940936ac-e59f-7489-e053-2a95a90a6364.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN940936ac-e59f-7489-e053-2a95a90a63647
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD940936ac-e59f-7489-e053-2a95a90a63647
11483998 HR APAP 650 MG Extended Release Oral TabletSY940936ac-e59f-7489-e053-2a95a90a63647
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY940936ac-e59f-7489-e053-2a95a90a63647

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49035-181-2149035018121225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (49035-181-21) 2019-10-040000-00-00NoNoCurrent