FDA.reportPublic FDA data

Acetaminophen

Product NDC
0363-9993
11-digit product format
003639993
Labeler code
0363
Product ID
0363-9993_465302c4-3a36-5be5-e063-6394a90a317d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
WALGREENS CO.
Application
ANDA211544
Marketing category
ANDA
Marketing start
2019-09-28
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
0363-9993-152020-12-29C16284748780-1ab0e2407-273e-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
0363-9993-212020-12-29C16284748780-1ab0e2407-273e-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
0363-9993-152020-09-27C16284748780-1ab0e2407-273e-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
0363-9993-212020-09-27C16284748780-1ab0e2407-273e-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
0363-9993-152020-09-25C16284748780-1ab0e2407-273e-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
0363-9993-212020-09-25C16284748780-1ab0e2407-273e-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
0363-9993-152020-07-22C16284748780-1ab0e2407-273e-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
0363-9993-212020-07-22C16284748780-1ab0e2407-273e-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
0363-9993-15Acetaminophen150 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE15010
0363-9993-21Acetaminophen225 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE22510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-9993-15EA - Each0363-999390f11c20-3032-4520-a93b-9e423bb8062212022-06-06
0363-9993-21EA - Each0363-9993465e1a5b-9f2a-4b57-bef9-5aa469cd57f712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9993ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [WALGREENS CO.]9Current NDC, Legacy NDC, 2 package rows20241218_8dba6ae0-1bfb-84de-e053-2a95a90aae46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN8dba6ae0-1bfb-84de-e053-2a95a90aae4610
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD8dba6ae0-1bfb-84de-e053-2a95a90aae4610
11483998 HR APAP 650 MG Extended Release Oral TabletSY8dba6ae0-1bfb-84de-e053-2a95a90aae4610
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY8dba6ae0-1bfb-84de-e053-2a95a90aae4610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-9993-1500363999315150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9993-15) 2019-09-280000-00-00NoNoCurrent
0363-9993-2100363999321225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9993-21) 2019-09-280000-00-00NoNoCurrent