FDA.reportPublic FDA data

Acetaminophen

Product NDC
50594-183
11-digit product format
505940183
Labeler code
50594
Product ID
50594-183_b7b4fa51-fe6d-0c2a-e053-2995a90af780
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
BIG LOTS STORES, INC.
Application
ANDA211544
Marketing category
ANDA
Marketing start
2020-03-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50594-183-242023-01-30C16284748780-1ab0e2407-2965-f274-e053-dbdaa90a64718 Hour Arthritis Pain Relief Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINIG ACETAMINOPHEN
50594-183-242020-12-30C16284748780-1ab0e2407-2965-f274-e053-dbdaa90a64718 Hour Arthritis Pain Relief Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINIG ACETAMINOPHEN
50594-183-242020-09-27C16284748780-1ab0e2407-2965-f274-e053-dbdaa90a64718 Hour Arthritis Pain Relief Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINIG ACETAMINOPHEN
50594-183-242020-09-25C16284748780-1ab0e2407-2965-f274-e053-dbdaa90a64718 Hour Arthritis Pain Relief Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINIG ACETAMINOPHEN
50594-183-242020-07-22C16284748780-1ab0e2407-2965-f274-e053-dbdaa90a64718 Hour Arthritis Pain Relief Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINIG ACETAMINOPHEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50594-183-24Acetaminophen24 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50594-183ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [BIG LOTS STORES, INC.]2Legacy NDC, 1 package rows20201231_9caa35ae-8a3e-b51a-e053-2995a90a4475.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN9caa35ae-8a3e-b51a-e053-2995a90a44752
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD9caa35ae-8a3e-b51a-e053-2995a90a44752
11483998 HR APAP 650 MG Extended Release Oral TabletSY9caa35ae-8a3e-b51a-e053-2995a90a44752
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY9caa35ae-8a3e-b51a-e053-2995a90a44752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50594-183-245059401832424 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50594-183-24) 2020-03-310000-00-00NoNoCurrent