Acetaminophen

Product NDC
69842-297
11-digit product format
698420297
Labeler code
69842
Product ID
69842-297_46544b42-ae4b-e5e9-e063-6294a90ab3ef
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
CVS PHARMACY iNC
Application
ANDA211544
Marketing category
ANDA
Marketing start
2020-01-30
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
69842-297-102023-03-02C16284748780-1ab0e2407-35bd-f274-e053-dbdaa90a64718HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-202023-03-02C16284748780-1ab0e2407-35bd-f274-e053-dbdaa90a64718HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-102023-01-30C16284748780-1ab0e2407-35bd-f274-e053-dbdaa90a64718HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-202023-01-30C16284748780-1ab0e2407-35bd-f274-e053-dbdaa90a64718HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-202020-12-29C16284748780-1ab0e2407-35bd-f274-e053-dbdaa90a64718HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-202020-09-27C16284748780-1ab0e2407-35bd-f274-e053-dbdaa90a64718HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-202020-09-25C16284748780-1ab0e2407-35bd-f274-e053-dbdaa90a64718HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin
69842-297-202020-07-22C16284748780-1ab0e2407-35bd-f274-e053-dbdaa90a64718HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever / Fever Reducer For upto 8 hour relief of minor muscle aches & pain Contains no aspirin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-297-10Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008
69842-297-20Acetaminophen200 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE2008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-297ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY INC]6Current NDC, Legacy NDC, 2 package rows20241120_90cea23f-5ddb-7a36-e053-2a95a90a20cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN90cea23f-5ddb-7a36-e053-2a95a90a20cf8
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD90cea23f-5ddb-7a36-e053-2a95a90a20cf8
11483998 HR APAP 650 MG Extended Release Oral TabletSY90cea23f-5ddb-7a36-e053-2a95a90a20cf8
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY90cea23f-5ddb-7a36-e053-2a95a90a20cf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-297-1069842029710100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69842-297-10) 2021-02-010000-00-00NoNoCurrent
69842-297-2069842029720200 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69842-297-20) 2020-01-300000-00-00NoNoCurrent