Acetaminophen

Product NDC
0363-9604
11-digit product format
003639604
Labeler code
0363
Product ID
0363-9604_e6c2e68f-9711-4b57-b72b-ece33e19edc6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA207229
Marketing category
ANDA
Marketing start
2021-07-07
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9604-07003639604071 BOTTLE in 1 CARTON (0363-9604-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-07-07NoNoHistorical
0363-9604-35003639604351 BOTTLE in 1 CARTON (0363-9604-35) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-07-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Acetaminophen - WALGREEN CO. | Aurohealth LLC | Aurobindo Pharma LimitedWALGREEN CO. | Aurohealth LLC | Aurobindo Pharma Limited2024-05-06Human OTC Drug Label7