FDA.reportPublic FDA data

Acetaminophen

Product NDC
0363-0340
11-digit product format
003630340
Labeler code
0363
Product ID
0363-0340_1bc5ce72-38f4-43f7-99cc-2b8b4725e15b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA078569
Marketing category
ANDA
Marketing start
2016-05-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0340-08Acetaminophen80 in 1 BOTTLETABLET, EXTENDED RELEASE804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0340-08EA - Each0363-0340d0be207a-dbd3-4ae2-a6f3-8be74791c47e12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
GELATININACTIVE INGREDIENT2G86QN327LACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0340ACETAMINOPHEN TABLET, EXTENDED RELEASE [WALGREEN COMPANY]4Current NDC, Legacy NDC, 1 package rows20180817_a1cec332-5802-4684-8b7f-6cb98da40e8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNa1cec332-5802-4684-8b7f-6cb98da40e8b4
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDa1cec332-5802-4684-8b7f-6cb98da40e8b4
11483998 HR APAP 650 MG Extended Release Oral TabletSYa1cec332-5802-4684-8b7f-6cb98da40e8b4
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYa1cec332-5802-4684-8b7f-6cb98da40e8b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0340-080036303400880 TABLET, EXTENDED RELEASE in 1 BOTTLE (0363-0340-08) 2016-05-010000-00-00NoNoCurrent