Signature Care Ibuprofen

Product NDC
21130-585
11-digit product format
211300585
Labeler code
21130
Product ID
21130-585_e7c23152-612b-4733-bb76-09a6929eddba
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safeway
Application
ANDA072096
Marketing category
ANDA
Marketing start
2015-08-12
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
IBUPROFENACTIVE MOIETYWK2XYI10QMSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-585SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]7Legacy NDC20200130_bc258e91-2750-4c4e-bcbf-6c96f0d41f54.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-585-5921130058559750 TABLET, FILM COATED in 1 BOTTLE (21130-585-59) 2015-11-130000-00-00NoNoCurrent
21130-585-62211300585621 BOTTLE in 1 CARTON (21130-585-62) > 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-040000-00-00NoNoCurrent
21130-585-76211300585761 BOTTLE in 1 CARTON (21130-585-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-06-270000-00-00NoNoCurrent
21130-585-78211300585781 BOTTLE in 1 CARTON (21130-585-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-040000-00-00NoNoCurrent
21130-585-8521130058585250 TABLET, FILM COATED in 1 BOTTLE (21130-585-85) 2015-09-010000-00-00NoNoCurrent
21130-585-9021130058590500 TABLET, FILM COATED in 1 BOTTLE (21130-585-90) 2015-08-120000-00-00NoNoCurrent
21130-585-93211300585931000 TABLET, FILM COATED in 1 BOTTLE (21130-585-93) 2018-07-110000-00-00NoNoCurrent