FDA.reportPublic FDA data

Signature Care Ibuprofen

Product NDC
21130-818
11-digit product format
211300818
Labeler code
21130
Product ID
21130-818_bb90d586-be7a-4a3a-8c5c-a9916dce83d3
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safeway
Application
ANDA072096
Marketing category
ANDA
Marketing start
2015-09-14
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Signature Care Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-818-62Signature Care Ibuprofen24 in 1 BOTTLETABLET, FILM COATED244
21130-818-62Signature Care Ibuprofen1 in 1 CARTONTABLET, FILM COATED14
21130-818-71Signature Care Ibuprofen50 in 1 BOTTLETABLET, FILM COATED504
21130-818-71Signature Care Ibuprofen1 in 1 CARTONTABLET, FILM COATED14
21130-818-78Signature Care Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1004
21130-818-78Signature Care Ibuprofen1 in 1 CARTONTABLET, FILM COATED14
21130-818-90Signature Care Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
IBUPROFENACTIVE MOIETYWK2XYI10QMSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, COATED [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-818SIGNATURE CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [SAFEWAY]4Current NDC, Legacy NDC, 7 package rows20230930_93edca03-fdf1-453f-8efe-5f0b8eef41e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN93edca03-fdf1-453f-8efe-5f0b8eef41e44
310965ibuprofen 200 MG Oral TabletSCD93edca03-fdf1-453f-8efe-5f0b8eef41e44
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY93edca03-fdf1-453f-8efe-5f0b8eef41e44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-818-62211300818621 BOTTLE in 1 CARTON (21130-818-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-140000-00-00NoNoCurrent
21130-818-71211300818711 BOTTLE in 1 CARTON (21130-818-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-280000-00-00NoNoCurrent
21130-818-78211300818781 BOTTLE in 1 CARTON (21130-818-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-240000-00-00NoNoCurrent
21130-818-9021130081890500 TABLET, FILM COATED in 1 BOTTLE (21130-818-90) 2015-09-280000-00-00NoNoCurrent