FDA.reportPublic FDA data

Topcare Ibuprofen

Product NDC
36800-647
11-digit product format
368000647
Labeler code
36800
Product ID
36800-647_02993180-71f3-4807-bc0d-45d10238c7a8
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA072096
Marketing category
ANDA
Marketing start
1988-11-15
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
Topcare 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
36800-647-62Topcare Ibuprofen1 in 1 CARTONTABLET, FILM COATED18
36800-647-62Topcare Ibuprofen24 in 1 BOTTLETABLET, FILM COATED248
36800-647-71Topcare Ibuprofen50 in 1 BOTTLETABLET, FILM COATED508
36800-647-71Topcare Ibuprofen1 in 1 CARTONTABLET, FILM COATED18
36800-647-76Topcare Ibuprofen1 in 1 CARTONTABLET, FILM COATED18
36800-647-76Topcare Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1208
36800-647-78Topcare Ibuprofen1 in 1 CARTONTABLET, FILM COATED18
36800-647-78Topcare Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1008
36800-647-90Topcare Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-647-62EA - Each36800-647eefde7d2-eef7-43ad-86aa-4777f63d4e2d12012-07-24
36800-647-71EA - Each36800-64745cfd9fc-9a42-4fdc-a59c-68284bf0ca6612012-07-24
36800-647-78EA - Each36800-647d0dd9bc6-85f4-4807-9e87-2a19dd64bd3f12012-07-24
36800-647-90EA - Each36800-647a333dd77-4386-4f67-b130-b386cad634fc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMTOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMTOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE IBUPROFEN (IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-647TOPCARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 9 package rows20230711_8be375b0-c729-49de-abc5-2e7d37144b89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN8be375b0-c729-49de-abc5-2e7d37144b898
310965ibuprofen 200 MG Oral TabletSCD8be375b0-c729-49de-abc5-2e7d37144b898
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY8be375b0-c729-49de-abc5-2e7d37144b898

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-647-62368000647621 BOTTLE in 1 CARTON (36800-647-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-04-280000-00-00NoNoCurrent
36800-647-71368000647711 BOTTLE in 1 CARTON (36800-647-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1988-11-150000-00-00NoNoCurrent
36800-647-76368000647761 BOTTLE in 1 CARTON (36800-647-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle1993-09-270000-00-00NoNoCurrent
36800-647-78368000647781 BOTTLE in 1 CARTON (36800-647-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1991-10-020000-00-00NoNoCurrent
36800-647-9036800064790500 TABLET, FILM COATED in 1 BOTTLE (36800-647-90) 2003-11-200000-00-00NoNoCurrent