FDA.reportPublic FDA data

TopCare Ibuprofen

Product NDC
36800-604
11-digit product format
368000604
Labeler code
36800
Product ID
36800-604_7b44c9b1-8c1d-4234-922c-9ffff0202bc5
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
1988-02-15
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
36800-604-62TopCare Ibuprofen24 in 1 BOTTLETABLET, FILM COATED2410
36800-604-62TopCare Ibuprofen1 in 1 CARTONTABLET, FILM COATED110
36800-604-71TopCare Ibuprofen1 in 1 CARTONTABLET, FILM COATED110
36800-604-71TopCare Ibuprofen50 in 1 BOTTLETABLET, FILM COATED5010
36800-604-76TopCare Ibuprofen1 in 1 CARTONTABLET, FILM COATED110
36800-604-76TopCare Ibuprofen120 in 1 BOTTLETABLET, FILM COATED12010
36800-604-78TopCare Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10010
36800-604-78TopCare Ibuprofen1 in 1 CARTONTABLET, FILM COATED110
36800-604-82TopCare Ibuprofen2 in 1 CARTONTABLET, FILM COATED210
36800-604-82TopCare Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10010
36800-604-85TopCare Ibuprofen250 in 1 BOTTLETABLET, FILM COATED25010
36800-604-85TopCare Ibuprofen1 in 1 CARTONTABLET, FILM COATED110
36800-604-90TopCare Ibuprofen500 in 1 BOTTLETABLET, FILM COATED50010
36800-604-93TopCare Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-604TOPCARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]10Current NDC, Legacy NDC, 14 package rows20250418_66097f19-227c-4f9c-a7f3-ab8476e1bb6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN66097f19-227c-4f9c-a7f3-ab8476e1bb6e10
310965ibuprofen 200 MG Oral TabletSCD66097f19-227c-4f9c-a7f3-ab8476e1bb6e10
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY66097f19-227c-4f9c-a7f3-ab8476e1bb6e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-604-62368000604621 BOTTLE in 1 CARTON (36800-604-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle1991-06-150000-00-00NoNoCurrent
36800-604-71368000604711 BOTTLE in 1 CARTON (36800-604-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1988-02-150000-00-00NoNoCurrent
36800-604-76368000604761 BOTTLE in 1 CARTON (36800-604-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle1993-09-270000-00-00NoNoCurrent
36800-604-78368000604781 BOTTLE in 1 CARTON (36800-604-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1988-03-150000-00-00NoNoCurrent
36800-604-82368000604822 BOTTLE in 1 CARTON (36800-604-82) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle1988-02-150000-00-00NoNoCurrent
36800-604-85368000604851 BOTTLE in 1 CARTON (36800-604-85) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle1991-07-300000-00-00NoNoCurrent
36800-604-9036800060490500 TABLET, FILM COATED in 1 BOTTLE (36800-604-90) 1993-07-290000-00-00NoNoCurrent
36800-604-93368000604931000 in 1 BOTTLEHistorical