FDA.reportPublic FDA data

Topcare ibuprofen

Product NDC
36800-517
11-digit product format
368000517
Labeler code
36800
Product ID
36800-517_ed34bfbd-1e0c-4acb-b48e-e63c75423693
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA077349
Marketing category
ANDA
Marketing start
2006-04-28
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
36800-517-71Topcare ibuprofen50 in 1 BOTTLETABLET, FILM COATED507
36800-517-71Topcare ibuprofen1 in 1 CARTONTABLET, FILM COATED17
36800-517-78Topcare ibuprofen1 in 1 CARTONTABLET, FILM COATED17
36800-517-78Topcare ibuprofen100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-517-71EA - Each36800-517add5108f-5850-47fe-8f96-a863fa5daa3712012-07-24
36800-517-78EA - Each36800-517ffa3e8b9-17c2-4ea1-8d54-e8759d96f0d312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMTOPCARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMTOPCARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-517TOPCARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]6Current NDC, Legacy NDC, 4 package rows20230908_479a0c97-dbd9-47ad-9910-9dd4edf5136f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN479a0c97-dbd9-47ad-9910-9dd4edf5136f7
310965ibuprofen 200 MG Oral TabletSCD479a0c97-dbd9-47ad-9910-9dd4edf5136f7
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY479a0c97-dbd9-47ad-9910-9dd4edf5136f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-517-71368000517711 BOTTLE in 1 CARTON (36800-517-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-04-280000-00-00NoNoCurrent
36800-517-78368000517781 BOTTLE in 1 CARTON (36800-517-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-06-190000-00-00NoNoCurrent