FDA.reportPublic FDA data

topcare ibuprofen

Product NDC
36800-897
11-digit product format
368000897
Labeler code
36800
Product ID
36800-897_425d20bf-3122-45aa-b83d-2a68ce57ef9e
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA074937
Marketing category
ANDA
Marketing start
1998-12-31
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-897-26topcare ibuprofen1 in 1 CARTONSUSPENSION19
36800-897-26topcare ibuprofen120 mL in 1 BOTTLESUSPENSION1209
36800-897-28topcare ibuprofen1 in 1 CARTONSUSPENSION19
36800-897-28topcare ibuprofen150 mL in 1 BOTTLESUSPENSION1509
36800-897-34topcare ibuprofen120 mL in 1 BOTTLESUSPENSION1209
36800-897-34topcare ibuprofen2 in 1 CARTONSUSPENSION29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-897-26ML - Milliliter36800-8971a1b5c4b-7b93-47b3-ae89-c52471d569f112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMTOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
IBUPROFENACTIVE MOIETYWK2XYI10QMTOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
SORBITOLINACTIVE INGREDIENT506T60A25RTOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-897TOPCARE IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]9Legacy NDC, 6 package rows20220819_2a8ba703-587f-4717-a9d5-ee142e36a4d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN2a8ba703-587f-4717-a9d5-ee142e36a4d99
197803ibuprofen 20 MG/ML Oral SuspensionSCD2a8ba703-587f-4717-a9d5-ee142e36a4d99
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY2a8ba703-587f-4717-a9d5-ee142e36a4d99
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY2a8ba703-587f-4717-a9d5-ee142e36a4d99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-897-26368000897261 BOTTLE in 1 CARTON (36800-897-26) > 120 mL in 1 BOTTLE1 bottle1998-12-310000-00-00NoNoCurrent
36800-897-28368000897281 BOTTLE in 1 CARTON (36800-897-28) > 150 mL in 1 BOTTLE1 bottle2013-03-080000-00-00NoNoCurrent
36800-897-34368000897342 BOTTLE in 1 CARTON (36800-897-34) > 120 mL in 1 BOTTLE2 bottle2017-10-110000-00-00NoNoCurrent