FDA.reportPublic FDA data

Topcare Childrens Ibuprofen

Product NDC
36800-660
11-digit product format
368000660
Labeler code
36800
Product ID
36800-660_3fe40ea3-5aa7-4596-8630-93c790ef3fdb
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA074937
Marketing category
ANDA
Marketing start
2002-07-02
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topcare Childrens Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
36800-660-00Topcare Childrens Ibuprofen120 mL in 1 BOTTLESUSPENSION1208
36800-660-00Topcare Childrens Ibuprofen1 in 1 CARTONSUSPENSION18
36800-660-26Topcare Childrens Ibuprofen118 mL in 1 BOTTLESUSPENSION1188
36800-660-26Topcare Childrens Ibuprofen1 in 1 CARTONSUSPENSION18
36800-660-28Topcare Childrens Ibuprofen1 in 1 CARTONSUSPENSION18
36800-660-28Topcare Childrens Ibuprofen148 mL in 1 BOTTLESUSPENSION1488

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-660TOPCARE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 6 package rows20220624_45255d2f-c592-4750-abb5-21647d4fbd51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN45255d2f-c592-4750-abb5-21647d4fbd518
197803ibuprofen 20 MG/ML Oral SuspensionSCD45255d2f-c592-4750-abb5-21647d4fbd518
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY45255d2f-c592-4750-abb5-21647d4fbd518
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY45255d2f-c592-4750-abb5-21647d4fbd518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-660-00368000660001 BOTTLE in 1 CARTON (36800-660-00) / 120 mL in 1 BOTTLE1 bottle2020-01-010000-00-00NoNoCurrent
36800-660-26368000660261 BOTTLE in 1 CARTON (36800-660-26) > 118 mL in 1 BOTTLE1 bottle2002-07-022022-02-28NoNoCurrent
36800-660-28368000660281 BOTTLE in 1 CARTON (36800-660-28) > 148 mL in 1 BOTTLE1 bottle2013-03-122021-11-30NoNoCurrent