FDA.reportPublic FDA data

Ibuprofen

Product NDC
36800-193
11-digit product format
368000193
Labeler code
36800
Product ID
36800-193_427b861c-4464-a4b3-e063-6394a90aefb5
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
ANDA078682
Marketing category
ANDA
Marketing start
2021-07-02
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
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
36800-193-11Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED16
36800-193-11Ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED206
36800-193-15Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED16
36800-193-15Ibuprofen40 in 1 BOTTLECAPSULE, LIQUID FILLED406
36800-193-78Ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED806
36800-193-83Ibuprofen300 in 1 BOTTLECAPSULE, LIQUID FILLED3006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-193IBUPROFEN CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]5Current NDC, Legacy NDC, 6 package rows20221229_c6297c23-3b27-c0c6-e053-2995a90a3e76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNc6297c23-3b27-c0c6-e053-2995a90a3e766
310964ibuprofen 200 MG Oral CapsuleSCDc6297c23-3b27-c0c6-e053-2995a90a3e766

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-193-11368000193111 BOTTLE in 1 CARTON (36800-193-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-07-020000-00-00NoNoCurrent
36800-193-15368000193151 BOTTLE in 1 CARTON (36800-193-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-12-290000-00-00NoNoCurrent
36800-193-783680001937880 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-193-78) 2021-07-020000-00-00NoNoCurrent
36800-193-8336800019383300 CAPSULE, LIQUID FILLED in 1 BOTTLE (36800-193-83) 2025-10-31NoNoCurrent