FDA.reportPublic FDA data

good sense ibuprofen

Product NDC
0113-0298
11-digit product format
001130298
Labeler code
0113
Product ID
0113-0298_2090f989-55fa-43de-b9e9-b83670605641
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA203599
Marketing category
ANDA
Marketing start
2018-02-20
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
good sense 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
0113-0298-06good sense ibuprofen160 in 1 BOTTLECAPSULE, LIQUID FILLED1607
0113-0298-06good sense ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED17
0113-0298-27good sense ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED807
0113-0298-27good sense ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED17
0113-0298-58good sense ibuprofen40 in 1 BOTTLECAPSULE, LIQUID FILLED407
0113-0298-58good sense ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED17
0113-0298-60good sense ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED17
0113-0298-60good sense ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0298-06EA - Each0113-02986e97c3f5-df50-4d57-bd16-42204d0b7a0a12024-02-14
0113-0298-58EA - Each0113-0298f0e86bb8-4951-4864-ba88-6d625ce6890812022-03-09
0113-0298-60EA - Each0113-0298975c44dd-c0cf-4d64-b2ed-89b24a9442bc12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0298GOOD SENSE IBUPROFEN (IBUPROFEN) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]7Current NDC, Legacy NDC, 8 package rows20250327_3b78c004-e4fe-449c-86e9-52e8ccf12785.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN3b78c004-e4fe-449c-86e9-52e8ccf127857
310964ibuprofen 200 MG Oral CapsuleSCD3b78c004-e4fe-449c-86e9-52e8ccf127857

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0298-06001130298061 BOTTLE in 1 CARTON (0113-0298-06) > 160 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-11-050000-00-00NoNoCurrent
0113-0298-27001130298271 BOTTLE in 1 CARTON (0113-0298-27) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-02-240000-00-00NoNoCurrent
0113-0298-58001130298581 BOTTLE in 1 CARTON (0113-0298-58) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2018-02-200000-00-00NoNoCurrent
0113-0298-60001130298601 BOTTLE in 1 CARTON (0113-0298-60) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2018-05-070000-00-00NoNoCurrent