FDA.reportPublic FDA data

good sense ibuprofen

Product NDC
0113-0647
11-digit product format
001130647
Labeler code
0113
Product ID
0113-0647_1937bbd6-c841-4ee5-82b4-615b46abaf48
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA072096
Marketing category
ANDA
Marketing start
1991-02-15
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
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
0113-0647-62good sense ibuprofen24 in 1 BOTTLETABLET, FILM COATED246
0113-0647-62good sense ibuprofen1 in 1 CARTONTABLET, FILM COATED16
0113-0647-71good sense ibuprofen1 in 1 CARTONTABLET, FILM COATED16
0113-0647-71good sense ibuprofen50 in 1 BOTTLETABLET, FILM COATED506
0113-0647-76good sense ibuprofen120 in 1 BOTTLETABLET, FILM COATED1206
0113-0647-76good sense ibuprofen1 in 1 CARTONTABLET, FILM COATED16
0113-0647-78good sense ibuprofen100 in 1 BOTTLETABLET, FILM COATED1006
0113-0647-78good sense ibuprofen1 in 1 CARTONTABLET, FILM COATED16
0113-0647-82good sense ibuprofen2 in 1 CARTONTABLET, FILM COATED26
0113-0647-82good sense ibuprofen100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0647-62EA - Each0113-064734e3944d-6c01-46fc-9d20-877f8397341d12012-07-24
0113-0647-71EA - Each0113-0647c9b191dd-cc60-49e4-b433-f2d87327559612012-07-24
0113-0647-76EA - Each0113-06470d5df761-015b-4a1e-beaa-71244cd5b55312018-03-08
0113-0647-78EA - Each0113-0647924bde45-1f48-4b51-a90f-05cd9203a41c12012-07-24
0113-0647-82EA - Each0113-0647b4519d42-a1cb-4766-9bb0-ae4d5ce456f012024-02-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
IBUPROFENACTIVE MOIETYWK2XYI10QMGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, COATED [L PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0647GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L. PERRIGO COMPANY]6Current NDC, Legacy NDC, 10 package rows20230718_9164f7e8-81a0-4b71-a2b3-111b2a7541bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN9164f7e8-81a0-4b71-a2b3-111b2a7541bb6
310965ibuprofen 200 MG Oral TabletSCD9164f7e8-81a0-4b71-a2b3-111b2a7541bb6
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY9164f7e8-81a0-4b71-a2b3-111b2a7541bb6
310965ibuprofen 200 MG Oral TabletPSN57af05fc-30b9-4487-9a37-fb35dac4acf72
310965ibuprofen 200 MG Oral TabletSCD57af05fc-30b9-4487-9a37-fb35dac4acf72
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY57af05fc-30b9-4487-9a37-fb35dac4acf72
310965ibuprofen 200 MG Oral TabletPSNc447fc6b-e9ef-447a-9609-5f893e18dfa71
310965ibuprofen 200 MG Oral TabletSCDc447fc6b-e9ef-447a-9609-5f893e18dfa71
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYc447fc6b-e9ef-447a-9609-5f893e18dfa71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0647-62001130647621 BOTTLE in 1 CARTON (0113-0647-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle1995-12-080000-00-00NoNoCurrent
0113-0647-71001130647711 BOTTLE in 1 CARTON (0113-0647-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1991-07-310000-00-00NoNoCurrent
0113-0647-76001130647761 BOTTLE in 1 CARTON (0113-0647-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle1995-05-030000-00-00NoNoCurrent
0113-0647-78001130647781 BOTTLE in 1 CARTON (0113-0647-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1991-02-150000-00-00NoNoCurrent
0113-0647-82001130647822 BOTTLE in 1 CARTON (0113-0647-82) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2012-09-060000-00-00NoNoCurrent