FDA.reportPublic FDA data

Good Sense Ibuprofen

Product NDC
0113-1212
11-digit product format
001131212
Labeler code
0113
Product ID
0113-1212_772fd900-3833-4bf9-bbb3-e85d47e90998
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
2020-10-19
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
0113-1212-09Good Sense Ibuprofen50 in 1 CARTONTABLET, FILM COATED503
0113-1212-54Good Sense Ibuprofen2 in 1 POUCHTABLET, FILM COATED23
0113-1212-85Good Sense Ibuprofen250 in 1 BOTTLETABLET, FILM COATED2503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-1212-09EA - Each0113-1212ada9ab55-59d8-49ee-a4e0-9a424afff05812023-01-09
0113-1212-85EA - Each0113-121242ed3117-52a4-4764-9aa7-af38b0974cd112022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1212GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 3 package rows20230826_f9af5970-18ca-46d5-8d6c-c0fec22a66d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNf9af5970-18ca-46d5-8d6c-c0fec22a66d53
310965ibuprofen 200 MG Oral TabletSCDf9af5970-18ca-46d5-8d6c-c0fec22a66d53
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYf9af5970-18ca-46d5-8d6c-c0fec22a66d53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-1212-090011312120950 POUCH in 1 CARTON (0113-1212-09) / 2 TABLET, FILM COATED in 1 POUCH (0113-1212-54) 50 pouch2021-02-120000-00-00NoNoCurrent
0113-1212-54001131212542 in 1 POUCHHistorical
0113-1212-8500113121285250 TABLET, FILM COATED in 1 BOTTLE (0113-1212-85) 2020-10-190000-00-00NoNoCurrent