FDA.reportPublic FDA data

good sense ibuprofen

Product NDC
68788-8590
11-digit product format
687888590
Labeler code
68788
Product ID
68788-8590_76da055e-e733-4b55-8e0f-7758957e8ed7
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA072096
Marketing category
ANDA
Marketing start
1989-09-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
good sense ibuprofen
Listing expiration
2027-12-31

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
68788-8590-1good sense ibuprofen100 in 1 BOTTLETABLET, FILM COATED1003
68788-8590-5good sense ibuprofen50 in 1 BOTTLETABLET, FILM COATED503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8590-1EA - Each68788-85908a6282ec-d0ff-43a8-8daf-f6441b54602212024-04-05
68788-8590-5EA - Each68788-8590ca50e7d8-6a29-41ef-8ee3-29e950dcfd9b12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8590GOOD SENSE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240310_f1a03b1f-2d87-43cc-b256-bd296ccd09f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNf1a03b1f-2d87-43cc-b256-bd296ccd09f23
310965ibuprofen 200 MG Oral TabletSCDf1a03b1f-2d87-43cc-b256-bd296ccd09f23
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYf1a03b1f-2d87-43cc-b256-bd296ccd09f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8590-168788859001100 TABLET, FILM COATED in 1 BOTTLE (68788-8590-1) 2024-02-21NoNoHistorical
68788-8590-56878885900550 TABLET, FILM COATED in 1 BOTTLE (68788-8590-5) 2024-02-21NoNoHistorical