Ibuprofen

Product NDC
59779-438
11-digit product format
597790438
Labeler code
59779
Product ID
59779-438_4bd1345d-d116-426e-825f-bbf29381746a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA075139
Marketing category
ANDA
Marketing start
1999-03-01
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
Ibuprofen
Brand name suffix
Dye Free
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
59779-438-12IbuprofenDye Free100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10017
59779-438-12IbuprofenDye Free1 in 1 CARTONTABLET, FILM COATED117
59779-438-13IbuprofenDye Free1 in 1 CARTONTABLET, FILM COATED117
59779-438-13IbuprofenDye Free250 in 1 BOTTLETABLET, FILM COATED25017
59779-438-15IbuprofenDye Free50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-438IBUPROFEN DYE FREE (IBUPROFEN) TABLET, FILM COATED [CVS PHARMACY]16Current NDC, Legacy NDC, 5 package rows20250406_00653b7c-7099-487e-9a01-e89781c21323.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN00653b7c-7099-487e-9a01-e89781c2132317
310965ibuprofen 200 MG Oral TabletSCD00653b7c-7099-487e-9a01-e89781c2132317
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY00653b7c-7099-487e-9a01-e89781c2132317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59779-438-12597790438121 BOTTLE, PLASTIC in 1 CARTON (59779-438-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-010000-00-00NoNoCurrent
59779-438-13597790438131 in 1 CARTONHistorical
59779-438-155977904381550 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59779-438-15) 1999-03-010000-00-00NoNoCurrent