FDA.reportPublic FDA data

Ibuprofen

Product NDC
68071-3778
11-digit product format
680713778
Labeler code
68071
Product ID
68071-3778_35acc4bb-0101-8c7c-e063-6394a90a4ac3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA202413
Marketing category
ANDA
Marketing start
2024-05-23
Substance
IBUPROFEN
Active strength
600 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
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197806

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
68071-3778-2Ibuprofen20 in 1 BOTTLETABLET, FILM COATED203
68071-3778-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED303
68071-3778-5Ibuprofen50 in 1 BOTTLETABLET, FILM COATED503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3778IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]3Current NDC, 3 package rows20250523_2c3f8149-9b77-54cd-e063-6394a90a847e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN2c3f8149-9b77-54cd-e063-6394a90a847e3
197806ibuprofen 600 MG Oral TabletSCD2c3f8149-9b77-54cd-e063-6394a90a847e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3778-26807137780220 TABLET, FILM COATED in 1 BOTTLE (68071-3778-2) 2025-01-29NoNoHistorical
68071-3778-36807137780330 TABLET, FILM COATED in 1 BOTTLE (68071-3778-3) 2025-01-21NoNoHistorical
68071-3778-56807137780550 TABLET, FILM COATED in 1 BOTTLE (68071-3778-5) 2025-05-21NoNoHistorical