FDA.reportPublic FDA data

Ibuprofen

Product NDC
68071-4968
11-digit product format
680714968
Labeler code
68071
Product ID
68071-4968_47ad6d70-f32d-e896-e063-6294a90a0bbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078329
Marketing category
ANDA
Marketing start
2014-04-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4968-32023-12-26C16284748780-1ba0f9c33-1dc6-a910-e053-dadaa90a0b85Ibuprofen tablets Strides Shasun Limited
68071-4968-32023-01-30C16284748780-1ba0f9c33-1dc6-a910-e053-dadaa90a0b85Ibuprofen tablets Strides Shasun Limited
68071-4968-32021-02-18C16284748780-1ba0f9c33-1dc6-a910-e053-dadaa90a0b85Ibuprofen tablets Strides Shasun Limited
68071-4968-32021-01-29C16284748780-1ba0f9c33-1dc6-a910-e053-dadaa90a0b85Ibuprofen tablets Strides Shasun Limited

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4968-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED307
68071-4968-4Ibuprofen40 in 1 BOTTLETABLET, FILM COATED407
68071-4968-5Ibuprofen50 in 1 BOTTLETABLET, FILM COATED507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4968IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 3 package rows20240911_8dba0ed8-feef-23a5-e053-2995a90aaff8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN8dba0ed8-feef-23a5-e053-2995a90aaff87
197806ibuprofen 600 MG Oral TabletSCD8dba0ed8-feef-23a5-e053-2995a90aaff87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4968-36807149680330 TABLET, FILM COATED in 1 BOTTLE (68071-4968-3) 2019-07-150000-00-00NoNoCurrent
68071-4968-46807149680440 TABLET, FILM COATED in 1 BOTTLE (68071-4968-4) 2019-07-15NoNoHistorical
68071-4968-56807149680550 TABLET, FILM COATED in 1 BOTTLE (68071-4968-5) 2024-09-10NoNoHistorical