FDA.reportPublic FDA data

IBUPROFEN

Product NDC
68071-5126
11-digit product format
680715126
Labeler code
68071
Product ID
68071-5126_1b549eac-763d-ab7a-e063-6294a90a72f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090796
Marketing category
ANDA
Marketing start
2015-12-30
Substance
IBUPROFEN
Active strength
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5126-92021-02-22C16284748780-1ba0f9c33-20fc-a910-e053-dadaa90a0b85IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS
68071-5126-92021-01-29C16284748780-1ba0f9c33-20fc-a910-e053-dadaa90a0b85IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5126-3IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED304
68071-5126-9IBUPROFEN90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5126IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240621_9973bfa2-693a-1165-e053-2995a90a4b1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN9973bfa2-693a-1165-e053-2995a90a4b1d4
197805ibuprofen 400 MG Oral TabletSCD9973bfa2-693a-1165-e053-2995a90a4b1d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5126-36807151260330 TABLET, FILM COATED in 1 BOTTLE (68071-5126-3) 2019-12-110000-00-00NoNoCurrent
68071-5126-96807151260990 TABLET, FILM COATED in 1 BOTTLE (68071-5126-9) 2019-12-110000-00-00NoNoCurrent