FDA.reportPublic FDA data

Ibuprofen

Product NDC
68071-2789
11-digit product format
680712789
Labeler code
68071
Product ID
68071-2789_e845d870-00c2-69d7-e053-2a95a90ad021
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA071268
Marketing category
ANDA
Marketing start
2021-10-21
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 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
2023-12-31
Current FDA listing
Historical FDA.report record

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
68071-2789-12025-01-30C16284748780-12cef2736-83c0-d83d-e063-dadaa90ab31fIbuprofen Tablet, USP
68071-2789-22025-01-30C16284748780-12cef2736-83c0-d83d-e063-dadaa90ab31fIbuprofen Tablet, USP
68071-2789-32025-01-30C16284748780-12cef2736-83c0-d83d-e063-dadaa90ab31fIbuprofen Tablet, USP
68071-2789-52025-01-30C16284748780-12cef2736-83c0-d83d-e063-dadaa90ab31fIbuprofen Tablet, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2789-1Ibuprofen21 in 1 BOTTLETABLET, FILM COATED214
68071-2789-2Ibuprofen20 in 1 BOTTLETABLET, FILM COATED204
68071-2789-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED304
68071-2789-5Ibuprofen15 in 1 BOTTLETABLET, FILM COATED154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2789IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC, 4 package rows20220911_e39e7296-99b8-3489-e053-2995a90a4e38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNe39e7296-99b8-3489-e053-2995a90a4e384
197807ibuprofen 800 MG Oral TabletSCDe39e7296-99b8-3489-e053-2995a90a4e384

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2789-16807127890121 TABLET, FILM COATED in 1 BOTTLE (68071-2789-1) 2022-07-120000-00-00NoNoCurrent
68071-2789-26807127890220 TABLET, FILM COATED in 1 BOTTLE (68071-2789-2) 2022-07-120000-00-00NoNoCurrent
68071-2789-36807127890330 TABLET, FILM COATED in 1 BOTTLE (68071-2789-3) 2022-07-120000-00-00NoNoCurrent
68071-2789-56807127890515 TABLET, FILM COATED in 1 BOTTLE (68071-2789-5) 2022-07-120000-00-00NoNoCurrent