FDA.reportPublic FDA data

Ibuprofen

Product NDC
11788-004
11-digit product format
117880004
Labeler code
11788
Product ID
11788-004_76b47c18-02e3-524e-e053-2a91aa0adaec
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA206990
Marketing category
ANDA
Marketing start
2019-03-01
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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
11788-004-002024-01-30C16284748780-11030e365-0e9c-111a-e063-dadaa90a10e2IBUPROFEN ROUND TABLETS, USP 200mg
11788-004-072024-01-30C16284748780-11030e365-293f-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 200 mg
11788-004-102024-01-30C16284748780-11030e365-293f-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11788-004-07Ibuprofen1 in 1 CARTONTABLET, FILM COATED12
11788-004-07Ibuprofen24 in 1 BOTTLETABLET, FILM COATED242
11788-004-10Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10002
11788-004-00Ibuprofen50864 in 1 CARTONTABLET, FILM COATED508641

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11788-004IBUPROFEN TABLET, FILM COATED [AIPING PHARMACEUTICAL, INC.]2Legacy NDC, 3 package rows20190301_764ff65b-e6de-62e5-e053-2991aa0a94e5.zip
11788-004IBUPROFEN TABLET, FILM COATED [AIPING PHARMACEUTICAL, INC.]1Legacy NDC, 1 package rows20190301_76b47c18-02e2-524e-e053-2a91aa0adaec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN764ff65b-e6de-62e5-e053-2991aa0a94e52
310965ibuprofen 200 MG Oral TabletSCD764ff65b-e6de-62e5-e053-2991aa0a94e52
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY764ff65b-e6de-62e5-e053-2991aa0a94e52
310965ibuprofen 200 MG Oral TabletPSN76b47c18-02e2-524e-e053-2a91aa0adaec1
310965ibuprofen 200 MG Oral TabletSCD76b47c18-02e2-524e-e053-2a91aa0adaec1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY76b47c18-02e2-524e-e053-2a91aa0adaec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11788-004-001178800040050864 TABLET, FILM COATED in 1 CARTON (11788-004-00) 2019-03-010000-00-00NoNoCurrent
11788-004-07117880004071 BOTTLE in 1 CARTON (11788-004-07) > 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-03-010000-00-00NoNoCurrent
11788-004-10117880004101000 TABLET, FILM COATED in 1 BOTTLE (11788-004-10) 2019-03-010000-00-00NoNoCurrent