FDA.reportPublic FDA data

Ibuprofen

Product NDC
51138-039
11-digit product format
511380039
Labeler code
51138
Product ID
51138-039_7575a6c9-3e24-4de4-b675-77e3312cec2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Med Health Pharma, LLC
Application
ANDA078558
Marketing category
ANDA
Marketing start
2012-10-01
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
51138-039-152019-11-27C16284748780-19855d018-e47a-cd31-e053-dbdaa90ab51aIbuprofen Tablets, USP
51138-039-202019-11-27C16284748780-19855d018-e47a-cd31-e053-dbdaa90ab51aIbuprofen Tablets, USP
51138-039-212019-11-27C16284748780-19855d018-e47a-cd31-e053-dbdaa90ab51aIbuprofen Tablets, USP
51138-039-302019-11-27C16284748780-19855d018-e47a-cd31-e053-dbdaa90ab51aIbuprofen Tablets, USP
51138-039-402019-11-27C16284748780-19855d018-e47a-cd31-e053-dbdaa90ab51aIbuprofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51138-039-15Ibuprofen15 in 1 BOTTLETABLET, FILM COATED158
51138-039-20Ibuprofen20 in 1 BOTTLETABLET, FILM COATED208
51138-039-21Ibuprofen21 in 1 BOTTLETABLET, FILM COATED218
51138-039-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED308
51138-039-40Ibuprofen40 in 1 BOTTLETABLET, FILM COATED408

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51138-039-15EA - Each51138-039756ab760-3fef-4322-93d4-908faa65f8b312012-07-24
51138-039-20EA - Each51138-03922f597e2-74a3-4aa4-982b-85149ca4d22e12012-07-24
51138-039-21EA - Each51138-0391fafde56-3f66-41bb-af86-daa4abc8273712012-07-24
51138-039-30EA - Each51138-03923ebe86e-6b56-4db7-a50a-5255bb975a3012012-07-24
51138-039-40EA - Each51138-03947747637-5f2a-45eb-9c86-22b87a962c2812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [MED HEALTH PHARMA, LLC]8
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [MED HEALTH PHARMA, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51138-039IBUPROFEN TABLET, FILM COATED [MED HEALTH PHARMA, LLC]8Legacy NDC, 5 package rows20130219_912c536b-0d0c-4a9f-8778-c1534ceca658.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN912c536b-0d0c-4a9f-8778-c1534ceca6588
197807ibuprofen 800 MG Oral TabletSCD912c536b-0d0c-4a9f-8778-c1534ceca6588

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51138-039-155113800391515 in 1 BOTTLEHistorical
51138-039-205113800392020 in 1 BOTTLEHistorical
51138-039-215113800392121 in 1 BOTTLEHistorical
51138-039-305113800393030 in 1 BOTTLEHistorical
51138-039-405113800394040 in 1 BOTTLEHistorical