Ibuprofen

Product NDC
51655-851
11-digit product format
516550851
Labeler code
51655
Product ID
51655-851_26cd56b0-edbc-74f3-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA075682
Marketing category
ANDA
Marketing start
2015-11-04
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
51655-851-202026-01-29C16284748780-19d75b9d0-0766-f424-e053-dadaa90a57ceIbuprofen Tablets
51655-851-512026-01-29C16284748780-19d75b9d0-0766-f424-e053-dadaa90a57ceIbuprofen Tablets
51655-851-202024-02-19C16284748780-19d75b9d0-0766-f424-e053-dadaa90a57ceIbuprofen Tablets
51655-851-202020-01-31C16284748780-19d75b9d0-0766-f424-e053-dadaa90a57ceIbuprofen Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-851-20Ibuprofen20 in 1 BOTTLETABLET202
51655-851-51Ibuprofen40 in 1 BOTTLE, PLASTICTABLET402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-851IBUPROFEN TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Legacy NDC, 2 package rows20240220_26cd56b0-edbb-74f3-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN26cd56b0-edbb-74f3-e054-00144ff8d46c2
197807ibuprofen 800 MG Oral TabletSCD26cd56b0-edbb-74f3-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51655-851-205165508512020 in 1 BOTTLEHistorical
51655-851-515165508515140 in 1 BOTTLE, PLASTICHistorical