FDA.reportPublic FDA data

Ibuprofen

Product NDC
51655-048
11-digit product format
516550048
Labeler code
51655
Product ID
51655-048_46ddbacb-b89a-1715-e063-6394a90a3c49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA091625
Marketing category
ANDA
Marketing start
2020-05-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

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
51655-048-262023-02-06C16284748780-1f386c649-9e5a-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
51655-048-262023-01-30C16284748780-1f386c649-9e5a-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-048-26Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905
51655-048-52Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-048IBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240704_ab074ae8-5696-5327-e053-2a95a90a7ce3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNab074ae8-5696-5327-e053-2a95a90a7ce35
197805ibuprofen 400 MG Oral TabletSCDab074ae8-5696-5327-e053-2a95a90a7ce35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-048-265165500482690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-048-26) 2020-05-200000-00-00NoNoCurrent
51655-048-525165500485230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-048-52) 2022-10-14NoNoHistorical