FDA.reportPublic FDA data

Ibuprofen

Product NDC
51655-474
11-digit product format
516550474
Labeler code
51655
Product ID
51655-474_490f163b-b179-d74b-e063-6394a90ad438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090796
Marketing category
ANDA
Marketing start
2020-11-13
Substance
IBUPROFEN
Active strength
600 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
IBUPROFEN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197806

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-474-20Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED204
51655-474-25Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
51655-474-26Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
51655-474-51Ibuprofen40 in 1 BOTTLE, PLASTICTABLET, FILM COATED404
51655-474-52Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-474IBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 5 package rows20250101_dac07d8f-6b6f-20ab-e053-2a95a90af3ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNdac07d8f-6b6f-20ab-e053-2a95a90af3ba4
197806ibuprofen 600 MG Oral TabletSCDdac07d8f-6b6f-20ab-e053-2a95a90af3ba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-474-205165504742020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-474-20) 2020-11-19NoNoCurrent
51655-474-255165504742560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-474-25) 2020-11-13NoNoCurrent
51655-474-265165504742690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-474-26) 2022-06-21NoNoCurrent
51655-474-515165504745140 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-474-51) 2021-02-08NoNoCurrent
51655-474-525165504745230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-474-52) 2021-01-14NoNoCurrent