FDA.reportPublic FDA data

Ibuprofen

Product NDC
68071-3442
11-digit product format
680713442
Labeler code
68071
Product ID
68071-3442_29a54361-e109-20d7-e063-6294a90a117a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA213794
Marketing category
ANDA
Marketing start
2020-05-08
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3442-2Ibuprofen20 in 1 BOTTLETABLET203
68071-3442-3Ibuprofen30 in 1 BOTTLETABLET303
68071-3442-9Ibuprofen90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3442IBUPROFEN TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 3 package rows20241222_fe939219-d752-63a0-e053-6394a90a0ab2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNfe939219-d752-63a0-e053-6394a90a0ab23
197805ibuprofen 400 MG Oral TabletSCDfe939219-d752-63a0-e053-6394a90a0ab23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3442-26807134420220 TABLET in 1 BOTTLE (68071-3442-2) 20 tablet2024-12-19NoNoCurrent
68071-3442-36807134420330 TABLET in 1 BOTTLE (68071-3442-3) 30 tablet2023-06-20NoNoCurrent
68071-3442-96807134420990 TABLET in 1 BOTTLE (68071-3442-9) 90 tablet2023-06-20NoNoCurrent