FDA.reportPublic FDA data

Ibuprofen

Product NDC
68071-2947
11-digit product format
680712947
Labeler code
68071
Product ID
68071-2947_42681df8-212b-1e46-e063-6394a90a9f8c
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
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2947-12025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-12025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-22025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-22025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-32025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-32025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-52025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-52025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-62025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-62025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-92025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-92025-10-31C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-12025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-12025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-22025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-22025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-32025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-32025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-52025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-52025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-62025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-62025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-92025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only
68071-2947-92025-01-30C16284748780-12cef2736-9957-d83d-e063-dadaa90ab31fIbuprofen Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2947-1Ibuprofen21 in 1 BOTTLETABLET216
68071-2947-2Ibuprofen20 in 1 BOTTLETABLET206
68071-2947-3Ibuprofen30 in 1 BOTTLETABLET306
68071-2947-4Ibuprofen40 in 1 BOTTLETABLET406
68071-2947-5Ibuprofen50 in 1 BOTTLETABLET506
68071-2947-6Ibuprofen60 in 1 BOTTLETABLET606
68071-2947-9Ibuprofen90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2947IBUPROFEN TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, 7 package rows20230608_f60445d3-807e-0bbf-e053-2995a90a1299.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNf60445d3-807e-0bbf-e053-2995a90a12996
197806ibuprofen 600 MG Oral TabletSCDf60445d3-807e-0bbf-e053-2995a90a12996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2947-16807129470121 TABLET in 1 BOTTLE (68071-2947-1) 21 tablet2023-03-03NoNoCurrent
68071-2947-26807129470220 TABLET in 1 BOTTLE (68071-2947-2) 20 tablet2023-03-03NoNoCurrent
68071-2947-36807129470330 TABLET in 1 BOTTLE (68071-2947-3) 30 tablet2023-03-03NoNoCurrent
68071-2947-46807129470440 TABLET in 1 BOTTLE (68071-2947-4) 40 tablet2025-10-30NoNoCurrent
68071-2947-56807129470550 TABLET in 1 BOTTLE (68071-2947-5) 50 tablet2023-03-03NoNoCurrent
68071-2947-66807129470660 TABLET in 1 BOTTLE (68071-2947-6) 60 tablet2023-03-03NoNoCurrent
68071-2947-96807129470990 TABLET in 1 BOTTLE (68071-2947-9) 90 tablet2023-03-03NoNoCurrent