FDA.reportPublic FDA data

Ibuprofen

Product NDC
69848-012
11-digit product format
698480012
Labeler code
69848
Product ID
69848-012_468e7be2-fca0-7715-e063-6394a90abc85
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Granules USA, Inc.
Application
ANDA079174
Marketing category
ANDA
Marketing start
2019-07-01
Substance
IBUPROFEN
Active strength
200 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
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
69848-012-102020-10-09C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
69848-012-242020-10-09C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
69848-012-252020-10-09C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
69848-012-102020-09-27C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
69848-012-242020-09-27C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
69848-012-252020-09-27C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
69848-012-102020-09-25C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
69848-012-242020-09-25C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
69848-012-252020-09-25C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
69848-012-102020-07-22C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
69848-012-242020-07-22C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
69848-012-252020-07-22C16284748780-1ab0e2407-340e-f274-e053-dbdaa90a6471SEE NEW WARNINGS Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69848-012-10Ibuprofen100 in 1 BOTTLETABLET1006
69848-012-24Ibuprofen24 in 1 BOTTLETABLET246
69848-012-25Ibuprofen250 in 1 BOTTLETABLET2506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69848-012IBUPROFEN TABLET [GRANULES USA, INC.]5Current NDC, Legacy NDC, 3 package rows20241228_8cb595d2-b7c2-687d-e053-2a95a90a5720.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN8cb595d2-b7c2-687d-e053-2a95a90a57206
310965ibuprofen 200 MG Oral TabletSCD8cb595d2-b7c2-687d-e053-2a95a90a57206
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY8cb595d2-b7c2-687d-e053-2a95a90a57206

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69848-012-1069848001210100 TABLET in 1 BOTTLE (69848-012-10) 100 tablet2019-07-010000-00-00NoNoCurrent
69848-012-246984800122424 TABLET in 1 BOTTLE (69848-012-24) 24 tablet2019-07-010000-00-00NoNoCurrent
69848-012-2569848001225250 TABLET in 1 BOTTLE (69848-012-25) 250 tablet2019-07-010000-00-00NoNoCurrent