FDA.reportPublic FDA data

Ibuprofen

Product NDC
50090-2548
11-digit product format
500902548
Labeler code
50090
Product ID
50090-2548_f0c4785a-b0fb-439c-b323-1fa74881a338
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
Substance
IBUPROFEN
Active strength
800 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
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805, 197806, 197807

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
50090-2548-02023-02-07C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-12023-02-07C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-22023-02-07C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-32023-02-07C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-42023-02-07C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-52023-02-07C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-72023-02-07C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-82023-02-07C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-92023-02-07C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-02023-01-30C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-12023-01-30C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-22023-01-30C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-32023-01-30C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-42023-01-30C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-52023-01-30C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-72023-01-30C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-82023-01-30C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2548-92023-01-30C16284748780-1f386c649-e254-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2548-0Ibuprofen10 in 1 BOTTLETABLET, FILM COATED1055
50090-2548-1Ibuprofen15 in 1 BOTTLETABLET, FILM COATED1555
50090-2548-2Ibuprofen30 in 1 BOTTLETABLET, FILM COATED3055
50090-2548-3Ibuprofen45 in 1 BOTTLETABLET, FILM COATED4555
50090-2548-4Ibuprofen60 in 1 BOTTLETABLET, FILM COATED6055
50090-2548-5Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10055
50090-2548-7Ibuprofen21 in 1 BOTTLETABLET, FILM COATED2155
50090-2548-8Ibuprofen12 in 1 BOTTLETABLET, FILM COATED1255
50090-2548-9Ibuprofen40 in 1 BOTTLETABLET, FILM COATED4055

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2548-0EA - Each50090-2548e435607f-4032-4e20-90d3-9fc3b0c3a26712019-03-12
50090-2548-1EA - Each50090-2548fa5111fe-da49-4b28-a85e-5a2e20d7e9aa12018-11-06
50090-2548-2EA - Each50090-25482ba9b2e8-68b0-4c8e-b7e5-a48112b3de3a12018-11-06
50090-2548-3EA - Each50090-2548595709a9-4c95-4260-97a3-ea186a98cae712018-11-06
50090-2548-4EA - Each50090-2548822c441c-f9a8-40a5-befe-fb114ec08e8f12018-11-06
50090-2548-5EA - Each50090-2548232f78e6-c7b3-42fb-b404-f69c5cea014412018-11-06
50090-2548-7EA - Each50090-25486163dabd-1d5d-43cf-94df-44cd55c9e3ad12018-11-06
50090-2548-8EA - Each50090-2548c38b67fb-6732-4635-8ccc-b36509b1272312018-11-06
50090-2548-9EA - Each50090-2548a9696a99-1e42-4b07-8912-9cf87a421ab912019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2548IBUPROFEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]55Current NDC, Legacy NDC, 9 package rows20250510_51de1183-d226-4869-a00a-f6c74e126a39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN51de1183-d226-4869-a00a-f6c74e126a3955
197806ibuprofen 600 MG Oral TabletPSN51de1183-d226-4869-a00a-f6c74e126a3955
197807ibuprofen 800 MG Oral TabletPSN51de1183-d226-4869-a00a-f6c74e126a3955
197805ibuprofen 400 MG Oral TabletSCD51de1183-d226-4869-a00a-f6c74e126a3955
197806ibuprofen 600 MG Oral TabletSCD51de1183-d226-4869-a00a-f6c74e126a3955
197807ibuprofen 800 MG Oral TabletSCD51de1183-d226-4869-a00a-f6c74e126a3955

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2548-05009025480010 TABLET, FILM COATED in 1 BOTTLE (50090-2548-0) 2017-02-130000-00-00NoNoCurrent
50090-2548-15009025480115 TABLET, FILM COATED in 1 BOTTLE (50090-2548-1) 2016-12-080000-00-00NoNoCurrent
50090-2548-25009025480230 TABLET, FILM COATED in 1 BOTTLE (50090-2548-2) 2016-10-200000-00-00NoNoCurrent
50090-2548-35009025480345 TABLET, FILM COATED in 1 BOTTLE (50090-2548-3) 2017-01-060000-00-00NoNoCurrent
50090-2548-45009025480460 TABLET, FILM COATED in 1 BOTTLE (50090-2548-4) 2016-10-270000-00-00NoNoCurrent
50090-2548-550090254805100 TABLET, FILM COATED in 1 BOTTLE (50090-2548-5) 2016-10-240000-00-00NoNoCurrent
50090-2548-75009025480721 TABLET, FILM COATED in 1 BOTTLE (50090-2548-7) 2016-10-260000-00-00NoNoCurrent
50090-2548-85009025480812 TABLET, FILM COATED in 1 BOTTLE (50090-2548-8) 2016-12-080000-00-00NoNoCurrent
50090-2548-95009025480940 TABLET, FILM COATED in 1 BOTTLE (50090-2548-9) 2016-11-010000-00-00NoNoCurrent