FDA.reportPublic FDA data

Ibuprofen

Product NDC
50090-2625
11-digit product format
500902625
Labeler code
50090
Product ID
50090-2625_0228cbbe-e9b1-47bc-9d2a-0cc3d424f17a
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
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
50090-2625-02023-02-07C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-12023-02-07C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-22023-02-07C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-32023-02-07C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-42023-02-07C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-52023-02-07C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-72023-02-07C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-82023-02-07C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-92023-02-07C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-02023-01-30C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-12023-01-30C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-22023-01-30C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-32023-01-30C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-42023-01-30C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-52023-01-30C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-72023-01-30C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-82023-01-30C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2625-92023-01-30C16284748780-1f386c649-d546-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2625-0Ibuprofen10 in 1 BOTTLETABLET, FILM COATED1014
50090-2625-1Ibuprofen12 in 1 BOTTLETABLET, FILM COATED1214
50090-2625-2Ibuprofen16 in 1 BOTTLETABLET, FILM COATED1614
50090-2625-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED3014
50090-2625-4Ibuprofen60 in 1 BOTTLETABLET, FILM COATED6014
50090-2625-5Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10014
50090-2625-7Ibuprofen40 in 1 BOTTLETABLET, FILM COATED4014
50090-2625-8Ibuprofen20 in 1 BOTTLETABLET, FILM COATED2014
50090-2625-9Ibuprofen24 in 1 BOTTLETABLET, FILM COATED2414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2625-0EA - Each50090-262570292a17-4786-4d1c-9481-3a3d39a3344c12019-04-11
50090-2625-1EA - Each50090-26256c128e50-a9ff-4a2d-b3db-07092514374f12019-04-11
50090-2625-2EA - Each50090-2625b59d344e-aae2-4ad0-a0d7-da7d0383468712018-11-06
50090-2625-3EA - Each50090-2625e37d38b7-836a-427a-b36e-434443c09d5d12018-11-06
50090-2625-4EA - Each50090-2625baac12ae-000e-47ab-9d70-63af2a04cc6912018-11-06
50090-2625-5EA - Each50090-2625f1aed7c6-4dac-41b7-9c78-d4af480cf06e12018-11-06
50090-2625-7EA - Each50090-2625241f6af9-494a-4e63-b174-38464c267c5912018-11-06
50090-2625-8EA - Each50090-2625e7914f28-e1d9-45fd-b263-ec6c360888bb12018-11-06
50090-2625-9EA - Each50090-26259bae42ea-74c1-4cbb-acad-47700193410912019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2625IBUPROFEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 9 package rows20250510_25a94943-9acc-49c8-a4da-7e07bb2c35eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN25a94943-9acc-49c8-a4da-7e07bb2c35eb14
197806ibuprofen 600 MG Oral TabletSCD25a94943-9acc-49c8-a4da-7e07bb2c35eb14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2625-05009026250010 TABLET, FILM COATED in 1 BOTTLE (50090-2625-0) 2018-08-090000-00-00NoNoCurrent
50090-2625-15009026250112 TABLET, FILM COATED in 1 BOTTLE (50090-2625-1) 2017-01-030000-00-00NoNoCurrent
50090-2625-25009026250216 TABLET, FILM COATED in 1 BOTTLE (50090-2625-2) 2017-01-260000-00-00NoNoCurrent
50090-2625-35009026250330 TABLET, FILM COATED in 1 BOTTLE (50090-2625-3) 2016-11-210000-00-00NoNoCurrent
50090-2625-45009026250460 TABLET, FILM COATED in 1 BOTTLE (50090-2625-4) 2016-11-180000-00-00NoNoCurrent
50090-2625-550090262505100 TABLET, FILM COATED in 1 BOTTLE (50090-2625-5) 2016-11-170000-00-00NoNoCurrent
50090-2625-75009026250740 TABLET, FILM COATED in 1 BOTTLE (50090-2625-7) 2016-11-170000-00-00NoNoCurrent
50090-2625-85009026250820 TABLET, FILM COATED in 1 BOTTLE (50090-2625-8) 2016-11-290000-00-00NoNoCurrent
50090-2625-95009026250924 TABLET, FILM COATED in 1 BOTTLE (50090-2625-9) 2016-12-080000-00-00NoNoCurrent