ibuprofen

Product NDC
50090-5223
11-digit product format
500905223
Labeler code
50090
Product ID
50090-5223_f8123a23-e0b1-4762-aae1-88ca8948a96c
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA072096
Marketing category
ANDA
Marketing start
2018-09-20
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
50090-5223-02023-02-07C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-22023-02-07C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-32023-02-07C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-42023-02-07C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-52023-02-07C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-62023-02-07C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-72023-02-07C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-82023-02-07C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-02023-01-30C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-22023-01-30C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-32023-01-30C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-42023-01-30C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-52023-01-30C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-62023-01-30C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-72023-01-30C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts
50090-5223-82023-01-30C16284748780-1f386c649-e27b-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Ibuprofen Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5223-0ibuprofen50 in 1 BOTTLETABLET, FILM COATED509
50090-5223-2ibuprofen20 in 1 BOTTLETABLET, FILM COATED209
50090-5223-3ibuprofen24 in 1 BOTTLETABLET, FILM COATED249
50090-5223-4ibuprofen40 in 1 BOTTLETABLET, FILM COATED409
50090-5223-5ibuprofen30 in 1 BOTTLETABLET, FILM COATED309
50090-5223-6ibuprofen28 in 1 BOTTLETABLET, FILM COATED289
50090-5223-7ibuprofen60 in 1 BOTTLETABLET, FILM COATED609
50090-5223-8ibuprofen100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5223-0EA - Each50090-52231d5acd5b-5113-4d49-9155-dfd10b4e163412023-10-16
50090-5223-3EA - Each50090-52239524a8c8-a659-4557-a106-8f8dca04ae2712023-10-16
50090-5223-8EA - Each50090-522347e00c4f-cda4-4314-ad77-e99f80ba500012023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5223IBUPROFEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 8 package rows20250426_504c7e5d-e721-4df8-865b-8ea17559831d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN504c7e5d-e721-4df8-865b-8ea17559831d9
310965ibuprofen 200 MG Oral TabletSCD504c7e5d-e721-4df8-865b-8ea17559831d9
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY504c7e5d-e721-4df8-865b-8ea17559831d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5223-05009052230050 TABLET, FILM COATED in 1 BOTTLE (50090-5223-0) 2020-10-070000-00-00NoNoCurrent
50090-5223-25009052230220 TABLET, FILM COATED in 1 BOTTLE (50090-5223-2) 2020-10-070000-00-00NoNoCurrent
50090-5223-35009052230324 TABLET, FILM COATED in 1 BOTTLE (50090-5223-3) 2020-10-070000-00-00NoNoCurrent
50090-5223-45009052230440 TABLET, FILM COATED in 1 BOTTLE (50090-5223-4) 2020-10-070000-00-00NoNoCurrent
50090-5223-55009052230530 TABLET, FILM COATED in 1 BOTTLE (50090-5223-5) 2020-10-070000-00-00NoNoCurrent
50090-5223-65009052230628 TABLET, FILM COATED in 1 BOTTLE (50090-5223-6) 2020-10-070000-00-00NoNoCurrent
50090-5223-75009052230760 TABLET, FILM COATED in 1 BOTTLE (50090-5223-7) 2020-10-070000-00-00NoNoCurrent
50090-5223-850090522308100 TABLET, FILM COATED in 1 BOTTLE (50090-5223-8) 2020-10-070000-00-00NoNoCurrent