Ibuprofen

Product NDC
65162-466
11-digit product format
651620466
Labeler code
65162
Product ID
65162-466_32c8853c-ed52-4791-9350-ab724724d342
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-466-03Ibuprofen30 in 1 BOTTLETABLET3010
65162-466-05Ibuprofen50 in 1 BOTTLETABLET5010
65162-466-06Ibuprofen60 in 1 BOTTLETABLET6010
65162-466-09Ibuprofen90 in 1 BOTTLETABLET9010
65162-466-10Ibuprofen100 in 1 BOTTLETABLET10010
65162-466-50Ibuprofen500 in 1 BOTTLETABLET50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-466-09EA - Each65162-466b6255185-b9d8-49f9-bcf5-1805ef7ca6b012018-02-20
65162-466-10EA - Each65162-4668bf87354-a6a5-4da2-af0f-79a6ba9e949512018-02-20
65162-466-50EA - Each65162-46678309891-5a27-4c3c-bd1f-fcf6355a468012018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-466IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS LLC]10Current NDC, Legacy NDC, 6 package rows20250123_17577b3b-e755-45d1-8b53-775d058578b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN17577b3b-e755-45d1-8b53-775d058578b210
197806ibuprofen 600 MG Oral TabletPSN17577b3b-e755-45d1-8b53-775d058578b210
197807ibuprofen 800 MG Oral TabletPSN17577b3b-e755-45d1-8b53-775d058578b210
197807ibuprofen 800 MG Oral TabletPSNaf9af7f4-6314-6217-e053-2995a90a5a0f10
197805ibuprofen 400 MG Oral TabletSCD17577b3b-e755-45d1-8b53-775d058578b210
197806ibuprofen 600 MG Oral TabletSCD17577b3b-e755-45d1-8b53-775d058578b210
197807ibuprofen 800 MG Oral TabletSCD17577b3b-e755-45d1-8b53-775d058578b210
197807ibuprofen 800 MG Oral TabletSCDaf9af7f4-6314-6217-e053-2995a90a5a0f10
197805ibuprofen 400 MG Oral TabletPSNe080f7da-a506-4c04-a227-c1be77234f017
197806ibuprofen 600 MG Oral TabletPSNe080f7da-a506-4c04-a227-c1be77234f017
197807ibuprofen 800 MG Oral TabletPSNe080f7da-a506-4c04-a227-c1be77234f017
197805ibuprofen 400 MG Oral TabletSCDe080f7da-a506-4c04-a227-c1be77234f017
197806ibuprofen 600 MG Oral TabletSCDe080f7da-a506-4c04-a227-c1be77234f017
197807ibuprofen 800 MG Oral TabletSCDe080f7da-a506-4c04-a227-c1be77234f017
197807ibuprofen 800 MG Oral TabletPSNe4bb22bb-6df6-4016-a023-0b454df9fb0b4
197807ibuprofen 800 MG Oral TabletSCDe4bb22bb-6df6-4016-a023-0b454df9fb0b4
197807ibuprofen 800 MG Oral TabletPSN67632de7-d232-4cd0-a960-c48837b9ff3d2
197807ibuprofen 800 MG Oral TabletPSNfc871659-ce41-1be6-e053-6294a90aa5e42
197807ibuprofen 800 MG Oral TabletSCDfc871659-ce41-1be6-e053-6294a90aa5e42
197807ibuprofen 800 MG Oral TabletSCD67632de7-d232-4cd0-a960-c48837b9ff3d2
197807ibuprofen 800 MG Oral TabletPSNd66ff766-bf1b-9025-e053-2a95a90a04ca1
197807ibuprofen 800 MG Oral TabletPSNb3383456-5385-73ba-e053-2a95a90a378d1
197807ibuprofen 800 MG Oral TabletPSN40202c76-4275-88fd-e063-6394a90a07b21
197807ibuprofen 800 MG Oral TabletPSNe69c6207-cb1c-7b7c-e053-2a95a90a35fd1
197807ibuprofen 800 MG Oral TabletPSNfa99f5ec-0306-473b-827f-86cd0a7978ec1
197807ibuprofen 800 MG Oral TabletPSN334e40f3-6da4-ecbe-e063-6294a90a35bf1
197807ibuprofen 800 MG Oral TabletSCDd66ff766-bf1b-9025-e053-2a95a90a04ca1
197807ibuprofen 800 MG Oral TabletSCDb3383456-5385-73ba-e053-2a95a90a378d1
197807ibuprofen 800 MG Oral TabletSCD40202c76-4275-88fd-e063-6394a90a07b21
197807ibuprofen 800 MG Oral TabletSCDe69c6207-cb1c-7b7c-e053-2a95a90a35fd1
197807ibuprofen 800 MG Oral TabletSCDfa99f5ec-0306-473b-827f-86cd0a7978ec1
197807ibuprofen 800 MG Oral TabletSCD334e40f3-6da4-ecbe-e063-6294a90a35bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-466-036516204660330 TABLET in 1 BOTTLE (65162-466-03) 30 tablet2009-11-230000-00-00NoNoCurrent
65162-466-056516204660550 TABLET in 1 BOTTLE (65162-466-05) 50 tablet2009-11-230000-00-00NoNoCurrent
65162-466-066516204660660 TABLET in 1 BOTTLE (65162-466-06) 60 tablet2009-11-230000-00-00NoNoCurrent
65162-466-096516204660990 TABLET in 1 BOTTLE (65162-466-09) 90 tablet2009-11-230000-00-00NoNoCurrent
65162-466-1065162046610100 TABLET in 1 BOTTLE (65162-466-10) 100 tablet2009-11-230000-00-00NoNoCurrent
65162-466-5065162046650500 TABLET in 1 BOTTLE (65162-466-50) 500 tablet2009-11-230000-00-00NoNoCurrent