FDA.reportPublic FDA data

Ibuprofen

Product NDC
59651-362
11-digit product format
596510362
Labeler code
59651
Product ID
59651-362_5e595111-8477-4ec7-8d32-a0aeabc04e1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213794
Marketing category
ANDA
Marketing start
2020-05-08
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-362-01Ibuprofen100 in 1 BOTTLETABLET1006
59651-362-05Ibuprofen500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-362-01EA - Each59651-36217b9f96b-ab25-4ed1-bab8-b333ff2611de12021-01-08
59651-362-05EA - Each59651-362c362c039-2901-4258-9af1-fa163212cb1d12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-362IBUPROFEN TABLET [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 2 package rows20250216_00872852-680a-41b3-901b-b991b12a176d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNf24582be-8d70-4848-bd54-e55fa28f394f16
197807ibuprofen 800 MG Oral TabletSCDf24582be-8d70-4848-bd54-e55fa28f394f16
197807ibuprofen 800 MG Oral TabletPSNf1f1e0ac-6944-4123-9e08-1df91582d4579
197807ibuprofen 800 MG Oral TabletSCDf1f1e0ac-6944-4123-9e08-1df91582d4579
197807ibuprofen 800 MG Oral TabletPSNe5db46f3-043b-40ac-a89b-c90bd562e7b48
197807ibuprofen 800 MG Oral TabletPSN1aa11b52-1aca-9219-e063-6294a90a470f8
197807ibuprofen 800 MG Oral TabletSCDe5db46f3-043b-40ac-a89b-c90bd562e7b48
197807ibuprofen 800 MG Oral TabletSCD1aa11b52-1aca-9219-e063-6294a90a470f8
197807ibuprofen 800 MG Oral TabletPSNefbb5bca-1796-76d1-e053-2995a90a0bc87
197807ibuprofen 800 MG Oral TabletPSN3db0c659-cc43-45dc-8442-bc89093d94d77
197807ibuprofen 800 MG Oral TabletSCDefbb5bca-1796-76d1-e053-2995a90a0bc87
197807ibuprofen 800 MG Oral TabletSCD3db0c659-cc43-45dc-8442-bc89093d94d77
197805ibuprofen 400 MG Oral TabletPSN00872852-680a-41b3-901b-b991b12a176d6
197806ibuprofen 600 MG Oral TabletPSN00872852-680a-41b3-901b-b991b12a176d6
197807ibuprofen 800 MG Oral TabletPSN2fa4bfc8-386c-433b-bc46-24fc8ec1bca16
197807ibuprofen 800 MG Oral TabletPSN00872852-680a-41b3-901b-b991b12a176d6
197805ibuprofen 400 MG Oral TabletSCD00872852-680a-41b3-901b-b991b12a176d6
197806ibuprofen 600 MG Oral TabletSCD00872852-680a-41b3-901b-b991b12a176d6
197807ibuprofen 800 MG Oral TabletSCD2fa4bfc8-386c-433b-bc46-24fc8ec1bca16
197807ibuprofen 800 MG Oral TabletSCD00872852-680a-41b3-901b-b991b12a176d6
197807ibuprofen 800 MG Oral TabletPSN25d9f5fc-4d95-4018-add8-ba696b6079b25
197807ibuprofen 800 MG Oral TabletSCD25d9f5fc-4d95-4018-add8-ba696b6079b25
197807ibuprofen 800 MG Oral TabletPSN0a98cce4-f5c0-12a8-e063-6294a90a4e7e4
197807ibuprofen 800 MG Oral TabletSCD0a98cce4-f5c0-12a8-e063-6294a90a4e7e4
197807ibuprofen 800 MG Oral TabletPSN246b120e-3458-4721-bf95-82537feaa1313
197807ibuprofen 800 MG Oral TabletSCD246b120e-3458-4721-bf95-82537feaa1313
197805ibuprofen 400 MG Oral TabletPSN793e4b36-8208-4fa3-9f4f-9e9e726482802
197806ibuprofen 600 MG Oral TabletPSN793e4b36-8208-4fa3-9f4f-9e9e726482802
197807ibuprofen 800 MG Oral TabletPSN793e4b36-8208-4fa3-9f4f-9e9e726482802
197807ibuprofen 800 MG Oral TabletPSNf40fb0db-3dec-5b0d-e053-2a95a90a5ebd2
197807ibuprofen 800 MG Oral TabletPSN0bee69ff-cf76-175e-e063-6294a90a42f62
197805ibuprofen 400 MG Oral TabletSCD793e4b36-8208-4fa3-9f4f-9e9e726482802
197806ibuprofen 600 MG Oral TabletSCD793e4b36-8208-4fa3-9f4f-9e9e726482802
197807ibuprofen 800 MG Oral TabletSCD0bee69ff-cf76-175e-e063-6294a90a42f62
197807ibuprofen 800 MG Oral TabletSCD793e4b36-8208-4fa3-9f4f-9e9e726482802
197807ibuprofen 800 MG Oral TabletSCDf40fb0db-3dec-5b0d-e053-2a95a90a5ebd2
197807ibuprofen 800 MG Oral TabletPSNf5ca7588-30cd-60a7-e053-2995a90a21251
197807ibuprofen 800 MG Oral TabletPSN7acdd557-0b6c-48f5-9437-7bc567af1f851
197807ibuprofen 800 MG Oral TabletPSN50766a3d-1a22-be14-e063-6294a90a0ed21
197807ibuprofen 800 MG Oral TabletPSN1e1a7bd2-cd28-ffa0-e063-6394a90a090e1
197807ibuprofen 800 MG Oral TabletPSN31f61d5c-a3a3-3d47-e063-6394a90afb621
197807ibuprofen 800 MG Oral TabletPSN23fb1113-9f1c-88e0-e063-6394a90a44501
197807ibuprofen 800 MG Oral TabletSCD7acdd557-0b6c-48f5-9437-7bc567af1f851
197807ibuprofen 800 MG Oral TabletSCD50766a3d-1a22-be14-e063-6294a90a0ed21
197807ibuprofen 800 MG Oral TabletSCD1e1a7bd2-cd28-ffa0-e063-6394a90a090e1
197807ibuprofen 800 MG Oral TabletSCD31f61d5c-a3a3-3d47-e063-6394a90afb621
197807ibuprofen 800 MG Oral TabletSCDf5ca7588-30cd-60a7-e053-2995a90a21251
197807ibuprofen 800 MG Oral TabletSCD23fb1113-9f1c-88e0-e063-6394a90a44501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-362-0159651036201100 TABLET in 1 BOTTLE (59651-362-01) 100 tablet2020-05-080000-00-00NoNoCurrent
59651-362-0559651036205500 TABLET in 1 BOTTLE (59651-362-05) 500 tablet2020-05-080000-00-00NoNoCurrent
59651-362-10596510362101100 TABLET in 1 BAG (59651-362-10)1100 tablet08-MAY-20Current