Ibuprofen

Product NDC
59651-361
11-digit product format
596510361
Labeler code
59651
Product ID
59651-361_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
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
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
59651-361-01Ibuprofen100 in 1 BOTTLETABLET1006
59651-361-05Ibuprofen500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-361-01EA - Each59651-3614ca2e4e0-b3de-412b-a888-76da94e8e32112021-01-08
59651-361-05EA - Each59651-3615b633c52-a20b-477c-973c-861dc76508c112021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-361IBUPROFEN 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
197806ibuprofen 600 MG Oral TabletPSN8d5f7d2a-af48-4d47-8bf5-48f01c092d2414
197806ibuprofen 600 MG Oral TabletSCD8d5f7d2a-af48-4d47-8bf5-48f01c092d2414
197806ibuprofen 600 MG Oral TabletPSN4b75bd6f-5455-4237-991c-eacc0fdcf70913
197806ibuprofen 600 MG Oral TabletSCD4b75bd6f-5455-4237-991c-eacc0fdcf70913
197805ibuprofen 400 MG Oral TabletPSN00872852-680a-41b3-901b-b991b12a176d6
197806ibuprofen 600 MG Oral TabletPSN00872852-680a-41b3-901b-b991b12a176d6
197806ibuprofen 600 MG Oral TabletPSNf60445d3-807e-0bbf-e053-2995a90a12996
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
197806ibuprofen 600 MG Oral TabletSCDf60445d3-807e-0bbf-e053-2995a90a12996
197807ibuprofen 800 MG Oral TabletSCD00872852-680a-41b3-901b-b991b12a176d6
197806ibuprofen 600 MG Oral TabletPSN13fd4401-1821-4f2b-a44e-96aa2fa75b5c4
197806ibuprofen 600 MG Oral TabletSCD13fd4401-1821-4f2b-a44e-96aa2fa75b5c4
197806ibuprofen 600 MG Oral TabletPSN1ef5693b-d00a-28fb-e063-6294a90a7ede3
197806ibuprofen 600 MG Oral TabletPSN56f1d6a9-6804-4235-a600-f7c8e458f6933
197806ibuprofen 600 MG Oral TabletSCD1ef5693b-d00a-28fb-e063-6294a90a7ede3
197806ibuprofen 600 MG Oral TabletSCD56f1d6a9-6804-4235-a600-f7c8e458f6933
197805ibuprofen 400 MG Oral TabletPSN793e4b36-8208-4fa3-9f4f-9e9e726482802
197806ibuprofen 600 MG Oral TabletPSNf422c711-fe7d-dfa0-e053-2a95a90a1a512
197806ibuprofen 600 MG Oral TabletPSNfae53f7b-3948-2566-e053-6394a90aae362
197806ibuprofen 600 MG Oral TabletPSN793e4b36-8208-4fa3-9f4f-9e9e726482802
197806ibuprofen 600 MG Oral TabletPSN2144eff0-d7ab-486d-b116-a4ff3ae2afe22
197807ibuprofen 800 MG Oral TabletPSN793e4b36-8208-4fa3-9f4f-9e9e726482802
197805ibuprofen 400 MG Oral TabletSCD793e4b36-8208-4fa3-9f4f-9e9e726482802
197806ibuprofen 600 MG Oral TabletSCD793e4b36-8208-4fa3-9f4f-9e9e726482802
197806ibuprofen 600 MG Oral TabletSCDf422c711-fe7d-dfa0-e053-2a95a90a1a512
197806ibuprofen 600 MG Oral TabletSCD2144eff0-d7ab-486d-b116-a4ff3ae2afe22
197806ibuprofen 600 MG Oral TabletSCDfae53f7b-3948-2566-e053-6394a90aae362
197807ibuprofen 800 MG Oral TabletSCD793e4b36-8208-4fa3-9f4f-9e9e726482802
197806ibuprofen 600 MG Oral TabletPSN86fc38bc-7f54-4aab-9c4d-d0898a4381f91
197806ibuprofen 600 MG Oral TabletPSNebf2d6e1-3848-7523-e053-2a95a90a952f1
197806ibuprofen 600 MG Oral TabletPSN266c8441-f1ac-61f8-e063-6394a90a89c31
197806ibuprofen 600 MG Oral TabletPSNf64f9385-701d-440d-a53b-06267b454f101
197806ibuprofen 600 MG Oral TabletSCD86fc38bc-7f54-4aab-9c4d-d0898a4381f91
197806ibuprofen 600 MG Oral TabletSCDebf2d6e1-3848-7523-e053-2a95a90a952f1
197806ibuprofen 600 MG Oral TabletSCD266c8441-f1ac-61f8-e063-6394a90a89c31
197806ibuprofen 600 MG Oral TabletSCDf64f9385-701d-440d-a53b-06267b454f101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-361-0159651036101100 TABLET in 1 BOTTLE (59651-361-01) 100 tablet2020-05-080000-00-00NoNoCurrent
59651-361-0559651036105500 TABLET in 1 BOTTLE (59651-361-05) 500 tablet2020-05-080000-00-00NoNoCurrent
59651-361-22596510361222000 TABLET in 1 BAG (59651-361-22)2000 tablet08-MAY-20Current