FDA.reportPublic FDA data

Ibuprofen

Product NDC
83209-464
11-digit product format
832090464
Labeler code
83209
Product ID
83209-464_1a0301ba-9f66-ac39-e063-6394a90a34bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Boswell Pharmacy Services LLC d/b/a BPS Wholesale
Application
ANDA078558
Marketing category
ANDA
Marketing start
2024-06-03
Substance
IBUPROFEN
Active strength
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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
83209-464-09Ibuprofen9 in 1 BLISTER PACKTABLET91
83209-464-10Ibuprofen10 in 1 BLISTER PACKTABLET101
83209-464-12Ibuprofen12 in 1 BLISTER PACKTABLET121
83209-464-14Ibuprofen14 in 1 BLISTER PACKTABLET141
83209-464-15Ibuprofen15 in 1 BLISTER PACKTABLET151
83209-464-18Ibuprofen18 in 1 BLISTER PACKTABLET181
83209-464-20Ibuprofen20 in 1 BLISTER PACKTABLET201
83209-464-21Ibuprofen21 in 1 BLISTER PACKTABLET211
83209-464-24Ibuprofen24 in 1 BLISTER PACKTABLET241
83209-464-28Ibuprofen28 in 1 BLISTER PACKTABLET281
83209-464-30Ibuprofen30 in 1 BLISTER PACKTABLET301
83209-464-40Ibuprofen40 in 1 BLISTER PACKTABLET401
83209-464-60Ibuprofen60 in 1 BLISTER PACKTABLET601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN1a02fa34-b5ae-7183-e063-6294a90a3ae41
197805ibuprofen 400 MG Oral TabletSCD1a02fa34-b5ae-7183-e063-6294a90a3ae41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83209-464-09832090464099 TABLET in 1 BLISTER PACK (83209-464-09) 9 tablet2024-06-03NoNoCurrent
83209-464-108320904641010 TABLET in 1 BLISTER PACK (83209-464-10) 10 tablet2024-06-03NoNoCurrent
83209-464-128320904641212 TABLET in 1 BLISTER PACK (83209-464-12) 12 tablet2024-06-03NoNoCurrent
83209-464-148320904641414 TABLET in 1 BLISTER PACK (83209-464-14) 14 tablet2024-06-03NoNoCurrent
83209-464-158320904641515 TABLET in 1 BLISTER PACK (83209-464-15) 15 tablet2024-06-03NoNoCurrent
83209-464-188320904641818 TABLET in 1 BLISTER PACK (83209-464-18) 18 tablet2024-06-03NoNoCurrent
83209-464-208320904642020 TABLET in 1 BLISTER PACK (83209-464-20) 20 tablet2024-06-03NoNoCurrent
83209-464-218320904642121 TABLET in 1 BLISTER PACK (83209-464-21) 21 tablet2024-06-03NoNoCurrent
83209-464-248320904642424 TABLET in 1 BLISTER PACK (83209-464-24) 24 tablet2024-06-03NoNoCurrent
83209-464-288320904642828 TABLET in 1 BLISTER PACK (83209-464-28) 28 tablet2024-06-03NoNoCurrent
83209-464-308320904643030 TABLET in 1 BLISTER PACK (83209-464-30) 30 tablet2024-06-03NoNoCurrent
83209-464-408320904644040 TABLET in 1 BLISTER PACK (83209-464-40) 40 tablet2024-06-03NoNoCurrent
83209-464-608320904646060 TABLET in 1 BLISTER PACK (83209-464-60) 60 tablet2024-06-03NoNoCurrent