FDA.reportPublic FDA data

Ibuprofen

Product NDC
71921-181
11-digit product format
719210181
Labeler code
71921
Product ID
71921-181_1f260910-03d9-fa2f-e063-6294a90ac0b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA071268
Marketing category
ANDA
Marketing start
2021-10-21
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
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
71921-181-01Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1005
71921-181-50Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-181-01EA - Each71921-181a9ad87c6-dc0a-4011-8d6d-09443086aaaf12021-12-08
71921-181-50EA - Each71921-1819e3a84e0-1363-46e7-a126-3d38962d8b0312021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-181IBUPROFEN TABLET, FILM COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]5Current NDC, Legacy NDC, 2 package rows20240809_c1733fdb-5eed-2094-e053-2995a90a6c8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNc1733fdb-5eed-2094-e053-2995a90a6c8e5
197806ibuprofen 600 MG Oral TabletPSNc1733fdb-5eed-2094-e053-2995a90a6c8e5
197807ibuprofen 800 MG Oral TabletPSNc1733fdb-5eed-2094-e053-2995a90a6c8e5
197805ibuprofen 400 MG Oral TabletSCDc1733fdb-5eed-2094-e053-2995a90a6c8e5
197806ibuprofen 600 MG Oral TabletSCDc1733fdb-5eed-2094-e053-2995a90a6c8e5
197807ibuprofen 800 MG Oral TabletSCDc1733fdb-5eed-2094-e053-2995a90a6c8e5
197806ibuprofen 600 MG Oral TabletPSNe17f9b41-cac3-5613-e053-2a95a90ab9092
197806ibuprofen 600 MG Oral TabletSCDe17f9b41-cac3-5613-e053-2a95a90ab9092
197806ibuprofen 600 MG Oral TabletPSNe005ae2e-4a46-0dfe-e053-2995a90a18ed1
197806ibuprofen 600 MG Oral TabletPSNf5cb3d67-9a8d-7830-e053-2995a90a90301
197806ibuprofen 600 MG Oral TabletSCDe005ae2e-4a46-0dfe-e053-2995a90a18ed1
197806ibuprofen 600 MG Oral TabletSCDf5cb3d67-9a8d-7830-e053-2995a90a90301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71921-181-0171921018101100 TABLET, FILM COATED in 1 BOTTLE (71921-181-01) 2021-10-210000-00-00NoNoCurrent
71921-181-5071921018150500 TABLET, FILM COATED in 1 BOTTLE (71921-181-50) 2021-10-210000-00-00NoNoCurrent