FDA.reportPublic FDA data

ibuprofen

Product NDC
71205-357
11-digit product format
712050357
Labeler code
71205
Product ID
71205-357_c18cb763-af0c-4cc2-b7df-520835c91884
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA072096
Marketing category
ANDA
Marketing start
2018-09-20
Substance
IBUPROFEN
Active strength
200 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
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
71205-357-06ibuprofen6 in 1 BOTTLETABLET, FILM COATED64
71205-357-24ibuprofen24 in 1 BOTTLETABLET, FILM COATED244
71205-357-30ibuprofen30 in 1 BOTTLETABLET, FILM COATED304
71205-357-50ibuprofen50 in 1 BOTTLETABLET, FILM COATED504
71205-357-60ibuprofen60 in 1 BOTTLETABLET, FILM COATED604
71205-357-90ibuprofen90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-357-06EA - Each71205-357bedd50f8-14de-4b09-abd2-a5c0c15ae1bd12020-01-03
71205-357-24EA - Each71205-357ba94d8c3-e699-48d1-a09c-05d768a5c40212022-03-09
71205-357-30EA - Each71205-3576d2a4d5a-8474-42da-9153-2c357580c4f812020-01-03
71205-357-50EA - Each71205-357f6ad8153-0478-4882-a43d-e6fbbc31c73112020-01-03
71205-357-60EA - Each71205-35704cdad6c-9448-4822-b077-4e88b40a5a5e12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-357IBUPROFEN TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20220413_798d33b0-5d7a-4445-8a51-2a3d336f744a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN798d33b0-5d7a-4445-8a51-2a3d336f744a4
310965ibuprofen 200 MG Oral TabletSCD798d33b0-5d7a-4445-8a51-2a3d336f744a4
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY798d33b0-5d7a-4445-8a51-2a3d336f744a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-357-06712050357066 TABLET, FILM COATED in 1 BOTTLE (71205-357-06) 2019-11-120000-00-00NoNoCurrent
71205-357-247120503572424 TABLET, FILM COATED in 1 BOTTLE (71205-357-24) 2021-08-260000-00-00NoNoCurrent
71205-357-307120503573030 TABLET, FILM COATED in 1 BOTTLE (71205-357-30) 2019-11-120000-00-00NoNoCurrent
71205-357-507120503575050 TABLET, FILM COATED in 1 BOTTLE (71205-357-50) 2019-11-120000-00-00NoNoCurrent
71205-357-607120503576060 TABLET, FILM COATED in 1 BOTTLE (71205-357-60) 2019-11-120000-00-00NoNoCurrent
71205-357-907120503579090 TABLET, FILM COATED in 1 BOTTLE (71205-357-90) 2019-11-120000-00-00NoNoCurrent