FDA.reportPublic FDA data

Ibuprofen

Product NDC
49483-114
11-digit product format
494830114
Labeler code
49483
Product ID
49483-114_375d8923-4e92-d631-e063-6294a90a20eb
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TIME CAP LABORATORIES,INC
Application
ANDA091239
Marketing category
ANDA
Marketing start
2016-03-22
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
49483-114-10Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED100012
49483-114-17Ibuprofen200 in 1 BOTTLETABLET, FILM COATED20012
49483-114-50Ibuprofen500 in 1 BOTTLETABLET, FILM COATED50012
49483-114-73Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-114IBUPROFEN TABLET, FILM COATED IBUPROFEN TABLET, FILM COATED IBUPROFEN (IBUPFROFEN) TABLET, FILM COATED [TIME CAP LABORATORIES,INC]11Current NDC, Legacy NDC, 4 package rows20231123_f58d35f9-e44b-417b-98ce-0766b537cd2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNf58d35f9-e44b-417b-98ce-0766b537cd2f12
310965ibuprofen 200 MG Oral TabletSCDf58d35f9-e44b-417b-98ce-0766b537cd2f12
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYf58d35f9-e44b-417b-98ce-0766b537cd2f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-114-10494830114101000 TABLET, FILM COATED in 1 BOTTLE (49483-114-10) 2021-09-090000-00-00NoNoCurrent
49483-114-1749483011417200 TABLET, FILM COATED in 1 BOTTLE (49483-114-17) 2023-08-19NoNoCurrent
49483-114-5049483011450500 TABLET, FILM COATED in 1 BOTTLE (49483-114-50) 2021-09-090000-00-00NoNoCurrent
49483-114-7349483011473100 TABLET, FILM COATED in 1 BOTTLE (49483-114-73) 2023-11-18NoNoCurrent