FDA.reportPublic FDA data

Ibuprofen

Product NDC
49483-133
11-digit product format
494830133
Labeler code
49483
Product ID
49483-133_059c51fc-6904-a427-e063-6294a90a7f69
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen Capsules 200 mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC.
Application
ANDA079205
Marketing category
ANDA
Marketing start
2021-07-27
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
Rxcui310964

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
49483-133-12Ibuprofen120 in 1 BOTTLECAPSULE, LIQUID FILLED1203
49483-133-20Ibuprofen200 in 1 BOTTLECAPSULE, LIQUID FILLED2003
49483-133-23Ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED203
49483-133-23Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED13
49483-133-31Ibuprofen300 in 1 BOTTLECAPSULE, LIQUID FILLED3003
49483-133-37Ibuprofen160 in 1 BOTTLECAPSULE, LIQUID FILLED1603
49483-133-80Ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-133IBUPROFEN (IBUPROFEN CAPSULES 200 MG) CAPSULE, LIQUID FILLED [TIME CAP LABORATORIES, INC.]3Current NDC, Legacy NDC, 7 package rows20230918_c7c51cf3-9e95-f8d0-e053-2995a90a7371.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNc7c51cf3-9e95-f8d0-e053-2995a90a73713
310964ibuprofen 200 MG Oral CapsuleSCDc7c51cf3-9e95-f8d0-e053-2995a90a73713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-133-1249483013312120 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-12) 2022-06-160000-00-00NoNoCurrent
49483-133-2049483013320200 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-20) 2022-06-160000-00-00NoNoCurrent
49483-133-23494830133231 BOTTLE in 1 CARTON (49483-133-23) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-06-160000-00-00NoNoCurrent
49483-133-3149483013331300 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-31) 2021-07-270000-00-00NoNoCurrent
49483-133-3749483013337160 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-37) 2023-09-16NoNoCurrent
49483-133-804948301338080 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-133-80) 2022-06-160000-00-00NoNoCurrent