FDA.reportPublic FDA data

Ibuprofen

Product NDC
30142-053
11-digit product format
301420053
Labeler code
30142
Product ID
30142-053_f0d5fbf0-cf4f-218d-e053-2a95a90ada47
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
KROGER COMPANY
Application
ANDA078682
Marketing category
ANDA
Marketing start
2019-05-03
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
30142-053-26Ibuprofen200 in 1 BOTTLECAPSULE, LIQUID FILLED2003
30142-053-82Ibuprofen40 in 1 BOTTLECAPSULE, LIQUID FILLED403
30142-053-82Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED13
30142-053-83Ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED203
30142-053-83Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED13
30142-053-84Ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED803
30142-053-85Ibuprofen160 in 1 BOTTLECAPSULE, LIQUID FILLED1603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-053IBUPROFEN CAPSULE, LIQUID FILLED [KROGER COMPANY]3Current NDC, Legacy NDC, 7 package rows20221229_3b95dcbf-aef1-44b5-a2c4-5ce93c57ff1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN3b95dcbf-aef1-44b5-a2c4-5ce93c57ff1d3
310964ibuprofen 200 MG Oral CapsuleSCD3b95dcbf-aef1-44b5-a2c4-5ce93c57ff1d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-053-2630142005326200 CAPSULE, LIQUID FILLED in 1 BOTTLE (30142-053-26) 2019-10-090000-00-00NoNoCurrent
30142-053-82301420053821 BOTTLE in 1 CARTON (30142-053-82) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-05-030000-00-00NoNoCurrent
30142-053-83301420053831 BOTTLE in 1 CARTON (30142-053-83) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-05-030000-00-00NoNoCurrent
30142-053-843014200538480 CAPSULE, LIQUID FILLED in 1 BOTTLE (30142-053-84) 2019-05-030000-00-00NoNoCurrent
30142-053-8530142005385160 CAPSULE, LIQUID FILLED in 1 BOTTLE (30142-053-85) 2019-05-030000-00-00NoNoCurrent