FDA.reportPublic FDA data

basic care ibuprofen

Product NDC
72288-500
11-digit product format
722880500
Labeler code
72288
Product ID
72288-500_4909f55c-5f78-4a59-8b77-b2767d0c7345
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA203599
Marketing category
ANDA
Marketing start
2021-10-14
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
basic care 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
72288-500-06basic care ibuprofen160 in 1 BOTTLECAPSULE, LIQUID FILLED1604
72288-500-06basic care ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED14
72288-500-87basic care ibuprofen300 in 1 BOTTLECAPSULE, LIQUID FILLED3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-500BASIC CARE IBUPROFEN (IBUPROFEN) CAPSULE, LIQUID FILLED [AMAZON.COM SERVICES LLC]4Current NDC, Legacy NDC, 3 package rows20250322_25bc5cc2-9b6a-47e4-8b3d-2bb370907b61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN25bc5cc2-9b6a-47e4-8b3d-2bb370907b614
310964ibuprofen 200 MG Oral CapsuleSCD25bc5cc2-9b6a-47e4-8b3d-2bb370907b614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-500-06722880500061 BOTTLE in 1 CARTON (72288-500-06) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-10-140000-00-00NoNoCurrent
72288-500-8772288050087300 CAPSULE, LIQUID FILLED in 1 BOTTLE (72288-500-87) 2021-10-200000-00-00NoNoCurrent