FDA.reportPublic FDA data

AMAZON BASIC CARE IBUPROFEN

Product NDC
72288-513
11-digit product format
722880513
Labeler code
72288
Product ID
72288-513_b80a1013-82cd-440d-ad8d-5b648c55b74a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA208865
Marketing category
ANDA
Marketing start
2024-05-15
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
AMAZON BASIC CARE 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
72288-513-10AMAZON BASIC CARE IBUPROFEN100 in 1 BOTTLETABLET1003
72288-513-10AMAZON BASIC CARE IBUPROFEN1 in 1 CARTONTABLET13
72288-513-11AMAZON BASIC CARE IBUPROFEN1000 in 1 BOTTLE, PLASTICTABLET10003
72288-513-12AMAZON BASIC CARE IBUPROFEN1000 in 1 BOTTLETABLET10003
72288-513-20AMAZON BASIC CARE IBUPROFEN200 in 1 BOTTLETABLET2003
72288-513-20AMAZON BASIC CARE IBUPROFEN1 in 1 CARTONTABLET13
72288-513-49AMAZON BASIC CARE IBUPROFEN500 in 1 BOTTLETABLET5003
72288-513-50AMAZON BASIC CARE IBUPROFEN500 in 1 BOTTLE, PLASTICTABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-513AMAZON BASIC CARE IBUPROFEN (IBUPROFEN) TABLET [AMAZON.COM SERVICES LLC]2Current NDC, 8 package rows20240515_113dd693-6abe-1a0f-e063-6394a90a167e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN113dd693-6abe-1a0f-e063-6394a90a167e3
310965ibuprofen 200 MG Oral TabletSCD113dd693-6abe-1a0f-e063-6394a90a167e3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY113dd693-6abe-1a0f-e063-6394a90a167e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-513-10722880513101 BOTTLE in 1 CARTON (72288-513-10) / 100 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-513-11722880513111000 TABLET in 1 BOTTLE, PLASTIC (72288-513-11) 1000 tablet2024-05-15NoNoCurrent
72288-513-12722880513121000 TABLET in 1 BOTTLE (72288-513-12) 1000 tablet2025-06-06NoNoCurrent
72288-513-20722880513201 BOTTLE in 1 CARTON (72288-513-20) / 200 TABLET in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-513-4972288051349500 TABLET in 1 BOTTLE (72288-513-49) 500 tablet2024-05-15NoNoCurrent
72288-513-5072288051350500 TABLET in 1 BOTTLE, PLASTIC (72288-513-50) 500 tablet2024-05-15NoNoCurrent