FDA.reportPublic FDA data

basic care ibuprofen

Product NDC
72288-517
11-digit product format
722880517
Labeler code
72288
Product ID
72288-517_80c1f064-67a6-4bc1-8943-0da0bfbeedd4
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA077349
Marketing category
ANDA
Marketing start
2021-12-01
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
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
72288-517-78basic care ibuprofen1 in 1 CARTONTABLET, FILM COATED14
72288-517-78basic care ibuprofen100 in 1 BOTTLETABLET, FILM COATED1004
72288-517-90basic care ibuprofen500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-517BASIC CARE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [AMAZON.COM SERVICES LLC]4Current NDC, Legacy NDC, 3 package rows20240315_5ada3dbe-af87-49db-a6b0-0a1c02111cbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN5ada3dbe-af87-49db-a6b0-0a1c02111cbf4
310965ibuprofen 200 MG Oral TabletSCD5ada3dbe-af87-49db-a6b0-0a1c02111cbf4
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY5ada3dbe-af87-49db-a6b0-0a1c02111cbf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-517-78722880517781 BOTTLE in 1 CARTON (72288-517-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-05-050000-00-00NoNoCurrent
72288-517-9072288051790500 TABLET, FILM COATED in 1 BOTTLE (72288-517-90) 2021-12-010000-00-00NoNoCurrent