FDA.reportPublic FDA data

Ibuprofen, Caseys 4good

Product NDC
66715-6307
11-digit product format
667156307
Labeler code
66715
Product ID
66715-6307_2a91d7c3-f9ee-51a0-e063-6394a90a3bfc
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
ANDA079174
Marketing category
ANDA
Marketing start
2023-08-01
Marketing end
2027-04-01
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen, Caseys 4good

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
66715-6307-4Ibuprofen, Caseys 4good50 in 1 BOTTLE, PLASTICTABLET, FILM COATED502
66715-6307-4Ibuprofen, Caseys 4good1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6307IBUPROFEN, CASEYS 4GOOD (IBUPROFEN TABLETS) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]2Current NDC, 2 package rows20250101_04b3ad8b-bdf9-47f3-e063-6294a90ac350.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN04b3ad8b-bdf9-47f3-e063-6294a90ac3502
310965ibuprofen 200 MG Oral TabletSCD04b3ad8b-bdf9-47f3-e063-6294a90ac3502
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY04b3ad8b-bdf9-47f3-e063-6294a90ac3502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66715-6307-4667156307041 BOTTLE, PLASTIC in 1 CARTON (66715-6307-4) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-08-012027-04-01NoNoHistorical