FDA.reportPublic FDA data

Ibuprofen

Product NDC
66715-9819
11-digit product format
667159819
Labeler code
66715
Product ID
66715-9819_e5bf5e09-7d43-6314-e053-2a95a90a2325
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen tablet, film-coated
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
ANDA075010
Marketing category
ANDA
Marketing start
2014-09-12
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
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
66715-9819-7Ibuprofen2 in 1 POUCHTABLET, FILM COATED21
66715-9819-7Ibuprofen50 in 1 BOX, UNIT-DOSETABLET, FILM COATED501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9819IBUPROFEN (IBUPROFEN TABLET, FILM-COATED) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]1Current NDC, Legacy NDC, 2 package rows20220811_e5bf5e09-7d42-6314-e053-2a95a90a2325.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNe5bf5e09-7d42-6314-e053-2a95a90a23251
310965ibuprofen 200 MG Oral TabletSCDe5bf5e09-7d42-6314-e053-2a95a90a23251
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYe5bf5e09-7d42-6314-e053-2a95a90a23251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9819-76671598190750 POUCH in 1 BOX, UNIT-DOSE (66715-9819-7) / 2 TABLET, FILM COATED in 1 POUCH50 pouch2014-09-120000-00-00NoNoCurrent