FDA.reportPublic FDA data

IBUPROFEN

Product NDC
67060-001
11-digit product format
670600001
Labeler code
67060
Product ID
67060-001_feb250d0-cddb-448d-b08d-00a0fc091055
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN 200MG
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ADVANCED FIRST AID, INC.
Application
ANDA079174
Marketing category
ANDA
Marketing start
2015-04-09
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
67060-001-67IBUPROFEN2 in 1 PACKETTABLET, FILM COATED21
67060-001-67IBUPROFEN250 in 1 CARTONTABLET, FILM COATED2501
67060-001-68IBUPROFEN2 in 1 PACKETTABLET, FILM COATED21
67060-001-68IBUPROFEN100 in 1 CARTONTABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67060-001IBUPROFEN (IBUPROFEN 200MG) TABLET, FILM COATED [ADVANCED FIRST AID, INC.]1Current NDC, Legacy NDC, 4 package rows20180723_564e9910-b491-4129-a4f1-68216267623b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN564e9910-b491-4129-a4f1-68216267623b1
310965ibuprofen 200 MG Oral TabletSCD564e9910-b491-4129-a4f1-68216267623b1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY564e9910-b491-4129-a4f1-68216267623b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67060-001-6767060000167250 PACKET in 1 CARTON (67060-001-67) / 2 TABLET, FILM COATED in 1 PACKET250 packet2015-04-090000-00-00NoNoCurrent
67060-001-6867060000168100 PACKET in 1 CARTON (67060-001-68) / 2 TABLET, FILM COATED in 1 PACKET100 packet2015-04-090000-00-00NoNoCurrent