FDA.reportPublic FDA data

Ibuprofen

Product NDC
69396-141
11-digit product format
693960141
Labeler code
69396
Product ID
69396-141_1ab8735e-147e-040c-e063-6394a90aff9b
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
ANDA207095
Marketing category
ANDA
Marketing start
2023-08-08
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
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
69396-141-01Ibuprofen50 in 1 BOXTABLET502
69396-141-01Ibuprofen2 in 1 PACKETTABLET22
69396-141-05Ibuprofen2 in 1 PACKETTABLET22
69396-141-05Ibuprofen10000 in 1 BAGTABLET100002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-141IBUPROFEN TABLET [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, 4 package rows20240614_114b5e23-6cd7-41d8-e063-6294a90aa0f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN114b5e23-6cd7-41d8-e063-6294a90aa0f02
310965ibuprofen 200 MG Oral TabletSCD114b5e23-6cd7-41d8-e063-6294a90aa0f02
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY114b5e23-6cd7-41d8-e063-6294a90aa0f02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-141-016939601410150 PACKET in 1 BOX (69396-141-01) / 2 TABLET in 1 PACKET50 packet2023-08-08NoNoCurrent
69396-141-056939601410510000 PACKET in 1 BAG (69396-141-05) / 2 TABLET in 1 PACKET10000 packet2023-08-08NoNoCurrent