FDA.reportPublic FDA data

Ibuprofen

Product NDC
54162-941
11-digit product format
541620941
Labeler code
54162
Product ID
54162-941_f6080edf-c278-4721-8335-4c299adf0c9e
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Geritrex LLC
Application
ANDA075010
Marketing category
ANDA
Marketing start
2018-10-15
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
54162-941-00Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, COATED1001
54162-941-90Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET, COATED10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-941-00EA - Each54162-941cb2042f1-0675-4cf8-ae8b-7b79c2643a8912019-05-02
54162-941-90EA - Each54162-941d1f6b409-2b1d-4588-9969-f1da887bf16912019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-941IBUPROFEN TABLET, COATED [GERITREX LLC]1Current NDC, Legacy NDC, 2 package rows20181025_ca9498ec-755d-4a09-9504-210dd48d6fed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNb2faf52c-ba43-441e-956b-e13a69fdb1d51
310965ibuprofen 200 MG Oral TabletPSNca9498ec-755d-4a09-9504-210dd48d6fed1
310965ibuprofen 200 MG Oral TabletPSNddaafe5c-36b5-4d0b-a27a-dae266bed4fb1
310965ibuprofen 200 MG Oral TabletSCDb2faf52c-ba43-441e-956b-e13a69fdb1d51
310965ibuprofen 200 MG Oral TabletSCDca9498ec-755d-4a09-9504-210dd48d6fed1
310965ibuprofen 200 MG Oral TabletSCDddaafe5c-36b5-4d0b-a27a-dae266bed4fb1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYb2faf52c-ba43-441e-956b-e13a69fdb1d51
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYca9498ec-755d-4a09-9504-210dd48d6fed1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYddaafe5c-36b5-4d0b-a27a-dae266bed4fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54162-941-0054162094100100 TABLET, COATED in 1 BOTTLE, PLASTIC (54162-941-00) 2018-10-150000-00-00NoNoCurrent
54162-941-90541620941901000 TABLET, COATED in 1 BOTTLE, PLASTIC (54162-941-90) 2018-10-150000-00-00NoNoCurrent