FDA.reportPublic FDA data

Ibuprofen

Product NDC
54348-835
11-digit product format
543480835
Labeler code
54348
Product ID
54348-835_eaa5cc60-19cc-a3f1-e053-2995a90a968f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA091625
Marketing category
ANDA
Marketing start
2019-07-11
Substance
IBUPROFEN
Active strength
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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
54348-835-00Ibuprofen1 in 1 BOXTABLET, FILM COATED12
54348-835-00Ibuprofen1 in 1 BOTTLETABLET, FILM COATED12
54348-835-08Ibuprofen8 in 1 BOTTLETABLET, FILM COATED82
54348-835-08Ibuprofen1 in 1 BOXTABLET, FILM COATED12
54348-835-10Ibuprofen1 in 1 BOXTABLET, FILM COATED12
54348-835-10Ibuprofen10 in 1 BOTTLETABLET, FILM COATED102
54348-835-12Ibuprofen12 in 1 BOTTLETABLET, FILM COATED122
54348-835-12Ibuprofen1 in 1 BOXTABLET, FILM COATED12
54348-835-20Ibuprofen20 in 1 BOTTLETABLET, FILM COATED202
54348-835-20Ibuprofen1 in 1 BOXTABLET, FILM COATED12
54348-835-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED302
54348-835-30Ibuprofen1 in 1 BOXTABLET, FILM COATED12
54348-835-60Ibuprofen1 in 1 BOXTABLET, FILM COATED12
54348-835-60Ibuprofen60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-835IBUPROFEN TABLET, FILM COATED [PHARMPAK, INC.]2Current NDC, Legacy NDC, 14 package rows20221011_bb6d0547-c113-42f9-8bf2-c227a55ab758.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNbb6d0547-c113-42f9-8bf2-c227a55ab7582
197805ibuprofen 400 MG Oral TabletSCDbb6d0547-c113-42f9-8bf2-c227a55ab7582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-835-00543480835001 BOTTLE in 1 BOX (54348-835-00) / 1 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-110000-00-00NoNoCurrent
54348-835-08543480835081 BOTTLE in 1 BOX (54348-835-08) / 8 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-110000-00-00NoNoCurrent
54348-835-10543480835101 BOTTLE in 1 BOX (54348-835-10) / 10 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-110000-00-00NoNoCurrent
54348-835-12543480835121 BOTTLE in 1 BOX (54348-835-12) / 12 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-110000-00-00NoNoCurrent
54348-835-20543480835201 BOTTLE in 1 BOX (54348-835-20) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-110000-00-00NoNoCurrent
54348-835-30543480835301 BOTTLE in 1 BOX (54348-835-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-110000-00-00NoNoCurrent
54348-835-60543480835601 BOTTLE in 1 BOX (54348-835-60) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-07-110000-00-00NoNoCurrent