FDA.reportPublic FDA data

IBUPROFEN 100

Product NDC
73598-1102
11-digit product format
735981102
Labeler code
73598
Product ID
73598-1102_e9689442-8930-48ff-b766-3b15aca6b52a
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
JHK Inc dba American Safety & First Aid
Application
ANDA072096
Marketing category
ANDA
Marketing start
2000-02-02
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 100
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73598-1102-12024-05-07C16284748780-11030e365-6f4b-111a-e063-dadaa90a10e2IBUPROFEN
73598-1102-12024-01-30C16284748780-11030e365-6f4b-111a-e063-dadaa90a10e2IBUPROFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-1102-1IBUPROFEN 1002 in 1 PACKETTABLET, COATED22
73598-1102-1IBUPROFEN 10050 in 1 BOXTABLET, COATED502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73598-1102IBUPROFEN 100 (IBUPROFEN) TABLET, COATED IBUPROFEN 250 (IBUPROFEN) TABLET, COATED [JHK INC DBA AMERICAN SAFETY & FIRST AID]2Current NDC, Legacy NDC, 2 package rows20240509_218f6df9-dd04-45b6-8a45-3276691abee2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN218f6df9-dd04-45b6-8a45-3276691abee22
310965ibuprofen 200 MG Oral TabletSCD218f6df9-dd04-45b6-8a45-3276691abee22
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY218f6df9-dd04-45b6-8a45-3276691abee22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73598-1102-17359811020150 PACKET in 1 BOX (73598-1102-1) / 2 TABLET, COATED in 1 PACKET50 packet2000-02-020000-00-00NoNoCurrent