Ibuprofen

Product NDC
55301-291
11-digit product format
553010291
Labeler code
55301
Product ID
55301-291_dbb36317-703f-47d5-bdb5-eb936c415cbf
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
ANDA075010
Marketing category
ANDA
Marketing start
1988-05-24
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
55301-291-03Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1016
55301-291-03Ibuprofen1 in 1 PACKAGETABLET, FILM COATED116
55301-291-06Ibuprofen200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20016
55301-291-12Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016
55301-291-12Ibuprofen1 in 1 CARTONTABLET, FILM COATED116
55301-291-14Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50016

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-291IBUPROFEN TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]15Current NDC, Legacy NDC, 6 package rows20240623_718a4b73-5f46-4676-afda-f0b4819f5862.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN718a4b73-5f46-4676-afda-f0b4819f586216
310965ibuprofen 200 MG Oral TabletSCD718a4b73-5f46-4676-afda-f0b4819f586216
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY718a4b73-5f46-4676-afda-f0b4819f586216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55301-291-03553010291031 BOTTLE, PLASTIC in 1 PACKAGE (55301-291-03) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
55301-291-0655301029106200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55301-291-06) 1988-05-240000-00-00NoNoCurrent
55301-291-12553010291121 BOTTLE, PLASTIC in 1 CARTON (55301-291-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
55301-291-1455301029114500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55301-291-14) 1988-05-240000-00-00NoNoCurrent