Ibuprofen

Product NDC
58602-801
11-digit product format
586020801
Labeler code
58602
Product ID
58602-801_19309ddd-73dc-462a-afaa-899834a2d783
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA208865
Marketing category
ANDA
Marketing start
2017-11-08
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
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
58602-801-07Ibuprofen1 in 1 CARTONTABLET13
58602-801-07Ibuprofen24 in 1 BOTTLETABLET243
58602-801-12Ibuprofen1 in 1 CARTONTABLET13
58602-801-12Ibuprofen40 in 1 BOTTLETABLET403
58602-801-14Ibuprofen1 in 1 CARTONTABLET13
58602-801-14Ibuprofen50 in 1 BOTTLETABLET503
58602-801-15Ibuprofen60 in 1 BOTTLETABLET603
58602-801-15Ibuprofen1 in 1 CARTONTABLET13
58602-801-19Ibuprofen90 in 1 BOTTLETABLET903
58602-801-19Ibuprofen1 in 1 CARTONTABLET13
58602-801-21Ibuprofen100 in 1 BOTTLETABLET1003
58602-801-21Ibuprofen1 in 1 CARTONTABLET13
58602-801-29Ibuprofen150 in 1 BOTTLETABLET1503
58602-801-29Ibuprofen1 in 1 CARTONTABLET13
58602-801-34Ibuprofen1 in 1 CARTONTABLET13
58602-801-34Ibuprofen200 in 1 BOTTLETABLET2003
58602-801-35Ibuprofen225 in 1 BOTTLETABLET2253
58602-801-35Ibuprofen1 in 1 CARTONTABLET13
58602-801-36Ibuprofen250 in 1 BOTTLETABLET2503
58602-801-36Ibuprofen1 in 1 CARTONTABLET13
58602-801-38Ibuprofen300 in 1 BOTTLETABLET3003
58602-801-40Ibuprofen500 in 1 BOTTLETABLET5003
58602-801-41Ibuprofen1000 in 1 BOTTLETABLET10003
58602-801-59Ibuprofen1500 in 1 BOTTLETABLET15003
58602-801-87Ibuprofen550 in 1 BOTTLETABLET5503
58602-801-88Ibuprofen750 in 1 BOTTLETABLET7503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-801IBUPROFEN TABLET [AUROHEALTH LLC]3Current NDC, Legacy NDC, 26 package rows20220310_0ade8ee2-7c74-4b05-925e-d92742fc2b90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN0ade8ee2-7c74-4b05-925e-d92742fc2b903
310965ibuprofen 200 MG Oral TabletSCD0ade8ee2-7c74-4b05-925e-d92742fc2b903
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY0ade8ee2-7c74-4b05-925e-d92742fc2b903

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-801-07586020801071 BOTTLE in 1 CARTON (58602-801-07) / 24 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-801-12586020801121 BOTTLE in 1 CARTON (58602-801-12) / 40 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-801-14586020801141 BOTTLE in 1 CARTON (58602-801-14) / 50 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-801-15586020801151 BOTTLE in 1 CARTON (58602-801-15) / 60 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-801-19586020801191 BOTTLE in 1 CARTON (58602-801-19) / 90 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-801-21586020801211 BOTTLE in 1 CARTON (58602-801-21) / 100 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-801-29586020801291 BOTTLE in 1 CARTON (58602-801-29) / 150 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-801-34586020801341 BOTTLE in 1 CARTON (58602-801-34) / 200 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-801-35586020801351 BOTTLE in 1 CARTON (58602-801-35) / 225 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-801-36586020801361 BOTTLE in 1 CARTON (58602-801-36) / 250 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-801-3858602080138300 TABLET in 1 BOTTLE (58602-801-38) 300 tablet2017-11-080000-00-00NoNoCurrent
58602-801-4058602080140500 TABLET in 1 BOTTLE (58602-801-40) 500 tablet2017-11-080000-00-00NoNoCurrent
58602-801-41586020801411000 TABLET in 1 BOTTLE (58602-801-41) 1000 tablet2017-11-080000-00-00NoNoCurrent
58602-801-59586020801591500 TABLET in 1 BOTTLE (58602-801-59) 1500 tablet2017-11-080000-00-00NoNoCurrent
58602-801-8758602080187550 TABLET in 1 BOTTLE (58602-801-87) 550 tablet2017-11-080000-00-00NoNoCurrent
58602-801-8858602080188750 TABLET in 1 BOTTLE (58602-801-88) 750 tablet2017-11-080000-00-00NoNoCurrent