FDA.reportPublic FDA data

Ibuprofen

Product NDC
68210-8100
11-digit product format
682108100
Labeler code
68210
Product ID
68210-8100_2a81131c-e4d7-6084-e063-6394a90a8100
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Spirit Pharmaceutical LLC
Application
ANDA079174
Marketing category
ANDA
Marketing start
2020-03-10
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
68210-8100-2Ibuprofen1 in 1 CARTONTABLET, FILM COATED18
68210-8100-2Ibuprofen25 in 1 BOTTLETABLET, FILM COATED258
68210-8100-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED308
68210-8100-3Ibuprofen1 in 1 CARTONTABLET, FILM COATED18
68210-8100-5Ibuprofen1 in 1 CARTONTABLET, FILM COATED18
68210-8100-5Ibuprofen50 in 1 BOTTLETABLET, FILM COATED508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-8100IBUPROFEN TABLET, FILM COATED [SPIRIT PHARMACEUTICAL LLC]8Current NDC, Legacy NDC, 6 package rows20250101_a96d012e-b132-4e99-b84b-ccd3a9a05cbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNa96d012e-b132-4e99-b84b-ccd3a9a05cbb8
310965ibuprofen 200 MG Oral TabletSCDa96d012e-b132-4e99-b84b-ccd3a9a05cbb8
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYa96d012e-b132-4e99-b84b-ccd3a9a05cbb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-8100-2682108100021 BOTTLE in 1 CARTON (68210-8100-2) / 25 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-09-220000-00-00NoNoCurrent
68210-8100-3682108100031 BOTTLE in 1 CARTON (68210-8100-3) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-03-100000-00-00NoNoCurrent
68210-8100-5682108100051 BOTTLE in 1 CARTON (68210-8100-5) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-03-100000-00-00NoNoCurrent