FDA.reportPublic FDA data

Ibuprofen

Product NDC
71335-1206
11-digit product format
713351206
Labeler code
71335
Product ID
71335-1206_cd0c9ccd-cf1d-46f9-9598-58b43ebcb239
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078329
Marketing category
ANDA
Marketing start
2018-08-24
Substance
IBUPROFEN
Active strength
800 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197807

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
71335-1206-0Ibuprofen84 in 1 BOTTLETABLET, FILM COATED844
71335-1206-1Ibuprofen20 in 1 BOTTLETABLET, FILM COATED204
71335-1206-2Ibuprofen15 in 1 BOTTLETABLET, FILM COATED154
71335-1206-3Ibuprofen40 in 1 BOTTLETABLET, FILM COATED404
71335-1206-4Ibuprofen21 in 1 BOTTLETABLET, FILM COATED214
71335-1206-5Ibuprofen30 in 1 BOTTLETABLET, FILM COATED304
71335-1206-6Ibuprofen90 in 1 BOTTLETABLET, FILM COATED904
71335-1206-7Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1004
71335-1206-8Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1204
71335-1206-9Ibuprofen60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1206-6EA - Each71335-1206b2580ccb-81a9-4db4-af8f-00fdcc7810b912019-12-10
71335-1206-9EA - Each71335-120640b65958-7b15-412d-a729-02ebc5c2a1a512019-08-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNc38a03fa-6b9a-4737-a848-063ca5c580b94
197807ibuprofen 800 MG Oral TabletSCDc38a03fa-6b9a-4737-a848-063ca5c580b94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1206-07133512060084 TABLET, FILM COATED in 1 BOTTLE (71335-1206-0) 2019-05-060000-00-00NoNoCurrent
71335-1206-17133512060120 TABLET, FILM COATED in 1 BOTTLE (71335-1206-1) 2019-09-050000-00-00NoNoCurrent
71335-1206-27133512060215 TABLET, FILM COATED in 1 BOTTLE (71335-1206-2) 2019-05-060000-00-00NoNoCurrent
71335-1206-37133512060340 TABLET, FILM COATED in 1 BOTTLE (71335-1206-3) 2019-09-100000-00-00NoNoCurrent
71335-1206-47133512060421 TABLET, FILM COATED in 1 BOTTLE (71335-1206-4) 2019-09-250000-00-00NoNoCurrent
71335-1206-57133512060530 TABLET, FILM COATED in 1 BOTTLE (71335-1206-5) 2019-05-080000-00-00NoNoCurrent
71335-1206-67133512060690 TABLET, FILM COATED in 1 BOTTLE (71335-1206-6) 2019-10-140000-00-00NoNoCurrent
71335-1206-771335120607100 TABLET, FILM COATED in 1 BOTTLE (71335-1206-7) 2019-10-100000-00-00NoNoCurrent
71335-1206-871335120608120 TABLET, FILM COATED in 1 BOTTLE (71335-1206-8) 2019-05-060000-00-00NoNoCurrent
71335-1206-97133512060960 TABLET, FILM COATED in 1 BOTTLE (71335-1206-9) 2019-05-060000-00-00NoNoCurrent