IBUPROFEN

Product NDC
71335-1396
11-digit product format
713351396
Labeler code
71335
Product ID
71335-1396_840d6421-5e3e-4933-84fb-e5676439b9a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090796
Marketing category
ANDA
Marketing start
2015-12-30
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
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
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805, 197806, 197807

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
71335-1396-0IBUPROFEN84 in 1 BOTTLETABLET, FILM COATED844
71335-1396-1IBUPROFEN20 in 1 BOTTLETABLET, FILM COATED204
71335-1396-2IBUPROFEN15 in 1 BOTTLETABLET, FILM COATED154
71335-1396-3IBUPROFEN40 in 1 BOTTLETABLET, FILM COATED404
71335-1396-4IBUPROFEN21 in 1 BOTTLETABLET, FILM COATED214
71335-1396-5IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED304
71335-1396-6IBUPROFEN90 in 1 BOTTLETABLET, FILM COATED904
71335-1396-7IBUPROFEN100 in 1 BOTTLETABLET, FILM COATED1004
71335-1396-8IBUPROFEN120 in 1 BOTTLETABLET, FILM COATED1204
71335-1396-9IBUPROFEN60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1396-5EA - Each71335-13968f452873-373f-42c9-8eae-818926d6472812020-06-05
71335-1396-6EA - Each71335-139670301802-d476-443b-9cc4-6d52d6252b3312020-06-05
71335-1396-7EA - Each71335-1396a88a4213-7f78-4c06-8b1f-7e9d4273da0312020-06-05
71335-1396-9EA - Each71335-139674a1405d-fbcc-45d0-904c-a7336634385c12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1396IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20200529_6d189e86-4c36-43f5-b406-a342458d4155.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN6d189e86-4c36-43f5-b406-a342458d41554
197806ibuprofen 600 MG Oral TabletPSN6d189e86-4c36-43f5-b406-a342458d41554
197807ibuprofen 800 MG Oral TabletPSN6d189e86-4c36-43f5-b406-a342458d41554
197805ibuprofen 400 MG Oral TabletSCD6d189e86-4c36-43f5-b406-a342458d41554
197806ibuprofen 600 MG Oral TabletSCD6d189e86-4c36-43f5-b406-a342458d41554
197807ibuprofen 800 MG Oral TabletSCD6d189e86-4c36-43f5-b406-a342458d41554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1396-07133513960084 TABLET, FILM COATED in 1 BOTTLE (71335-1396-0) 2019-11-180000-00-00NoNoCurrent
71335-1396-17133513960120 TABLET, FILM COATED in 1 BOTTLE (71335-1396-1) 2019-11-180000-00-00NoNoCurrent
71335-1396-27133513960215 TABLET, FILM COATED in 1 BOTTLE (71335-1396-2) 2019-11-180000-00-00NoNoCurrent
71335-1396-37133513960340 TABLET, FILM COATED in 1 BOTTLE (71335-1396-3) 2019-11-180000-00-00NoNoCurrent
71335-1396-47133513960421 TABLET, FILM COATED in 1 BOTTLE (71335-1396-4) 2019-11-180000-00-00NoNoCurrent
71335-1396-57133513960530 TABLET, FILM COATED in 1 BOTTLE (71335-1396-5) 2019-11-180000-00-00NoNoCurrent
71335-1396-67133513960690 TABLET, FILM COATED in 1 BOTTLE (71335-1396-6) 2019-11-180000-00-00NoNoCurrent
71335-1396-771335139607100 TABLET, FILM COATED in 1 BOTTLE (71335-1396-7) 2019-11-180000-00-00NoNoCurrent
71335-1396-871335139608120 TABLET, FILM COATED in 1 BOTTLE (71335-1396-8) 2019-11-180000-00-00NoNoCurrent
71335-1396-97133513960960 TABLET, FILM COATED in 1 BOTTLE (71335-1396-9) 2019-11-180000-00-00NoNoCurrent