FDA.reportPublic FDA data

Ibuprofen

Product NDC
71335-1073
11-digit product format
713351073
Labeler code
71335
Product ID
71335-1073_b89c7694-78ee-4955-b6fb-faee2398cf98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
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
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
71335-1073-0Ibuprofen84 in 1 BOTTLETABLET, FILM COATED846
71335-1073-1Ibuprofen20 in 1 BOTTLETABLET, FILM COATED206
71335-1073-2Ibuprofen15 in 1 BOTTLETABLET, FILM COATED156
71335-1073-3Ibuprofen40 in 1 BOTTLETABLET, FILM COATED406
71335-1073-4Ibuprofen21 in 1 BOTTLETABLET, FILM COATED216
71335-1073-5Ibuprofen30 in 1 BOTTLETABLET, FILM COATED306
71335-1073-6Ibuprofen90 in 1 BOTTLETABLET, FILM COATED906
71335-1073-7Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1006
71335-1073-8Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1206
71335-1073-9Ibuprofen60 in 1 BOTTLETABLET, FILM COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1073-3EA - Each71335-10731c199563-bfd9-42a7-bf4e-7be0f157a10e12025-08-11
71335-1073-5EA - Each71335-10730636f268-a6a4-49a1-8e8b-3275f02462ce12019-09-05
71335-1073-6EA - Each71335-10731d990f11-1c76-4327-9f63-238898234e2512019-09-05
71335-1073-9EA - Each71335-10733f3b878f-270a-4eb4-a776-df1fdf4960d512019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1073IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20240822_d0198bdc-fe2b-4b09-8f78-9e5a7f6ae784.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNd0198bdc-fe2b-4b09-8f78-9e5a7f6ae7846
197807ibuprofen 800 MG Oral TabletSCDd0198bdc-fe2b-4b09-8f78-9e5a7f6ae7846

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1073-07133510730084 TABLET, FILM COATED in 1 BOTTLE (71335-1073-0) 2021-12-280000-00-00NoNoCurrent
71335-1073-17133510730120 TABLET, FILM COATED in 1 BOTTLE (71335-1073-1) 2019-02-140000-00-00NoNoCurrent
71335-1073-27133510730215 TABLET, FILM COATED in 1 BOTTLE (71335-1073-2) 2019-02-130000-00-00NoNoCurrent
71335-1073-37133510730340 TABLET, FILM COATED in 1 BOTTLE (71335-1073-3) 2019-02-260000-00-00NoNoCurrent
71335-1073-47133510730421 TABLET, FILM COATED in 1 BOTTLE (71335-1073-4) 2019-02-140000-00-00NoNoCurrent
71335-1073-57133510730530 TABLET, FILM COATED in 1 BOTTLE (71335-1073-5) 2019-06-060000-00-00NoNoCurrent
71335-1073-67133510730690 TABLET, FILM COATED in 1 BOTTLE (71335-1073-6) 2019-02-210000-00-00NoNoCurrent
71335-1073-771335107307100 TABLET, FILM COATED in 1 BOTTLE (71335-1073-7) 2019-02-190000-00-00NoNoCurrent
71335-1073-871335107308120 TABLET, FILM COATED in 1 BOTTLE (71335-1073-8) 2019-07-180000-00-00NoNoCurrent
71335-1073-97133510730960 TABLET, FILM COATED in 1 BOTTLE (71335-1073-9) 2019-02-270000-00-00NoNoCurrent