FDA.reportPublic FDA data

Ibuprofen

Product NDC
71335-1270
11-digit product format
713351270
Labeler code
71335
Product ID
71335-1270_99ce22f5-0b6e-42f3-8807-66fbebfedfd3
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
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
71335-1270-1Ibuprofen20 in 1 BOTTLETABLET, FILM COATED20102
71335-1270-2Ibuprofen30 in 1 BOTTLETABLET, FILM COATED30102
71335-1270-3Ibuprofen40 in 1 BOTTLETABLET, FILM COATED40102
71335-1270-4Ibuprofen60 in 1 BOTTLETABLET, FILM COATED60102
71335-1270-5Ibuprofen90 in 1 BOTTLETABLET, FILM COATED90102
71335-1270-6Ibuprofen120 in 1 BOTTLETABLET, FILM COATED120102
71335-1270-7Ibuprofen100 in 1 BOTTLETABLET, FILM COATED100102
71335-1270-8Ibuprofen21 in 1 BOTTLETABLET, FILM COATED21102
71335-1270-9Ibuprofen15 in 1 BOTTLETABLET, FILM COATED15102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1270-4EA - Each71335-127080b5cc06-0bab-40a2-a665-e893f0a9a53d12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1270IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 9 package rows20241030_1361b6d6-0443-460a-8446-41f63a1e28df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN1361b6d6-0443-460a-8446-41f63a1e28df102
197805ibuprofen 400 MG Oral TabletSCD1361b6d6-0443-460a-8446-41f63a1e28df102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1270-17133512700120 TABLET, FILM COATED in 1 BOTTLE (71335-1270-1) 2020-02-090000-00-00NoNoCurrent
71335-1270-27133512700230 TABLET, FILM COATED in 1 BOTTLE (71335-1270-2) 2020-02-090000-00-00NoNoCurrent
71335-1270-37133512700340 TABLET, FILM COATED in 1 BOTTLE (71335-1270-3) 2020-02-090000-00-00NoNoCurrent
71335-1270-47133512700460 TABLET, FILM COATED in 1 BOTTLE (71335-1270-4) 2020-02-090000-00-00NoNoCurrent
71335-1270-57133512700590 TABLET, FILM COATED in 1 BOTTLE (71335-1270-5) 2020-02-090000-00-00NoNoCurrent
71335-1270-671335127006120 TABLET, FILM COATED in 1 BOTTLE (71335-1270-6) 2020-02-090000-00-00NoNoCurrent
71335-1270-771335127007100 TABLET, FILM COATED in 1 BOTTLE (71335-1270-7) 2020-02-090000-00-00NoNoCurrent
71335-1270-87133512700821 TABLET, FILM COATED in 1 BOTTLE (71335-1270-8) 2020-02-090000-00-00NoNoCurrent
71335-1270-97133512700915 TABLET, FILM COATED in 1 BOTTLE (71335-1270-9) 2020-02-090000-00-00NoNoCurrent