FDA.reportPublic FDA data

Ibuprofen

Product NDC
71335-1207
11-digit product format
713351207
Labeler code
71335
Product ID
71335-1207_b4248cc8-1b23-44c3-8815-dac97370b01d
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
600 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
IBUPROFEN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197806

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
71335-1207-0Ibuprofen21 in 1 BOTTLETABLET, FILM COATED211004
71335-1207-1Ibuprofen20 in 1 BOTTLETABLET, FILM COATED201004
71335-1207-2Ibuprofen15 in 1 BOTTLETABLET, FILM COATED151004
71335-1207-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED301004
71335-1207-4Ibuprofen40 in 1 BOTTLETABLET, FILM COATED401004
71335-1207-5Ibuprofen60 in 1 BOTTLETABLET, FILM COATED601004
71335-1207-6Ibuprofen90 in 1 BOTTLETABLET, FILM COATED901004
71335-1207-7Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1201004
71335-1207-8Ibuprofen50 in 1 BOTTLETABLET, FILM COATED501004
71335-1207-9Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1001004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1207-0EA - Each71335-1207e269451a-be5d-4b4f-a2a1-907125d74ecc12021-12-08
71335-1207-1EA - Each71335-12078712a2ad-4851-4b66-b7fe-d150b75af96912021-12-08
71335-1207-3EA - Each71335-1207c6e67a38-6d93-49ab-970c-03b61c2b3b1c12019-10-07
71335-1207-4EA - Each71335-120755dcd3f2-b6b8-4638-b78c-4a9fe2f05f8c12021-12-08
71335-1207-5EA - Each71335-12075e92fe49-c565-4c62-abb1-d931703e9e9912021-12-08
71335-1207-6EA - Each71335-12075bef2de2-f73e-4856-ac9e-94c07dc4973712021-12-08
71335-1207-7EA - Each71335-120788d668e4-6c0c-4e76-89a1-406f2897542312021-12-08
71335-1207-8EA - Each71335-1207cc314ff0-8277-486f-8564-31b54b2ecf4412021-12-08
71335-1207-9EA - Each71335-12072d75781f-4e36-4012-92de-1a74c91f9c9012021-12-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN0550fa2f-f25e-4abb-b10e-a3d05bdb32171004
197806ibuprofen 600 MG Oral TabletSCD0550fa2f-f25e-4abb-b10e-a3d05bdb32171004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1207-07133512070021 TABLET, FILM COATED in 1 BOTTLE (71335-1207-0) 2019-10-300000-00-00NoNoCurrent
71335-1207-17133512070120 TABLET, FILM COATED in 1 BOTTLE (71335-1207-1) 2019-12-260000-00-00NoNoCurrent
71335-1207-27133512070215 TABLET, FILM COATED in 1 BOTTLE (71335-1207-2) 2020-09-040000-00-00NoNoCurrent
71335-1207-37133512070330 TABLET, FILM COATED in 1 BOTTLE (71335-1207-3) 2019-05-060000-00-00NoNoCurrent
71335-1207-47133512070440 TABLET, FILM COATED in 1 BOTTLE (71335-1207-4) 2020-07-290000-00-00NoNoCurrent
71335-1207-57133512070560 TABLET, FILM COATED in 1 BOTTLE (71335-1207-5) 2019-04-150000-00-00NoNoCurrent
71335-1207-67133512070690 TABLET, FILM COATED in 1 BOTTLE (71335-1207-6) 2019-11-200000-00-00NoNoCurrent
71335-1207-771335120707120 TABLET, FILM COATED in 1 BOTTLE (71335-1207-7) 2020-09-040000-00-00NoNoCurrent
71335-1207-87133512070850 TABLET, FILM COATED in 1 BOTTLE (71335-1207-8) 2020-09-040000-00-00NoNoCurrent
71335-1207-971335120709100 TABLET, FILM COATED in 1 BOTTLE (71335-1207-9) 2020-01-220000-00-00NoNoCurrent