FDA.reportPublic FDA data

ibuprofen

Product NDC
0904-6747
11-digit product format
009046747
Labeler code
0904
Product ID
0904-6747_dddfc800-cfd3-42d4-82e1-04414822fbfc
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA072096
Marketing category
ANDA
Marketing start
2018-09-20
Substance
IBUPROFEN
Active strength
200 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
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
0904-6747-24ibuprofen24 in 1 BOTTLETABLET, FILM COATED245
0904-6747-24ibuprofen1 in 1 CARTONTABLET, FILM COATED15
0904-6747-40ibuprofen500 in 1 BOTTLETABLET, FILM COATED5005
0904-6747-51ibuprofen1 in 1 CARTONTABLET, FILM COATED15
0904-6747-51ibuprofen50 in 1 BOTTLETABLET, FILM COATED505
0904-6747-59ibuprofen100 in 1 BOTTLETABLET, FILM COATED1005
0904-6747-59ibuprofen1 in 1 CARTONTABLET, FILM COATED15
0904-6747-70ibuprofen1 in 1 CARTONTABLET, FILM COATED15
0904-6747-70ibuprofen250 in 1 BOTTLETABLET, FILM COATED2505
0904-6747-80ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6747-24EA - Each0904-67479e7eaa4f-cbdc-4368-8d75-7b4cbc1cc0ec12019-07-02
0904-6747-40EA - Each0904-6747f34c2638-7fab-4b82-a2a3-f0cb6ef07d3612019-07-02
0904-6747-51EA - Each0904-6747ba8c2cec-d246-4677-82d0-66ba6a09374812019-04-11
0904-6747-59EA - Each0904-67478bd44971-5c1b-431e-89db-5a4984d3dcac12019-09-05
0904-6747-70EA - Each0904-6747a8462561-a70c-4156-987e-8d0147e6aba212019-07-02
0904-6747-80EA - Each0904-6747b1ae7f17-0c46-4608-a842-f574b8f6e24f12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6747IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 10 package rows20250410_14f43c32-0895-4ef2-aa54-52b952d058fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN22cb2ccc-ba4d-4069-8334-f886f0e3e802103
310965ibuprofen 200 MG Oral TabletSCD22cb2ccc-ba4d-4069-8334-f886f0e3e802103
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY22cb2ccc-ba4d-4069-8334-f886f0e3e802103
310965ibuprofen 200 MG Oral TabletPSN96bff700-bca3-4b94-b8a2-379102721db810
310965ibuprofen 200 MG Oral TabletSCD96bff700-bca3-4b94-b8a2-379102721db810
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY96bff700-bca3-4b94-b8a2-379102721db810
310965ibuprofen 200 MG Oral TabletPSN504c7e5d-e721-4df8-865b-8ea17559831d9
310965ibuprofen 200 MG Oral TabletSCD504c7e5d-e721-4df8-865b-8ea17559831d9
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY504c7e5d-e721-4df8-865b-8ea17559831d9
310965ibuprofen 200 MG Oral TabletPSN14f43c32-0895-4ef2-aa54-52b952d058fd5
310965ibuprofen 200 MG Oral TabletSCD14f43c32-0895-4ef2-aa54-52b952d058fd5
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY14f43c32-0895-4ef2-aa54-52b952d058fd5
310965ibuprofen 200 MG Oral TabletPSN798d33b0-5d7a-4445-8a51-2a3d336f744a4
310965ibuprofen 200 MG Oral TabletPSNda6c2802-5d15-dbcb-e053-2a95a90a25614
310965ibuprofen 200 MG Oral TabletPSNcadceab8-7f83-4698-e053-2a95a90ae3c54
310965ibuprofen 200 MG Oral TabletSCDda6c2802-5d15-dbcb-e053-2a95a90a25614
310965ibuprofen 200 MG Oral TabletSCD798d33b0-5d7a-4445-8a51-2a3d336f744a4
310965ibuprofen 200 MG Oral TabletSCDcadceab8-7f83-4698-e053-2a95a90ae3c54
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYda6c2802-5d15-dbcb-e053-2a95a90a25614
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY798d33b0-5d7a-4445-8a51-2a3d336f744a4
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYcadceab8-7f83-4698-e053-2a95a90ae3c54
310965ibuprofen 200 MG Oral TabletPSNec578861-5a50-5362-e053-2995a90ab54a2
310965ibuprofen 200 MG Oral TabletSCDec578861-5a50-5362-e053-2995a90ab54a2
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYec578861-5a50-5362-e053-2995a90ab54a2
310965ibuprofen 200 MG Oral TabletPSN463ea713-6b27-b00b-e063-6394a90a86461
310965ibuprofen 200 MG Oral TabletSCD463ea713-6b27-b00b-e063-6394a90a86461
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY463ea713-6b27-b00b-e063-6394a90a86461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6747-24009046747241 BOTTLE in 1 CARTON (0904-6747-24) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-09-200000-00-00NoNoCurrent
0904-6747-4000904674740500 TABLET, FILM COATED in 1 BOTTLE (0904-6747-40) 2018-09-200000-00-00NoNoCurrent
0904-6747-51009046747511 BOTTLE in 1 CARTON (0904-6747-51) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-09-200000-00-00NoNoCurrent
0904-6747-59009046747591 BOTTLE in 1 CARTON (0904-6747-59) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-09-200000-00-00NoNoCurrent
0904-6747-70009046747701 BOTTLE in 1 CARTON (0904-6747-70) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-09-200000-00-00NoNoCurrent
0904-6747-80009046747801000 TABLET, FILM COATED in 1 BOTTLE (0904-6747-80) 2018-09-200000-00-00NoNoCurrent