FDA.reportPublic FDA data

Ibuprofen

Product NDC
43063-847
11-digit product format
430630847
Labeler code
43063
Product ID
43063-847_e5f9b426-e4f4-a634-e053-2a95a90aa859
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-847-10EA - Each43063-847d85430d7-41d6-4800-847e-62c06c9b5a5c12018-05-09
43063-847-15EA - Each43063-84767bfbf88-66fa-467c-b78f-d0d5617ea37b12018-05-09
43063-847-20EA - Each43063-847698aad2d-df14-4cb5-a1e2-5182cce60e8112018-05-09
43063-847-24EA - Each43063-8479fe14122-9b65-4bae-830d-5c2cfe86a29c12018-05-09
43063-847-30EA - Each43063-8475efbc5ea-c7e3-48cb-b93c-1327fbb80a1a12018-05-09
43063-847-60EA - Each43063-847fae28664-587a-49a8-b910-cd1e28bad71212018-05-09
43063-847-90EA - Each43063-84713eff8b6-7ad6-4226-af14-af277257420d12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-847IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]17Legacy NDC20250309_92dd73eb-476e-4545-95d1-412f7c555498.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-847-104306308471010 TABLET in 1 BOTTLE, PLASTIC (43063-847-10) 10 tablet2018-04-240000-00-00NoNoCurrent
43063-847-154306308471515 TABLET in 1 BOTTLE, PLASTIC (43063-847-15) 15 tablet2018-04-240000-00-00NoNoCurrent
43063-847-204306308472020 TABLET in 1 BOTTLE, PLASTIC (43063-847-20) 20 tablet2018-04-180000-00-00NoNoCurrent
43063-847-244306308472424 TABLET in 1 BOTTLE, PLASTIC (43063-847-24) 24 tablet2018-04-240000-00-00NoNoCurrent
43063-847-304306308473030 TABLET in 1 BOTTLE, PLASTIC (43063-847-30) 30 tablet2018-04-120000-00-00NoNoCurrent
43063-847-604306308476060 TABLET in 1 BOTTLE, PLASTIC (43063-847-60) 60 tablet2018-04-160000-00-00NoNoCurrent
43063-847-904306308479090 TABLET in 1 BOTTLE, PLASTIC (43063-847-90) 90 tablet2018-04-240000-00-00NoNoCurrent