Ibuprofen

Product NDC
43063-845
11-digit product format
430630845
Labeler code
43063
Product ID
43063-845_e5f98b8a-a74b-208a-e053-2a95a90a359e
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
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
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
43063-845-01EA - Each43063-84505e238f0-ac5c-44ce-963f-0e1d123f183912018-05-09
43063-845-04EA - Each43063-845c692bd67-86ba-42b0-8588-fffa95b54f9212018-05-09
43063-845-10EA - Each43063-8451e3ff827-05d4-4304-b9f3-da9b83ea7aa012018-05-09
43063-845-15EA - Each43063-845724e43ef-c3a5-47d3-904b-e6f666db2d9412018-07-03
43063-845-30EA - Each43063-8453dbff626-2457-44a0-862c-a2f2dd97d1dd12018-05-09
43063-845-40EA - Each43063-84594d6c28b-75dd-47f6-a608-64f3fe74dcaf12018-05-09
43063-845-90EA - Each43063-845518968f3-6bf3-4a48-b5c1-46cf3f22709112018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-845IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]19Legacy NDC20250309_5118d684-2a64-420d-b74e-0fe7c5533fdb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-845-0143063084501100 TABLET in 1 BOTTLE, PLASTIC (43063-845-01) 100 tablet2018-04-240000-00-00NoNoCurrent
43063-845-04430630845044 TABLET in 1 BOTTLE, PLASTIC (43063-845-04) 4 tablet2018-04-240000-00-00NoNoCurrent
43063-845-104306308451010 TABLET in 1 BOTTLE, PLASTIC (43063-845-10) 10 tablet2018-04-240000-00-00NoNoCurrent
43063-845-154306308451515 TABLET in 1 BOTTLE, PLASTIC (43063-845-15) 15 tablet2018-05-310000-00-00NoNoCurrent
43063-845-304306308453030 TABLET in 1 BOTTLE, PLASTIC (43063-845-30) 30 tablet2018-04-100000-00-00NoNoCurrent
43063-845-404306308454040 TABLET in 1 BOTTLE, PLASTIC (43063-845-40) 40 tablet2018-04-100000-00-00NoNoCurrent
43063-845-904306308459090 TABLET in 1 BOTTLE, PLASTIC (43063-845-90) 90 tablet2018-04-240000-00-00NoNoCurrent