Ibuprofen

Product NDC
43063-843
11-digit product format
430630843
Labeler code
43063
Product ID
43063-843_e5f96450-f61e-ceb1-e053-2a95a90ab0c8
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
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
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-843IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]16Legacy NDC20250309_c0fa1871-05d5-49a2-8695-f209652a3df8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-843-06430630843066 TABLET in 1 BOTTLE, PLASTIC (43063-843-06) 6 tablet2018-05-030000-00-00NoNoCurrent
43063-843-204306308432020 TABLET in 1 BOTTLE, PLASTIC (43063-843-20) 20 tablet2018-04-050000-00-00NoNoCurrent
43063-843-304306308433030 TABLET in 1 BOTTLE, PLASTIC (43063-843-30) 30 tablet2018-04-130000-00-00NoNoCurrent
43063-843-404306308434040 TABLET in 1 BOTTLE, PLASTIC (43063-843-40) 40 tablet2018-04-050000-00-00NoNoCurrent