FDA.reportPublic FDA data

Ibuprofen

Product NDC
43063-872
11-digit product format
430630872
Labeler code
43063
Product ID
43063-872_303d4f9d-cb3f-1bfa-e063-6294a90a16aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090796
Marketing category
ANDA
Marketing start
2015-12-30
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
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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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
43063-872-06Ibuprofen6 in 1 BOTTLE, PLASTICTABLET, FILM COATED621
43063-872-10Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1021
43063-872-20Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2021
43063-872-30Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3021
43063-872-40Ibuprofen40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4021
43063-872-82Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50021
43063-872-90Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-872-06EA - Each43063-87278bdf8ca-b683-47e3-a092-3401efc0719912019-03-12
43063-872-10EA - Each43063-872d60f015d-9997-4f45-9f5f-8e2bfee787e012019-06-19
43063-872-20EA - Each43063-87282acd90c-f40c-4250-ab6d-e9463ffb476e12018-09-05
43063-872-30EA - Each43063-872e4388c70-d933-4ba0-b142-70716d669bc412018-09-05
43063-872-40EA - Each43063-872ceafaa57-8e7d-4ba1-9496-b9be138be07312018-10-11
43063-872-82EA - Each43063-872545d393e-1335-40d3-a156-c1d006c6282212020-04-20
43063-872-90EA - Each43063-872efa38677-a1f5-46ca-b591-8873415340e412019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-872IBUPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 7 package rows20250316_ce5b0429-bbe1-47a4-af5e-0159d3cfd2c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNce5b0429-bbe1-47a4-af5e-0159d3cfd2c321
197805ibuprofen 400 MG Oral TabletSCDce5b0429-bbe1-47a4-af5e-0159d3cfd2c321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-872-06430630872066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-06) 2019-01-250000-00-00NoNoCurrent
43063-872-104306308721010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-10) 2019-04-290000-00-00NoNoCurrent
43063-872-204306308722020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-20) 2018-08-070000-00-00NoNoCurrent
43063-872-304306308723030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-30) 2018-08-070000-00-00NoNoCurrent
43063-872-404306308724040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-40) 2018-08-070000-00-00NoNoCurrent
43063-872-8243063087282500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-82) 2019-03-020000-00-00NoNoCurrent
43063-872-904306308729090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-872-90) 2019-04-260000-00-00NoNoCurrent