FDA.reportPublic FDA data

Ibuprofen

Product NDC
43063-867
11-digit product format
430630867
Labeler code
43063
Product ID
43063-867_2b4b9e26-13f0-b8c6-e063-6394a90a03b8
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
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
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
IBUPROFEN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197806

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
43063-867-01Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10023
43063-867-10Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1023
43063-867-30Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3023
43063-867-60Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-867-01EA - Each43063-867f2e715d3-a058-4e4e-a499-30079ddce7c412018-09-05
43063-867-04EA - Each43063-8673a7340ed-5bb5-4800-b6d3-53c2f1b5706512020-01-03
43063-867-06EA - Each43063-8677bd85062-64a2-46ce-9079-2b7541d5612b12019-01-24
43063-867-10EA - Each43063-86764fe5ce7-0c44-42c7-9337-fd3a91d8e15712018-10-11
43063-867-15EA - Each43063-86724c9c34b-6fff-4620-a4c9-b4c380443fd012018-08-13
43063-867-20EA - Each43063-86743091803-b8df-4e80-9268-ccbc9d11166b12018-08-13
43063-867-21EA - Each43063-8674fc46601-36fd-4480-be33-727b646c1f1b12018-08-13
43063-867-24EA - Each43063-867856abb9c-68fe-40fc-87b0-87aa6799a93112018-08-13
43063-867-30EA - Each43063-867512727a2-17bc-4841-af3e-16f582d7eea112018-08-13
43063-867-40EA - Each43063-867935ea427-3b8f-4741-8dea-af63dfd2127612018-10-11
43063-867-60EA - Each43063-86720847e38-41a1-4fa2-8313-05c9f8dbc03d12018-08-13
43063-867-82EA - Each43063-867efe67c24-4928-4cb8-8325-647f5277291d12020-04-20
43063-867-90EA - Each43063-867465aa7fa-c8e0-4308-8380-945abf86fc2f12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-867IBUPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 4 package rows20250112_701ee488-c57f-a82c-e053-2991aa0af403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN701ee488-c57f-a82c-e053-2991aa0af40323
197806ibuprofen 600 MG Oral TabletSCD701ee488-c57f-a82c-e053-2991aa0af40323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-867-0143063086701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-01) 2018-07-110000-00-00NoNoCurrent
43063-867-04430630867044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-04) 2019-10-310000-00-00NoNoCurrent
43063-867-06430630867066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-06) 2018-11-160000-00-00NoNoCurrent
43063-867-104306308671010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-10) 2018-09-050000-00-00NoNoCurrent
43063-867-154306308671515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-15) 2018-07-050000-00-00NoNoCurrent
43063-867-204306308672020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-20) 2018-07-050000-00-00NoNoCurrent
43063-867-214306308672121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-21) 2018-07-110000-00-00NoNoCurrent
43063-867-244306308672424 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-24) 2018-07-120000-00-00NoNoCurrent
43063-867-304306308673030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-30) 2023-10-300000-00-00NoNoCurrent
43063-867-404306308674040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-40) 2018-09-050000-00-00NoNoCurrent
43063-867-604306308676060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-60) 2018-07-050000-00-00NoNoCurrent
43063-867-8243063086782500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-82) 2020-02-240000-00-00NoNoCurrent
43063-867-904306308679090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-867-90) 2018-07-110000-00-00NoNoCurrent