FDA.reportPublic FDA data

ibuprofen

Product NDC
68788-8183
11-digit product format
687888183
Labeler code
68788
Product ID
68788-8183_b6a670e1-9a98-4742-b73c-b61105a07f5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202413
Marketing category
ANDA
Marketing start
2022-04-29
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-8183DDiscontinued by firm2026-08-03
excluded packagepackage68788-818368788-8183-1DDiscontinued by firm2026-08-03
excluded packagepackage68788-818368788-8183-2DDiscontinued by firm2026-08-03
excluded packagepackage68788-818368788-8183-3DDiscontinued by firm2026-08-03
excluded packagepackage68788-818368788-8183-4DDiscontinued by firm2026-08-03
excluded packagepackage68788-818368788-8183-5DDiscontinued by firm2026-08-03
excluded packagepackage68788-818368788-8183-6DDiscontinued by firm2026-08-03
excluded packagepackage68788-818368788-8183-7DDiscontinued by firm2026-08-03
excluded packagepackage68788-818368788-8183-8DDiscontinued by firm2026-08-03
excluded packagepackage68788-818368788-8183-9DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202413-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2016-11-23
A202413-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2016-11-23
A202413-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2016-11-23
A202413-004IBUPROFENIBUPROFEN300MGTABLET / ORAL2024-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202413-001AB
A202413-002AB
A202413-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-23a50c72e98297…
2026-08-01 22:54:322026-06A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-23a50c72e98297…
2026-08-01 22:54:322026-06A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-23a50c72e98297…
2026-08-01 22:54:322026-06A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202413-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202413-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202413-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENREMEDYREPACK INC.2572ed69-d5a7-4513-a202-aca3230e7ec52026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.656658cc-8cf0-42b6-af4f-4e3ab76486252026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.c0156053-add5-4bd5-b89f-f90df2e73be42026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3a38add6-a114-4e18-836c-3bfc727db2312026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENRedpharm Drug5302291e-4816-8495-e063-6394a90a9cc02026-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENREMEDYREPACK INC.404df13d-4ada-4324-9eed-e21f5d5043a42026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENST. MARY'S MEDICAL PARK PHARMACY4e67aef4-c3ac-232a-e063-6394a90a3a852026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENBryant Ranch Prepack886c974c-0d32-4a1b-8f54-40c2c12efa452026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.2e0f74a5-b8f3-fc81-e063-6394a90a647a2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENProficient Rx LPab2f1a30-611b-41b6-9baf-6a82305da8452026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.4b34b58b-2cf7-9aa8-e063-6294a90a06582026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENA-S Medication Solutions0170876a-d8cd-4a2d-8397-db2acdf72ffb2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.70e191ef-8fad-49eb-9850-fceea119e92f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.b84ea215-e61d-4c00-8a34-d47c4080779b2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENCoupler LLC4831785a-cde2-79a2-e063-6294a90a9a402026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENAiPing Pharmaceutical, Inc.3e131710-2579-446e-8076-f602ecea813f2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENChartwell RX, LLC39f2664f-6c0a-4726-85d7-4227530d4a492025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENRedpharm Drug44f278ac-6bf9-6aef-e063-6394a90a0bb62025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENRedpharm Drug44f5743f-8c98-dc4d-e063-6294a90a6dfa2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENRedpharm Drug44f609dd-c868-493f-e063-6294a90a71382025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8183-1EA - Each68788-8183437d6c30-5463-4735-b45d-cc8b33d6a45512022-07-06
68788-8183-2EA - Each68788-818371c79ac2-d4d7-48a2-9282-269f44ba29bf12022-07-06
68788-8183-3EA - Each68788-818301c63b47-58de-4dad-b6f7-2bd828a4553012022-07-06
68788-8183-4EA - Each68788-818314b618ba-b8a3-4449-b9ca-56b2f3b5c0cf12022-07-06
68788-8183-5EA - Each68788-8183155e70c3-5ad6-4313-8a34-3d0726461c7c12022-07-06
68788-8183-6EA - Each68788-81831c1c8d06-43e0-449e-865b-a86eace6ffbf12022-07-06
68788-8183-7EA - Each68788-818349314f3e-3ddf-4062-a3bf-201115c4e39d12022-07-06
68788-8183-8EA - Each68788-8183e5f0d54f-3aca-4080-b18f-36f19ee6705712022-07-06
68788-8183-9EA - Each68788-81830e070542-83a1-48bb-ba6e-8314cd67e85912022-07-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8183-168788818301100 TABLET, FILM COATED in 1 BOTTLE (68788-8183-1) 2022-04-290000-00-00NoNoCurrent
68788-8183-26878881830220 TABLET, FILM COATED in 1 BOTTLE (68788-8183-2) 2022-04-290000-00-00NoNoCurrent
68788-8183-36878881830330 TABLET, FILM COATED in 1 BOTTLE (68788-8183-3) 2022-04-290000-00-00NoNoCurrent
68788-8183-46878881830414 TABLET, FILM COATED in 1 BOTTLE (68788-8183-4) 2022-04-290000-00-00NoNoCurrent
68788-8183-56878881830550 TABLET, FILM COATED in 1 BOTTLE (68788-8183-5) 2022-04-290000-00-00NoNoCurrent
68788-8183-66878881830660 TABLET, FILM COATED in 1 BOTTLE (68788-8183-6) 2022-04-290000-00-00NoNoCurrent
68788-8183-76878881830721 TABLET, FILM COATED in 1 BOTTLE (68788-8183-7) 2022-04-290000-00-00NoNoCurrent
68788-8183-868788818308120 TABLET, FILM COATED in 1 BOTTLE (68788-8183-8) 2022-04-290000-00-00NoNoCurrent
68788-8183-96878881830990 TABLET, FILM COATED in 1 BOTTLE (68788-8183-9) 2022-04-290000-00-00NoNoCurrent