Ibuprofen

Product NDC
43063-013
Requested package NDC
43063-013-04
11-digit product format
430630013
Labeler code
43063
Product ID
43063-013_c831cfc8-c143-9da1-e053-2a95a90ad23b
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
800 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43063-01343063-013-04DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078558-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2007-06-18
A078558-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2007-06-18
A078558-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2007-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078558-001AB
A078558-002AB
A078558-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078558-002IBUPROFEN600MGTABLET / ORALAB2007-06-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078558-003IBUPROFEN800MGTABLET / ORALAB2007-06-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078558-001IBUPROFEN400MGTABLET / ORALAB2007-06-188072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078558-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078558-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078558-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078558-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078558-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078558-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078558-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078558-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078558-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078558-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078558-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078558-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078558-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078558-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078558-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078558-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078558-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078558-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078558-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078558-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078558-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078558-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078558-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078558-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078558-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078558-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078558-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078558-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078558-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078558-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078558-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078558-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078558-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078558-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078558-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078558-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078558-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078558-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078558-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078558-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-013-04EA - Each43063-0132b564a62-8822-40fa-bc9e-ab80b487eb2112013-03-03
43063-013-06EA - Each43063-0138520d2de-5a5b-4afd-aa77-33440bd8710712013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]5

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENAmneal Pharmaceuticals LLC17577b3b-e755-45d1-8b53-775d058578b22026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENCardinal Health 107, LLC0387bfaa-daca-48ec-b718-0216a848c16a2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENPHOENIX RX LLC40202c76-4275-88fd-e063-6394a90a07b22025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENAmerican Health Packaginge080f7da-a506-4c04-a227-c1be77234f012025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC334e40f3-6da4-ecbe-e063-6294a90a35bf2025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.fc871659-ce41-1be6-e053-6294a90aa5e42025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCaf9af7f4-6314-6217-e053-2995a90a5a0f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLCfaebc392-0fd9-4c71-8471-beba10dda0222024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENBoswell Pharmacy Services LLC d/b/a BPS Wholesale1a02fa34-b5ae-7183-e063-6294a90a3ae42024-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENBryant Ranch Prepacke90c573d-eb0f-45a5-94d1-efdd3d2b7a112024-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENA-S Medication Solutionsfa99f5ec-0306-473b-827f-86cd0a7978ec2023-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENProficient Rx LPe4bb22bb-6df6-4016-a023-0b454df9fb0b2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558
IbuprofenIBUPROFENProficient Rx LPe23eb275-ce0c-40ec-b809-a48c5e46c7ec2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078558
application number: ANDA078558

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-013-04430630013044 TABLET in 1 BOTTLE, PLASTIC (43063-013-04) 4 tablet2013-02-200000-00-00NoNoCurrent