IBUPROFEN

Product NDC
50090-5160
Requested package NDC
50090-5160-0
11-digit product format
500905160
Labeler code
50090
Product ID
50090-5160_54a883db-4813-4b74-85c9-a7d132fc61a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090796
Marketing category
ANDA
Marketing start
2015-12-30
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
400 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 packagepackage50090-516050090-5160-0DDiscontinued by firm2026-08-17

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 · 11 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…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090796-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2010-12-21
A090796-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2010-12-21
A090796-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2010-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090796-001AB
A090796-002AB
A090796-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090796-002IBUPROFEN600MGTABLET / ORALAB2010-12-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090796-003IBUPROFEN800MGTABLET / ORALAB2010-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090796-001IBUPROFEN400MGTABLET / ORALAB2010-12-211e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090796-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090796-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090796-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090796-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090796-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090796-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090796-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090796-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090796-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090796-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090796-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090796-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090796-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090796-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090796-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090796-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090796-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090796-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090796-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090796-001AB11e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5160-1EA - Each50090-5160207bb44b-dfe3-4077-ae04-ea77d78498e312022-12-07

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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENREMEDYREPACK INC.a7756b22-73cf-4262-aa8e-0577ddecd03b2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IBUPROFENIBUPROFENSt. Mary's Medical Park Pharmacy950c3ca7-4481-976f-e053-2995a90ad51e2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IBUPROFENIBUPROFENSt. Mary's Medical Park Pharmacy95830141-2439-9d45-e053-2995a90ae0842026-05-01Exact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENREMEDYREPACK INC.a348a959-46bc-4ff6-8936-12866fc34a4b2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENNorthwind Health Company, LLCc20f1f4d-59b3-6bbe-e053-2a95a90abaf12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENNorthwind Health Company, LLCdac07d8f-6b6f-20ab-e053-2a95a90af3ba2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENNorthwind Health Company, LLCda6c72ad-009f-3d7f-e053-2995a90a68e92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENQPharma, Inc.f452d2c3-525f-4933-b146-92351d0ae44f2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.ce5b0429-bbe1-47a4-af5e-0159d3cfd2c32025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IBUPROFENIBUPROFENDirect Rxd88d0544-57a7-4a82-e053-2a95a90a19452025-01-21Exact identifier
application applno (ANDA): 090796
application number: ANDA090796
IBUPROFENIBUPROFENDIRECT RXc3f30813-0848-6e8a-e053-2995a90a3dea2025-01-20Exact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb2025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.701ee488-c57f-a82c-e053-2991aa0af4032025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.9b02607a-6fab-5205-e053-2a95a90afa262025-01-02Exact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCb33caad1-8d40-16f2-e053-2a95a90a1b2d2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCbd1ca7af-d640-23fb-e053-2a95a90a8a982024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCf18b6a0a-e42f-083d-e053-2995a90a40e42024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENTIME CAP LABORATORIES, INCec3e8443-d742-4c25-8516-f0df4ebfccdc2024-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENMARKSANS PHARMA LIMITEDe54209c2-f726-440b-ac60-5a72710d2a9b2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC19b06eaf-0d4c-2b4d-e063-6294a90a2eb92024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090796
application number: ANDA090796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5160-05009051600016 TABLET, FILM COATED in 1 BOTTLE (50090-5160-0) 2020-09-210000-00-00NoNoCurrent