ibuprofen

Product NDC
55700-168
11-digit product format
557000168
Labeler code
55700
Product ID
55700-168_40dd9a42-ea48-4c49-8770-ba5d3878a989
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA090796
Marketing category
ANDA
Marketing start
2012-02-22
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-168DDiscontinued by firm2026-08-17
excluded packagepackage55700-16855700-168-00DDiscontinued by firm2026-08-17
excluded packagepackage55700-16855700-168-20DDiscontinued by firm2026-08-17
excluded packagepackage55700-16855700-168-21DDiscontinued by firm2026-08-17
excluded packagepackage55700-16855700-168-30DDiscontinued by firm2026-08-17
excluded packagepackage55700-16855700-168-40DDiscontinued by firm2026-08-17
excluded packagepackage55700-16855700-168-60DDiscontinued by firm2026-08-17
excluded packagepackage55700-16855700-168-90DDiscontinued 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 2 · 104 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-168-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-168-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-168-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-168-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-168-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-168-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-168-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-168-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-168-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-168-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-168-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-168-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-168-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-168-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-168-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-168-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-168-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-168-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-168-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-168-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-168-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-168-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-168-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-168-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-168-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-168-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-168-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-168-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-168-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-168-00cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-168-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-168-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-168-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-168-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-168-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-168-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-168-00cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-168-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-168-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-168-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-168-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-168-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-168-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-168-00302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-168-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-168-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-168-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-168-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-168-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-168-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-168-00ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-168-60ed331223b511…672a5bd82f5f…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-168-00EA - Each55700-16887dc3e1b-abcc-442f-b004-dae5d1c73d6f12016-03-04
55700-168-20EA - Each55700-168f456042a-fc71-456a-8c49-ef6f5e36ac5712016-03-04
55700-168-21EA - Each55700-16871051e8e-da3a-4f61-918d-742111f101b612016-03-04
55700-168-30EA - Each55700-168616a1200-073a-40be-92be-946f4a5a0a7f12016-03-04
55700-168-40EA - Each55700-16851042a46-1a6c-41a5-9e90-9c50df0b860a12016-03-04
55700-168-60EA - Each55700-168ef110ed1-838e-4574-a74b-91effd34678812016-03-04
55700-168-90EA - Each55700-168a0573daf-5354-448e-bc64-a35cdecd474412016-03-04

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