Ibuprofen

Product NDC
50090-2548
Requested package NDC
50090-2548-1
11-digit product format
500902548
Labeler code
50090
Product ID
50090-2548_f0c4785a-b0fb-439c-b323-1fa74881a338
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
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
2026-12-31
Current FDA listing
Yes

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 packagepackage50090-254850090-2548-1DDiscontinued 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091625-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2015-09-15
A091625-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2015-09-15
A091625-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2015-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091625-001AB
A091625-002AB
A091625-003AB

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 UTC2026-02A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-158072bd15b7f6…

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 UTC2026-02A091625-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091625-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091625-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091625-001AB18072bd15b7f6…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-2548-02023-02-07IBUPROFEN Tablets, USP
50090-2548-02023-02-07IBUPROFEN Tablets, USP
50090-2548-12023-02-07IBUPROFEN Tablets, USP
50090-2548-12023-02-07IBUPROFEN Tablets, USP
50090-2548-22023-02-07IBUPROFEN Tablets, USP
50090-2548-22023-02-07IBUPROFEN Tablets, USP
50090-2548-32023-02-07IBUPROFEN Tablets, USP
50090-2548-32023-02-07IBUPROFEN Tablets, USP
50090-2548-42023-02-07IBUPROFEN Tablets, USP
50090-2548-42023-02-07IBUPROFEN Tablets, USP
50090-2548-52023-02-07IBUPROFEN Tablets, USP
50090-2548-52023-02-07IBUPROFEN Tablets, USP
50090-2548-72023-02-07IBUPROFEN Tablets, USP
50090-2548-72023-02-07IBUPROFEN Tablets, USP
50090-2548-82023-02-07IBUPROFEN Tablets, USP
50090-2548-82023-02-07IBUPROFEN Tablets, USP
50090-2548-92023-02-07IBUPROFEN Tablets, USP
50090-2548-92023-02-07IBUPROFEN Tablets, USP
50090-2548-02023-01-30IBUPROFEN Tablets, USP
50090-2548-02023-01-30IBUPROFEN Tablets, USP
50090-2548-12023-01-30IBUPROFEN Tablets, USP
50090-2548-12023-01-30IBUPROFEN Tablets, USP
50090-2548-22023-01-30IBUPROFEN Tablets, USP
50090-2548-22023-01-30IBUPROFEN Tablets, USP
50090-2548-32023-01-30IBUPROFEN Tablets, USP
50090-2548-32023-01-30IBUPROFEN Tablets, USP
50090-2548-42023-01-30IBUPROFEN Tablets, USP
50090-2548-42023-01-30IBUPROFEN Tablets, USP
50090-2548-52023-01-30IBUPROFEN Tablets, USP
50090-2548-52023-01-30IBUPROFEN Tablets, USP
50090-2548-72023-01-30IBUPROFEN Tablets, USP
50090-2548-72023-01-30IBUPROFEN Tablets, USP
50090-2548-82023-01-30IBUPROFEN Tablets, USP
50090-2548-82023-01-30IBUPROFEN Tablets, USP
50090-2548-92023-01-30IBUPROFEN Tablets, USP
50090-2548-92023-01-30IBUPROFEN Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2548-0Ibuprofen10 in 1 BOTTLETABLET, FILM COATED1055
50090-2548-1Ibuprofen15 in 1 BOTTLETABLET, FILM COATED1555
50090-2548-2Ibuprofen30 in 1 BOTTLETABLET, FILM COATED3055
50090-2548-3Ibuprofen45 in 1 BOTTLETABLET, FILM COATED4555
50090-2548-4Ibuprofen60 in 1 BOTTLETABLET, FILM COATED6055
50090-2548-5Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10055
50090-2548-7Ibuprofen21 in 1 BOTTLETABLET, FILM COATED2155
50090-2548-8Ibuprofen12 in 1 BOTTLETABLET, FILM COATED1255
50090-2548-9Ibuprofen40 in 1 BOTTLETABLET, FILM COATED4055

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2548-0EA - Each50090-2548e435607f-4032-4e20-90d3-9fc3b0c3a26712019-03-12
50090-2548-1EA - Each50090-2548fa5111fe-da49-4b28-a85e-5a2e20d7e9aa12018-11-06
50090-2548-2EA - Each50090-25482ba9b2e8-68b0-4c8e-b7e5-a48112b3de3a12018-11-06
50090-2548-3EA - Each50090-2548595709a9-4c95-4260-97a3-ea186a98cae712018-11-06
50090-2548-4EA - Each50090-2548822c441c-f9a8-40a5-befe-fb114ec08e8f12018-11-06
50090-2548-5EA - Each50090-2548232f78e6-c7b3-42fb-b404-f69c5cea014412018-11-06
50090-2548-7EA - Each50090-25486163dabd-1d5d-43cf-94df-44cd55c9e3ad12018-11-06
50090-2548-8EA - Each50090-2548c38b67fb-6732-4635-8ccc-b36509b1272312018-11-06
50090-2548-9EA - Each50090-2548a9696a99-1e42-4b07-8912-9cf87a421ab912019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2548IBUPROFEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]55Current NDC, Legacy NDC, 9 package rows20250510_51de1183-d226-4869-a00a-f6c74e126a39.zip

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.d3a7ebef-f7ab-4b34-b62e-278a8deabf782026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.b81c6495-8b30-41ef-8a0f-4cbfd87f1eb42026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d82026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.57a1bf99-5aaf-432d-86ba-5f0e7cfab1a02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENBryant Ranch Prepackf1c88d74-09b0-4b14-baea-106fbbbc54bf2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.b6a6c940-daf6-4e0e-aefb-35cce87a9a552026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.421156d2-85dc-4680-b2b4-d15b67539e872026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.20078671-536f-4b0b-a079-f90ac186a6702026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.1e6f3ce7-e8a3-40e8-8437-523ef5277b2e2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENUnit Dose Solutions, Inc.5515661b-6373-2191-e063-6294a90a17e02026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENA-S Medication Solutionsb40f39e4-a37c-4039-ae37-210c1c3c62352026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENA-S Medication Solutions51de1183-d226-4869-a00a-f6c74e126a392026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
ndc (package): 50090-2548-1
ndc (product): 50090-2548
ndc11 (package): 50090254801
IbuprofenIBUPROFENA-S Medication Solutions25a94943-9acc-49c8-a4da-7e07bb2c35eb2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENNorthwind Health Company, LLCab80abe6-f7db-479b-e053-2a95a90a90e32026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENAscend Laboratories, LLC9ce036ef-a22d-4fca-9a62-1b10978f7b262026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.560e4e05-21e0-4b2a-ab2f-872b5dbb39012026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENQPharma Incfd8b82a7-96fe-8bf5-e053-6394a90a39352026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENGranules Pharmaceuticals Inc.4aefcb3a-5dc8-b88e-e063-6294a90ac0442026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IBUPROFENIBUOROFENDirect_Rx90b8b80e-ab30-3590-e053-2a95a90a70ef2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENLegacy Pharmaceutical Packaging, LLC5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN51de1183-d226-4869-a00a-f6c74e126a3955
197806ibuprofen 600 MG Oral TabletPSN51de1183-d226-4869-a00a-f6c74e126a3955
197807ibuprofen 800 MG Oral TabletPSN51de1183-d226-4869-a00a-f6c74e126a3955
197805ibuprofen 400 MG Oral TabletSCD51de1183-d226-4869-a00a-f6c74e126a3955
197806ibuprofen 600 MG Oral TabletSCD51de1183-d226-4869-a00a-f6c74e126a3955
197807ibuprofen 800 MG Oral TabletSCD51de1183-d226-4869-a00a-f6c74e126a3955

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2548-15009025480115 TABLET, FILM COATED in 1 BOTTLE (50090-2548-1) 2016-12-080000-00-00NoNoCurrent