Ibuprofen

Product NDC
80425-0553
11-digit product format
804250553
Labeler code
80425
Product ID
80425-0553_41351cd8-bc54-3906-e063-6294a90a3b83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA202413
Marketing category
ANDA
Marketing start
2025-10-15
Substance
IBUPROFEN
Active strength
600 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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.

Product history page 1 of 4 · 143 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-2384e616aacf4f…
2026-09-14 22:38:342026-08A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-2384e616aacf4f…
2026-09-14 22:38:342026-08A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-2384e616aacf4f…
2026-09-14 22:38:342026-08A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-0584e616aacf4f…
2026-08-18 06:07:402026-07A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-055bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202413-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202413-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202413-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A202413-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202413-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202413-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202413-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202413-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202413-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202413-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202413-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202413-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202413-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202413-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202413-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202413-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202413-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202413-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202413-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202413-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202413-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202413-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197806Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41351cc0-5ec6-2f4d-e063-6294a90a733aAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0553-1Ibuprofen30 in 1 BOTTLETABLET, FILM COATED301
80425-0553-2Ibuprofen60 in 1 BOTTLETABLET, FILM COATED601
80425-0553-3Ibuprofen90 in 1 BOTTLETABLET, FILM COATED901
80425-0553-4Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0553-1EA - Each80425-05534542d91c-36ac-46b2-93c7-81d6ada13b4512025-11-13
80425-0553-2EA - Each80425-055312583d8a-08c2-4981-9f98-493e07c33b5d12025-11-13
80425-0553-3EA - Each80425-05534778d495-0218-4cc3-83ca-694a167ccbb312025-11-13
80425-0553-4EA - Each80425-05534f496210-1268-4ad4-9cec-702329d63d3f12025-11-13

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 2 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENRedpharm Drug44f609dd-c868-493f-e063-6294a90a71382025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENA-S Medication Solutions71b5b2a2-397e-4dcb-b0c7-ef08df4337e02025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENA-S Medication Solutions47711610-6577-4805-a2ce-cf9b7cbfa8122025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC41351cc0-5ec6-2f4d-e063-6294a90a733a2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
ndc (product): 80425-0553
IbuprofenIBUPROFENCoupler LLC410f7320-4caa-8f88-e063-6394a90acf932025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.a85080d7-50b4-461b-9d77-d6fbab971c032025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPHOENIX RX LLC3b17587e-b609-42a9-e063-6294a90ab1f82025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENSOLA Pharmaceuticals, LLC44fb0842-c34e-477e-96df-350cd5d6800e2025-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC388e68dc-1822-f375-e063-6294a90a3d412025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.2c3f8149-9b77-54cd-e063-6394a90a847e2025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.3520deb7-5e45-3d0f-e063-6394a90ab44b2025-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC34673d3b-41cd-f4c9-e063-6394a90a85102025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC3467b45b-c432-2923-e063-6394a90a10442025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENBrisk Pharmaceuticals2dcbe4bb-fb24-e827-e063-6394a90acf9f2025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENA-S Medication Solutions2d0c2d35-c212-4daa-b2c4-b407ca0b16ad2024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENA-S Medication Solutions2b470e48-c23c-4f5c-916a-d38d8518896b2024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENA-S Medication Solutionsdf0e55d0-617c-4084-984f-ece2f640e7152024-10-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENA-S Medication Solutionsb0917020-f0ec-4d07-8fbf-c1eb909f466b2024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENA-S Medication Solutionsb365be3a-91ad-46bf-a949-103c81f2359a2024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENWestminster Pharmaceuticals, LLCeeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d2024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN41351cc0-5ec6-2f4d-e063-6294a90a733a1
197806ibuprofen 600 MG Oral TabletSCD41351cc0-5ec6-2f4d-e063-6294a90a733a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0553-18042505530130 TABLET, FILM COATED in 1 BOTTLE (80425-0553-1) 2025-10-15NoNoCurrent
80425-0553-28042505530260 TABLET, FILM COATED in 1 BOTTLE (80425-0553-2) 2025-10-15NoNoCurrent
80425-0553-38042505530390 TABLET, FILM COATED in 1 BOTTLE (80425-0553-3) 2025-10-15NoNoCurrent
80425-0553-480425055304100 TABLET, FILM COATED in 1 BOTTLE (80425-0553-4) 2025-10-15NoNoCurrent