Ibuprofen

Product NDC
80425-0537
11-digit product format
804250537
Labeler code
80425
Product ID
80425-0537_3b9fdc58-687a-4e47-e063-6294a90a0189
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA078329
Marketing category
ANDA
Marketing start
2025-08-05
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

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

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
A078329-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2009-02-05
A078329-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2009-02-05
A078329-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2009-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078329-001AB
A078329-002AB
A078329-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-0584e616aacf4f…
2026-09-14 22:38:342026-08A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-0584e616aacf4f…
2026-09-14 22:38:342026-08A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-0584e616aacf4f…
2026-08-18 06:07:402026-07A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-05301d65b070ca…

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 22:38:342026-08A078329-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078329-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078329-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078329-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078329-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078329-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078329-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078329-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078329-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078329-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078329-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078329-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078329-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078329-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078329-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078329-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078329-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078329-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078329-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078329-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078329-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078329-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078329-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078329-001AB1301d65b070ca…

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
IBUPROFEN800 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
197807Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b9fdc48-c071-4e2c-e063-6294a90a679fAvailable 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
80425-0537-1Ibuprofen30 in 1 BOTTLETABLET301
80425-0537-2Ibuprofen60 in 1 BOTTLETABLET601
80425-0537-3Ibuprofen90 in 1 BOTTLETABLET901
80425-0537-4Ibuprofen100 in 1 BOTTLETABLET1001
80425-0537-5Ibuprofen120 in 1 BOTTLETABLET1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0537-1EA - Each80425-05370d3ddd1a-ad3e-45e0-bac8-e8f2403260d012025-09-12
80425-0537-2EA - Each80425-05370ccd6a28-f2ce-4aef-a90d-c9c0244e326412025-09-12
80425-0537-3EA - Each80425-05375c922582-9d59-439c-8a7e-769044feeee012025-09-12
80425-0537-4EA - Each80425-05371e41c6a0-1b83-4a1c-af36-0283d023b4cb12025-09-12
80425-0537-5EA - Each80425-0537da09e691-70e6-4367-a878-0675e95fa54312025-09-12

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 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENDirect_Rx40071818-5bf0-095b-e063-6294a90ad58a2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENREMEDYREPACK INC.99730c4a-d2ee-46f5-91f4-a15cbaace40d2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENSt. Mary's Medical Park Pharmacy88dd304f-1c64-08e3-e053-2a95a90a596f2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENST. MARY'S MEDICAL PARK PHARMACY88dda062-2b9c-3632-e053-2a95a90a14312026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.60c731c6-4dc4-490a-8469-0b7e58e563a12026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENBryant Ranch Prepack1ebf94fb-76b6-4c01-be1b-5750628275452026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENBryant Ranch Prepack0550fa2f-f25e-4abb-b10e-a3d05bdb32172026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENBryant Ranch Prepackc38a03fa-6b9a-4737-a848-063ca5c580b92026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENStrides Pharma Science Limiteda266a3c6-932f-476f-ae93-48a785c922862025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.06710aef-2631-4925-8e9e-33bae84b59122025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC3b9fdc48-c071-4e2c-e063-6294a90a679f2025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
ndc (product): 80425-0537
IbuprofenIBUPROFENAsclemed USA, Inc.d7ed42c4-371c-4a54-ab15-0630656f04272025-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENNCS HealthCare of KY, LLC dba Vangard Labsab11e142-9e11-4ce4-9671-7e4fe53ffe922025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENNCS HealthCare of KY, LLC dba Vangard Labsf1842893-7a34-4f77-8231-55fb0c98b22b2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3732defa-67c2-4b84-8a84-4bbc27b6cb242025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.689dbbe8-4f85-48fe-8efc-fda81b60d37f2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.09621787-9a5c-4abf-9ccd-d6f8d581738f2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.42b92fd7-468c-4fb8-9ff0-31296735df4c2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.7942cc53-1268-4e5f-8db0-f0b3524bb7442025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENProficient Rx LPc5eaa3a9-5aa8-46b0-8cec-639bfb3274752025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN3b9fdc48-c071-4e2c-e063-6294a90a679f1
197807ibuprofen 800 MG Oral TabletSCD3b9fdc48-c071-4e2c-e063-6294a90a679f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0537-18042505370130 TABLET in 1 BOTTLE (80425-0537-1) 30 tablet2025-08-05NoNoCurrent
80425-0537-28042505370260 TABLET in 1 BOTTLE (80425-0537-2) 60 tablet2025-08-05NoNoCurrent
80425-0537-38042505370390 TABLET in 1 BOTTLE (80425-0537-3) 90 tablet2025-08-05NoNoCurrent
80425-0537-480425053704100 TABLET in 1 BOTTLE (80425-0537-4) 100 tablet2025-08-05NoNoCurrent
80425-0537-580425053705120 TABLET in 1 BOTTLE (80425-0537-5) 120 tablet2025-08-05NoNoCurrent