IBU

Product NDC
71610-275
11-digit product format
716100275
Labeler code
71610
Product ID
71610-275_8205e32a-d524-488b-b591-bc4d697896c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075682
Marketing category
ANDA
Marketing start
2008-11-20
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 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
A075682-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2001-11-14
A075682-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2001-11-14
A075682-003IBUPROFENIBUPROFEN800MGTABLET / ORALABRS2001-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075682-001AB
A075682-002AB
A075682-003AB

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 UTC2026-02A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075682-002IBUPROFEN600MGTABLET / ORALAB2001-11-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075682-003IBUPROFEN800MGTABLET / ORALABRS2001-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075682-001IBUPROFEN400MGTABLET / ORALAB2001-11-148072bd15b7f6…

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 UTC2026-02A075682-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075682-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075682-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075682-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075682-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075682-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075682-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075682-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075682-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075682-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075682-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075682-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075682-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075682-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075682-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075682-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075682-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075682-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075682-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075682-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075682-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075682-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075682-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075682-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075682-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075682-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
IBU
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ffec2f44-1144-4729-b43a-1db40ea6a8d3Available 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
71610-275-60IBU90 in 1 BOTTLETABLET901
71610-275-80IBU180 in 1 BOTTLETABLET1801
71610-275-92IBU270 in 1 BOTTLETABLET2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-275-60EA - Each71610-275457c1f0f-5b79-4203-977e-6dad11a174a912019-06-19
71610-275-80EA - Each71610-275d23dd9d3-9a1d-4929-b083-dd54a36fcc9512019-06-19
71610-275-92EA - Each71610-2755835bad4-0b68-4277-8943-af8f7db9038712019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-275IBU (IBUPROFEN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20190516_ffec2f44-1144-4729-b43a-1db40ea6a8d3.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENPreferred Pharmaceuticals, Inc.72ec2491-924d-460f-9510-62d624d54b592026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IBUIBUPROFENGolden State Medical Supply, Inc.bbf4821d-f9fc-9f6e-e053-2a95a90a52532026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC4522b794-5c93-44cd-e063-6394a90ab39a2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC45223597-0ea8-b275-e063-6394a90a84122025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC4522cb9e-4999-c455-e063-6294a90a294f2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IBUIBUPROFENProficient Rx LPa7098fa1-b5ae-485e-ada9-64154f81fb6a2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IbuprofenIBUPROFENGolden State Medical Supply, Inc.3ff501eb-5ae3-8824-e063-6394a90ac58e2025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IbuprofenIBUPROFENMajor Pharmaceuticalsba86e936-ef72-43e5-aebf-f2c788fe22662025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IbuprofenIBUPROFENCardinal Health 107, LLC8ea0e303-3967-4d71-8255-ac42a841ce282025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IBUIBUPROFENDr. Reddy's Laboratories Limited24731405-219c-79b4-ecf0-7d5fbfda94ba2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IBUIBURedPharm Drug, Inc.4db219dc-ea48-490c-e054-00144ff88e882025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31e6005b-492e-7936-e063-6394a90ad8012025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31e6ac7a-fa3e-4dd4-e063-6294a90a29af2025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IbuprofenIBUPROFENBryant Ranch Prepack7650f84b-92f2-4065-8ef2-f5de5bd7002b2024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IBUIBUPROFENNuCare Pharmaceuticals,Inc.593d9870-0213-75e6-e053-2991aa0a0eff2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IBUIBUPROFENNuCare Pharmaceuticals Inc.575c275c-3e1a-0572-e053-2991aa0adabd2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IBUIBUPROFENNuCare Pharmaceuticals,Inc.678e2d16-33f3-67a7-e053-2991aa0a11322024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IBUIBUPROFENProficient Rx LPea6f626d-cda3-46e2-9ac9-4e72204cb7262023-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IBUIBUPROFENAphena Pharma Solutions - Tennessee, LLCb0f03994-b744-4d66-95b7-8c86217882bc2021-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682
IBUIBUPROFENAphena Pharma Solutions - Tennessee, LLC3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd2021-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075682
application number: ANDA075682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-275-607161002756090 TABLET in 1 BOTTLE (71610-275-60) 90 tablet2019-05-080000-00-00NoNoCurrent
71610-275-8071610027580180 TABLET in 1 BOTTLE (71610-275-80) 180 tablet2019-05-080000-00-00NoNoCurrent
71610-275-9271610027592270 TABLET in 1 BOTTLE (71610-275-92) 270 tablet2019-05-080000-00-00NoNoCurrent