Ibuprofen

Product NDC
42543-964
11-digit product format
425430964
Labeler code
42543
Product ID
42543-964_405918bc-44f0-4096-b11d-7b4ae81bc2f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strides Pharma Inc.
Application
ANDA078329
Marketing category
ANDA
Marketing start
2020-08-21
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

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
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 · 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 UTC2026-02A078329-001IBUPROFEN400MGTABLET / 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078329-002IBUPROFEN600MGTABLET / ORALAB2009-02-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078329-003IBUPROFEN800MGTABLET / ORALAB2009-02-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078329-001IBUPROFEN400MGTABLET / ORALAB2009-02-058072bd15b7f6…

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 UTC2026-02A078329-001AB1011fe1cb6892…
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078329-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078329-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078329-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078329-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078329-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078329-001AB18072bd15b7f6…

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197805Internal RxNorm lookup
197806Internal RxNorm lookup
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
2313f7c3-7291-48c8-b455-7cd41716fdb8Available 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
42543-964-07Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42543-964-07EA - Each42543-964ba0e5855-9a27-4d77-962c-27674039b09012020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42543-964IBUPROFEN TABLET, FILM COATED [STRIDES PHARMA INC.]7Current NDC, Legacy NDC, 1 package rows20250325_2313f7c3-7291-48c8-b455-7cd41716fdb8.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 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.8dba0ed8-feef-23a5-e053-2995a90aaff82026-01-05Boxed 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
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.86577bf3-51c6-88e2-e053-2991aa0ac7412025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078329
application number: ANDA078329
IbuprofenIBUPROFENDirect_Rx40071818-5bf0-095b-e063-6294a90ad58a2025-10-16Boxed 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN3732defa-67c2-4b84-8a84-4bbc27b6cb2415
197806ibuprofen 600 MG Oral TabletPSN3732defa-67c2-4b84-8a84-4bbc27b6cb2415
197807ibuprofen 800 MG Oral TabletPSN3732defa-67c2-4b84-8a84-4bbc27b6cb2415
197805ibuprofen 400 MG Oral TabletSCD3732defa-67c2-4b84-8a84-4bbc27b6cb2415
197806ibuprofen 600 MG Oral TabletSCD3732defa-67c2-4b84-8a84-4bbc27b6cb2415
197807ibuprofen 800 MG Oral TabletSCD3732defa-67c2-4b84-8a84-4bbc27b6cb2415
197807ibuprofen 800 MG Oral TabletPSN689dbbe8-4f85-48fe-8efc-fda81b60d37f14
197807ibuprofen 800 MG Oral TabletSCD689dbbe8-4f85-48fe-8efc-fda81b60d37f14
197807ibuprofen 800 MG Oral TabletPSN7942cc53-1268-4e5f-8db0-f0b3524bb74411
197807ibuprofen 800 MG Oral TabletSCD7942cc53-1268-4e5f-8db0-f0b3524bb74411
197805ibuprofen 400 MG Oral TabletPSN2313f7c3-7291-48c8-b455-7cd41716fdb87
197806ibuprofen 600 MG Oral TabletPSN2313f7c3-7291-48c8-b455-7cd41716fdb87
197807ibuprofen 800 MG Oral TabletPSN2313f7c3-7291-48c8-b455-7cd41716fdb87
197805ibuprofen 400 MG Oral TabletSCD2313f7c3-7291-48c8-b455-7cd41716fdb87
197806ibuprofen 600 MG Oral TabletSCD2313f7c3-7291-48c8-b455-7cd41716fdb87
197807ibuprofen 800 MG Oral TabletSCD2313f7c3-7291-48c8-b455-7cd41716fdb87
197807ibuprofen 800 MG Oral TabletPSNc3b988ee-eff3-4578-e053-2995a90a1fcb1
197807ibuprofen 800 MG Oral TabletPSN1ebf94fb-76b6-4c01-be1b-5750628275451
197807ibuprofen 800 MG Oral TabletSCDc3b988ee-eff3-4578-e053-2995a90a1fcb1
197807ibuprofen 800 MG Oral TabletSCD1ebf94fb-76b6-4c01-be1b-5750628275451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42543-964-0742543096407500 TABLET, FILM COATED in 1 BOTTLE (42543-964-07) 2020-08-210000-00-00NoNoCurrent