FDA.reportPublic FDA data

Ibuprofen

Product NDC
72789-565
11-digit product format
727890565
Labeler code
72789
Product ID
72789-565_5a702e13-8dc1-4504-e063-6394a90a6234
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA202413
Marketing category
ANDA
Marketing start
2025-12-15
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
2027-12-31
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
2027-12-31

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
3a38add6-a114-4e18-836c-3bfc727db231Available 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
72789-565-30Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3021
72789-565-60Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6021
72789-565-82Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50021
72789-565-86Ibuprofen360 in 1 BOTTLE, PLASTICTABLET, FILM COATED36021
72789-565-90Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9021
72789-565-93Ibuprofen180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18021
72789-565-94Ibuprofen270 in 1 BOTTLE, PLASTICTABLET, FILM COATED27021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-565-30EA - Each72789-56539a4e6e6-7e87-420b-961b-327dc2e5453212026-05-22
72789-565-60EA - Each72789-56558701152-7806-416c-9eeb-d3ba0049147f12026-05-22
72789-565-82EA - Each72789-565b636d39d-620f-4ad8-958c-d28e6eb75c2c12026-05-22
72789-565-86EA - Each72789-56569e39035-3000-44cf-aebf-da2680872ab112026-05-22
72789-565-90EA - Each72789-56539cc4ef9-68a0-4eed-8411-4f23afea68bb12026-05-22
72789-565-93EA - Each72789-565a92ac29c-c68d-4c3a-803a-719ba2b35e4d12026-05-22
72789-565-94EA - Each72789-5656ecfc3dd-7725-411e-a528-fe408722c1b812026-05-22

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 3 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENA-S Medication Solutions0ce79e85-0b8b-436e-b895-ea5c02eaf4ba2024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENA-S Medication Solutions8d41cc03-dec6-4949-b7c1-7deb2897e2c42024-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENProficient Rx LP43ac478c-43db-4136-8fee-4a43b09681e52024-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENAsclemed USA, Inc.ca81671d-1ea8-4c67-802f-adb3a2f087cc2024-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.214e3b3e-87b9-9ff5-e063-6394a90ae96a2024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN3a38add6-a114-4e18-836c-3bfc727db23121
197807ibuprofen 800 MG Oral TabletSCD3a38add6-a114-4e18-836c-3bfc727db23121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-565-107278905651015 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-10) 2026-08-21NoNoCurrent
72789-565-157278905651515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-15) 2026-06-05NoNoCurrent
72789-565-217278905652121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-21) 2026-08-07NoNoCurrent
72789-565-307278905653030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-30) 2026-04-16NoNoCurrent
72789-565-407278905654040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-40) 2026-09-01NoNoCurrent
72789-565-607278905656060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-60) 2026-04-16NoNoCurrent
72789-565-8272789056582500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-82) 2026-04-16NoNoCurrent
72789-565-8672789056586360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-86) 2026-04-16NoNoCurrent
72789-565-907278905659090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-90) 2026-04-16NoNoCurrent
72789-565-9372789056593180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-93) 2026-04-16NoNoCurrent
72789-565-9472789056594270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-94) 2026-04-16NoNoCurrent