Ibuprofen

Product NDC: 72789-584
11-digit product format: 727890584
Labeler code: 72789
Product ID: 72789-584_579c4101-4f79-da01-e063-6294a90ab9ce
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202413-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23
A202413-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23
A202413-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23
A202413-004	IBUPROFEN	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202413-001	AB
A202413-002	AB
A202413-003	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202413-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202413-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202413-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202413-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202413-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-001	AB	1	`301d65b070ca…`

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
Ingredient	Strength
IBUPROFEN	800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197807	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
656658cc-8cf0-42b6-af4f-4e3ab7648625	Available on FDA.report

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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	0fa4cd66-66ad-4ec9-b38c-6b5840df39df	2026-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	3a38add6-a114-4e18-836c-3bfc727db231	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	404df13d-4ada-4324-9eed-e21f5d5043a4	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	2572ed69-d5a7-4513-a202-aca3230e7ec5	2026-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	AiPing Pharmaceutical, Inc.	3e131710-2579-446e-8076-f602ecea813f	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	656658cc-8cf0-42b6-af4f-4e3ab7648625	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413 ndc (product): 72789-584
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	c0156053-add5-4bd5-b89f-f90df2e73be4	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Redpharm Drug	5302291e-4816-8495-e063-6394a90a9cc0	2026-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	ST. MARY'S MEDICAL PARK PHARMACY	4e67aef4-c3ac-232a-e063-6394a90a3a85	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	886c974c-0d32-4a1b-8f54-40c2c12efa45	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	2e0f74a5-b8f3-fc81-e063-6394a90a647a	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Proficient Rx LP	ab2f1a30-611b-41b6-9baf-6a82305da845	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	4b34b58b-2cf7-9aa8-e063-6294a90a0658	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	A-S Medication Solutions	0170876a-d8cd-4a2d-8397-db2acdf72ffb	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	70e191ef-8fad-49eb-9850-fceea119e92f	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	b84ea215-e61d-4c00-8a34-d47c4080779b	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Coupler LLC	4831785a-cde2-79a2-e063-6294a90a9a40	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Chartwell RX, LLC	39f2664f-6c0a-4726-85d7-4227530d4a49	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Redpharm Drug	44f278ac-6bf9-6aef-e063-6394a90a0bb6	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Redpharm Drug	44f5743f-8c98-dc4d-e063-6294a90a6dfa	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72789-584-30	72789058430	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-584-30)	2026-07-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, USP 800 mg	PD-Rx Pharmaceuticals, Inc.	2026-07-27	HUMAN PRESCRIPTION DRUG LABEL	2