Ibuprofen

Product NDC: 85509-1466
11-digit product format: 855091466
Labeler code: 85509
Product ID: 85509-1466_40202c76-4276-88fd-e063-6394a90a07b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: PHOENIX RX LLC
Application: ANDA078558
Marketing category: ANDA
Marketing start: 2009-11-23
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078558-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18
A078558-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18
A078558-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078558-001	AB
A078558-002	AB
A078558-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078558-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078558-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078558-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078558-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Listing expiration: 2026-12-31

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
40202c76-4275-88fd-e063-6394a90a07b2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
85509-1466-3	Ibuprofen	30 in 1 BOTTLE	TABLET	30	1
85509-1466-6	Ibuprofen	60 in 1 BOTTLE	TABLET	60	1
85509-1466-9	Ibuprofen	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85509-1466-3	EA - Each	85509-1466	dbf69f08-7cbd-4190-b0ec-8fc01cebc9de	1	2025-11-13
85509-1466-6	EA - Each	85509-1466	63545523-0e4e-4ac8-aecb-36fb2df50e1b	1	2025-11-13
85509-1466-9	EA - Each	85509-1466	ac46d50e-6d7c-4fbd-b857-645688791382	1	2025-11-13

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 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals LLC	17577b3b-e755-45d1-8b53-775d058578b2	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	0387bfaa-daca-48ec-b718-0216a848c16a	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	PHOENIX RX LLC	40202c76-4275-88fd-e063-6394a90a07b2	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558 ndc (product): 85509-1466
Ibuprofen	IBUPROFEN	American Health Packaging	e080f7da-a506-4c04-a227-c1be77234f01	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	334e40f3-6da4-ecbe-e063-6294a90a35bf	2025-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fc871659-ce41-1be6-e053-6294a90aa5e4	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	af9af7f4-6314-6217-e053-2995a90a5a0f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	faebc392-0fd9-4c71-8471-beba10dda022	2024-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1a02fa34-b5ae-7183-e063-6294a90a3ae4	2024-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	e90c573d-eb0f-45a5-94d1-efdd3d2b7a11	2024-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	A-S Medication Solutions	fa99f5ec-0306-473b-827f-86cd0a7978ec	2023-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Proficient Rx LP	e4bb22bb-6df6-4016-a023-0b454df9fb0b	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Proficient Rx LP	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197807	ibuprofen 800 MG Oral Tablet	PSN	40202c76-4275-88fd-e063-6394a90a07b2	1
197807	ibuprofen 800 MG Oral Tablet	SCD	40202c76-4275-88fd-e063-6394a90a07b2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85509-1466-3	85509146603	30 TABLET in 1 BOTTLE (85509-1466-3)	30 tablet	2025-10-01	No	No	Current
85509-1466-6	85509146606	60 TABLET in 1 BOTTLE (85509-1466-6)	60 tablet	2025-10-01	No	No	Current
85509-1466-9	85509146609	90 TABLET in 1 BOTTLE (85509-1466-9)	90 tablet	2025-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, USP (400 mg , 600 mg and 800 mg) Rx only	PHOENIX RX LLC	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	1