Ibuprofen

Product NDC: 85534-0013
11-digit product format: 855340013
Labeler code: 85534
Product ID: 85534-0013_55221d60-54df-9469-e063-6294a90a2f91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: HAWAII REPACK, INC.
Application: ANDA213794
Marketing category: ANDA
Marketing start: 2020-05-08
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213794-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08
A213794-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08
A213794-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213794-001	AB
A213794-002	AB
A213794-003	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 3 · 117 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	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 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	A213794-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213794-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213794-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213794-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213794-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213794-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213794-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213794-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213794-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-001	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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197805	Internal RxNorm lookup
197806	Internal RxNorm lookup
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
6239818c-747d-4cbb-9b41-27ca8bbce41b	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 2 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	A-S Medication Solutions	4b75bd6f-5455-4237-991c-eacc0fdcf709	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Direct_rx	1be33b4f-4987-580f-e063-6294a90a3103	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	7acdd557-0b6c-48f5-9437-7bc567af1f85	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	86fc38bc-7f54-4aab-9c4d-d0898a4381f9	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	d50f829d-071f-4299-9b74-0f28caac7118	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31f61d5c-a3a3-3d47-e063-6394a90afb62	2025-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Aurobindo Pharma Limited	00872852-680a-41b3-901b-b991b12a176d	2025-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fae53f7b-3948-2566-e053-6394a90aae36	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	0bee69ff-cf76-175e-e063-6294a90a42f6	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fe939219-d752-63a0-e053-6394a90a0ab2	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Quality Care Products, LLC	246b120e-3458-4721-bf95-82537feaa131	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Quality Care Products, LLC	56f1d6a9-6804-4235-a600-f7c8e458f693	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	1ef5693b-d00a-28fb-e063-6294a90a7ede	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	23fb1113-9f1c-88e0-e063-6394a90a4450	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	f1f1e0ac-6944-4123-9e08-1df91582d457	2023-12-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Asclemed USA, Inc.	793e4b36-8208-4fa3-9f4f-9e9e72648280	2023-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	408c977c-2cf7-4175-877d-d221ed49248a	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	1991c503-ef6e-42dc-ada4-f909962dd789	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794

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	Units	Marketing start	Sample	Exclude flag	Status
85534-0013-0	85534001300	30 TABLET in 1 BOTTLE (85534-0013-0)	30 tablet	2026-06-25	No	No	Current
85534-0013-1	85534001301	60 TABLET in 1 BOTTLE (85534-0013-1)	60 tablet	2026-06-25	No	No	Current
85534-0013-2	85534001302	90 TABLET in 1 BOTTLE (85534-0013-2)	90 tablet	2026-06-25	No	No	Current
85534-0013-3	85534001303	120 TABLET in 1 BOTTLE (85534-0013-3)	120 tablet	2026-06-25	No	No	Current