Ibuprofen

Product NDC: 70518-4741
Requested package NDC: 70518-4741-2
11-digit product format: 705184741
Labeler code: 70518
Product ID: 70518-4741_5a6b1d98-dff5-7245-e063-6294a90a6b3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078329
Marketing category: ANDA
Marketing start: 2026-08-31
Substance: IBUPROFEN
Active strength: 600 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
A078329-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05
A078329-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05
A078329-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078329-001	AB
A078329-002	AB
A078329-003	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 · 129 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	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`301d65b070ca…`

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	A078329-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078329-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078329-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078329-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078329-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078329-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078329-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078329-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078329-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078329-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078329-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078329-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078329-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078329-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078329-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078329-001	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	600 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
197806	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
99730c4a-d2ee-46f5-91f4-a15cbaace40d	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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Direct_Rx	40071818-5bf0-095b-e063-6294a90ad58a	2026-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	99730c4a-d2ee-46f5-91f4-a15cbaace40d	2026-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329 ndc (package): 70518-4741-2 ndc (product): 70518-4741 ndc11 (package): 70518474102
Ibuprofen	IBUPROFEN	St. Mary's Medical Park Pharmacy	88dd304f-1c64-08e3-e053-2a95a90a596f	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	ST. MARY'S MEDICAL PARK PHARMACY	88dda062-2b9c-3632-e053-2a95a90a1431	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	60c731c6-4dc4-490a-8469-0b7e58e563a1	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	1ebf94fb-76b6-4c01-be1b-575062827545	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	0550fa2f-f25e-4abb-b10e-a3d05bdb3217	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	c38a03fa-6b9a-4737-a848-063ca5c580b9	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Strides Pharma Science Limited	a266a3c6-932f-476f-ae93-48a785c92286	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	06710aef-2631-4925-8e9e-33bae84b5912	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	3b9fdc48-c071-4e2c-e063-6294a90a679f	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Asclemed USA, Inc.	d7ed42c4-371c-4a54-ab15-0630656f0427	2025-08-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	NCS HealthCare of KY, LLC dba Vangard Labs	ab11e142-9e11-4ce4-9671-7e4fe53ffe92	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	NCS HealthCare of KY, LLC dba Vangard Labs	f1842893-7a34-4f77-8231-55fb0c98b22b	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	3732defa-67c2-4b84-8a84-4bbc27b6cb24	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	689dbbe8-4f85-48fe-8efc-fda81b60d37f	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	09621787-9a5c-4abf-9ccd-d6f8d581738f	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	42b92fd7-468c-4fb8-9ff0-31296735df4c	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	7942cc53-1268-4e5f-8db0-f0b3524bb744	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Proficient Rx LP	c5eaa3a9-5aa8-46b0-8cec-639bfb327475	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329

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
70518-4741-2	70518474102	100 POUCH in 1 BOX (70518-4741-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4741-3)	100 pouch	2026-09-01	No	No	Current