Ibuprofen

Product NDC: 69367-396
11-digit product format: 693670396
Labeler code: 69367
Product ID: 69367-396_786c8d96-734d-4905-ae64-490c41bfbf40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Westminster Pharmaceuticals, LLC
Application: ANDA202413
Marketing category: ANDA
Marketing start: 2024-05-23
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 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: 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 · 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
eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	Strength	SPL version
69367-396-01	Ibuprofen	100 in 1 BOTTLE	TABLET, FILM COATED	100		2
69367-396-05	Ibuprofen	500 in 1 BOTTLE	TABLET, FILM COATED	500		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69367-396-01	EA - Each	69367-396	742aeea4-b471-4621-a8d0-4adec4162baf	1	2024-07-12
69367-396-05	EA - Each	69367-396	53061d4d-c338-4b08-951d-2df2f3054183	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69367-396	IBUPROFEN TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC]	2	Current NDC, 2 package rows	20241030_eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d.zip

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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Redpharm Drug	44f609dd-c868-493f-e063-6294a90a7138	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	A-S Medication Solutions	71b5b2a2-397e-4dcb-b0c7-ef08df4337e0	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	A-S Medication Solutions	47711610-6577-4805-a2ce-cf9b7cbfa812	2025-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	41351cc0-5ec6-2f4d-e063-6294a90a733a	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Coupler LLC	410f7320-4caa-8f88-e063-6394a90acf93	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	a85080d7-50b4-461b-9d77-d6fbab971c03	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	PHOENIX RX LLC	3b17587e-b609-42a9-e063-6294a90ab1f8	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	SOLA Pharmaceuticals, LLC	44fb0842-c34e-477e-96df-350cd5d6800e	2025-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	388e68dc-1822-f375-e063-6294a90a3d41	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	2c3f8149-9b77-54cd-e063-6394a90a847e	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	3520deb7-5e45-3d0f-e063-6394a90ab44b	2025-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	34673d3b-41cd-f4c9-e063-6394a90a8510	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	3467b45b-c432-2923-e063-6394a90a1044	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Brisk Pharmaceuticals	2dcbe4bb-fb24-e827-e063-6394a90acf9f	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	A-S Medication Solutions	2d0c2d35-c212-4daa-b2c4-b407ca0b16ad	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	A-S Medication Solutions	2b470e48-c23c-4f5c-916a-d38d8518896b	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	A-S Medication Solutions	df0e55d0-617c-4084-984f-ece2f640e715	2024-10-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	A-S Medication Solutions	b0917020-f0ec-4d07-8fbf-c1eb909f466b	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	A-S Medication Solutions	b365be3a-91ad-46bf-a949-103c81f2359a	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Westminster Pharmaceuticals, LLC	eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413 ndc (product): 69367-396

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	ab2f1a30-611b-41b6-9baf-6a82305da845	6
197807	ibuprofen 800 MG Oral Tablet	SCD	ab2f1a30-611b-41b6-9baf-6a82305da845	6
197807	ibuprofen 800 MG Oral Tablet	PSN	2e0f74a5-b8f3-fc81-e063-6394a90a647a	5
197807	ibuprofen 800 MG Oral Tablet	SCD	2e0f74a5-b8f3-fc81-e063-6394a90a647a	5
197807	ibuprofen 800 MG Oral Tablet	PSN	404df13d-4ada-4324-9eed-e21f5d5043a4	4
197807	ibuprofen 800 MG Oral Tablet	SCD	404df13d-4ada-4324-9eed-e21f5d5043a4	4
197807	ibuprofen 800 MG Oral Tablet	PSN	0170876a-d8cd-4a2d-8397-db2acdf72ffb	3
197807	ibuprofen 800 MG Oral Tablet	PSN	2d0c2d35-c212-4daa-b2c4-b407ca0b16ad	3
197807	ibuprofen 800 MG Oral Tablet	SCD	2d0c2d35-c212-4daa-b2c4-b407ca0b16ad	3
197807	ibuprofen 800 MG Oral Tablet	SCD	0170876a-d8cd-4a2d-8397-db2acdf72ffb	3
197805	ibuprofen 400 MG Oral Tablet	PSN	eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d	2
197806	ibuprofen 600 MG Oral Tablet	PSN	eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d	2
197807	ibuprofen 800 MG Oral Tablet	PSN	4e67aef4-c3ac-232a-e063-6394a90a3a85	2
197807	ibuprofen 800 MG Oral Tablet	PSN	eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d	2
197807	ibuprofen 800 MG Oral Tablet	PSN	b84ea215-e61d-4c00-8a34-d47c4080779b	2
197807	ibuprofen 800 MG Oral Tablet	PSN	44f278ac-6bf9-6aef-e063-6394a90a0bb6	2
197807	ibuprofen 800 MG Oral Tablet	PSN	3b17587e-b609-42a9-e063-6294a90ab1f8	2
197805	ibuprofen 400 MG Oral Tablet	SCD	eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d	2
197806	ibuprofen 600 MG Oral Tablet	SCD	eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d	2
197807	ibuprofen 800 MG Oral Tablet	SCD	3b17587e-b609-42a9-e063-6294a90ab1f8	2
197807	ibuprofen 800 MG Oral Tablet	SCD	44f278ac-6bf9-6aef-e063-6394a90a0bb6	2
197807	ibuprofen 800 MG Oral Tablet	SCD	4e67aef4-c3ac-232a-e063-6394a90a3a85	2
197807	ibuprofen 800 MG Oral Tablet	SCD	eeb8312f-7fd9-4c4f-8264-a7e63ff1aa9d	2
197807	ibuprofen 800 MG Oral Tablet	SCD	b84ea215-e61d-4c00-8a34-d47c4080779b	2
197805	ibuprofen 400 MG Oral Tablet	PSN	ca81671d-1ea8-4c67-802f-adb3a2f087cc	1
197806	ibuprofen 600 MG Oral Tablet	PSN	ca81671d-1ea8-4c67-802f-adb3a2f087cc	1
197807	ibuprofen 800 MG Oral Tablet	PSN	2dcbe4bb-fb24-e827-e063-6394a90acf9f	1
197807	ibuprofen 800 MG Oral Tablet	PSN	0ce79e85-0b8b-436e-b895-ea5c02eaf4ba	1
197807	ibuprofen 800 MG Oral Tablet	PSN	ca81671d-1ea8-4c67-802f-adb3a2f087cc	1
197807	ibuprofen 800 MG Oral Tablet	PSN	410f7320-4caa-8f88-e063-6394a90acf93	1
197807	ibuprofen 800 MG Oral Tablet	PSN	b0917020-f0ec-4d07-8fbf-c1eb909f466b	1
197807	ibuprofen 800 MG Oral Tablet	PSN	34673d3b-41cd-f4c9-e063-6394a90a8510	1
197807	ibuprofen 800 MG Oral Tablet	PSN	8d41cc03-dec6-4949-b7c1-7deb2897e2c4	1
197805	ibuprofen 400 MG Oral Tablet	SCD	ca81671d-1ea8-4c67-802f-adb3a2f087cc	1
197806	ibuprofen 600 MG Oral Tablet	SCD	ca81671d-1ea8-4c67-802f-adb3a2f087cc	1
197807	ibuprofen 800 MG Oral Tablet	SCD	b0917020-f0ec-4d07-8fbf-c1eb909f466b	1
197807	ibuprofen 800 MG Oral Tablet	SCD	ca81671d-1ea8-4c67-802f-adb3a2f087cc	1
197807	ibuprofen 800 MG Oral Tablet	SCD	2dcbe4bb-fb24-e827-e063-6394a90acf9f	1
197807	ibuprofen 800 MG Oral Tablet	SCD	34673d3b-41cd-f4c9-e063-6394a90a8510	1
197807	ibuprofen 800 MG Oral Tablet	SCD	8d41cc03-dec6-4949-b7c1-7deb2897e2c4	1
197807	ibuprofen 800 MG Oral Tablet	SCD	0ce79e85-0b8b-436e-b895-ea5c02eaf4ba	1
197807	ibuprofen 800 MG Oral Tablet	SCD	410f7320-4caa-8f88-e063-6394a90acf93	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69367-396-01	69367039601	100 TABLET, FILM COATED in 1 BOTTLE (69367-396-01)	2024-05-23	No	No	Current
69367-396-05	69367039605	500 TABLET, FILM COATED in 1 BOTTLE (69367-396-05)	2024-05-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg	REMEDYREPACK INC.	2026-09-01	HUMAN PRESCRIPTION DRUG LABEL	5
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg	ST. MARY'S MEDICAL PARK PHARMACY	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg	NuCare Pharmaceuticals, Inc.	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	5
Ibuprofen Tablets, USP 800 mg	Proficient Rx LP	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	6
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg	NuCare Pharmaceuticals, Inc.	2026-02-19	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg	A-S Medication Solutions	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	3
Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mg	Preferred Pharmaceuticals Inc.	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg	Redpharm Drug	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg	Coupler LLC	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP 800 mg	PHOENIX RX LLC	2025-08-01	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg	Aphena Pharma Solutions - Tennessee, LLC	2025-05-05	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP 800 mg	Brisk Pharmaceuticals	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mg	A-S Medication Solutions	2024-10-21	HUMAN PRESCRIPTION DRUG LABEL	3
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg	Westminster Pharmaceuticals, LLC	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mg	A-S Medication Solutions	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mg	A-S Medication Solutions	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mg	A-S Medication Solutions	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mg	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-09-08	HUMAN PRESCRIPTION DRUG LABEL	1