Ibuprofen

Product NDC: 68788-8201
Requested package NDC: 68788-8201-1
11-digit product format: 687888201
Labeler code: 68788
Product ID: 68788-8201_44842e31-504a-4ab8-9f62-f188f89b9061
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA071268
Marketing category: ANDA
Marketing start: 2022-05-23
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 400 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-8201	68788-8201-1	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-8201	68788-8201-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-8201	68788-8201-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A071268-001	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15
A071268-002	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15
A071268-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071268-001	AB
A071268-002	AB
A071268-003	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	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-002	IBUPROFEN	400MG	TABLET / ORAL	AB	1986-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-003	IBUPROFEN	800MG	TABLET / ORAL	AB	1988-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071268-001	IBUPROFEN	600MG	TABLET / ORAL	AB	1986-10-15	`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	A071268-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071268-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071268-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071268-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071268-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071268-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071268-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071268-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071268-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071268-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071268-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071268-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071268-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071268-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071268-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071268-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071268-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071268-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071268-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071268-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8201-1	EA - Each	68788-8201	3336060a-8bb0-4a98-b863-499dcffed6fd	1	2022-07-06
68788-8201-2	EA - Each	68788-8201	c8b0d193-5729-4b89-8501-a35f50dc43ea	1	2022-07-06
68788-8201-3	EA - Each	68788-8201	f3ccfe7f-a5a7-47d3-9641-907766b85ead	1	2022-07-06
68788-8201-5	EA - Each	68788-8201	d677e92a-4bcc-4735-8563-38248a7e456d	1	2022-07-06
68788-8201-6	EA - Each	68788-8201	6d725303-ba96-4adc-af31-18204aa48062	1	2022-07-06
68788-8201-8	EA - Each	68788-8201	77576c7d-1635-41f1-8683-ceb991c83977	1	2022-08-04
68788-8201-9	EA - Each	68788-8201	11d52240-0929-413e-844f-936fde1f137a	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8201	IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	3	Legacy NDC	20240526_44842e31-504a-4ab8-9f62-f188f89b9061.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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	42b6faf5-ef47-6a7a-e063-6394a90ac409	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071268 application number: ANDA071268
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	f4d6372a-d560-0e14-e053-2a95a90a435a	2024-12-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071268 application number: ANDA071268
Ibuprofen	IBUPROFEN	Florida Pharmaceutical Products, LLC	c1733fdb-5eed-2094-e053-2995a90a6c8e	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071268 application number: ANDA071268

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	Marketing end	Sample	Exclude flag	Status
68788-8201-1	68788820101	100 TABLET, FILM COATED in 1 BOTTLE (68788-8201-1)	2022-05-23	0000-00-00	No	No	Current