Ibuprofen

Product NDC: 69150-400
11-digit product format: 691500400
Labeler code: 69150
Product ID: 69150-400_bf68e5f3-a07d-4674-bc03-d4ba7bf42df4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IBUPROFEN
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Biomes Pharmaceuticals LLC
Application: ANDA078329
Marketing category: ANDA
Marketing start: 2009-05-02
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 400 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69150-400		I	Inactivated by FDA	2026-10-05
excluded package	package	69150-400	69150-400-10	I	Inactivated by FDA	2026-10-05
excluded package	package	69150-400	69150-400-50	I	Inactivated by FDA	2026-10-05

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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69150-400-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69150-400-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69150-400-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69150-400-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69150-400-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69150-400-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69150-400-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69150-400-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69150-400-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69150-400-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69150-400-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69150-400-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69150-400-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69150-400-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69150-400-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69150-400-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69150-400-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69150-400-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69150-400-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69150-400-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69150-400-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69150-400-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69150-400-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69150-400-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69150-400-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69150-400-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69150-400-50	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69150-400-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69150-400-50	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69150-400-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69150-400-50	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69150-400-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69150-400-50	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69150-400-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69150-400-50	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69150-400-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69150-400-50	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69150-400-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69150-400-50	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69150-400-10	`e2bbac7714bc…`	`27bdfed8d636…`

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.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69150-400-10	2020-01-31	C162847	48780-1	9d75b9d0-bea5-f424-e053-dadaa90a57ce	a206793a-b8a1-4e47-99a4-7a76c7e2e43d
69150-400-50	2020-01-31	C162847	48780-1	9d75b9d0-bea5-f424-e053-dadaa90a57ce	a206793a-b8a1-4e47-99a4-7a76c7e2e43d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69150-400-10	Ibuprofen	100 in 1 BOTTLE	TABLET, COATED	100		1
69150-400-50	Ibuprofen	500 in 1 BOTTLE	TABLET, COATED	500		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69150-400	IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC]	1	Legacy NDC, 2 package rows	20141114_a206793a-b8a1-4e47-99a4-7a76c7e2e43d.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 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197805	ibuprofen 400 MG Oral Tablet	PSN	a206793a-b8a1-4e47-99a4-7a76c7e2e43d	1
197805	ibuprofen 400 MG Oral Tablet	SCD	a206793a-b8a1-4e47-99a4-7a76c7e2e43d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69150-400-10	69150040010	100 in 1 BOTTLE	Historical
69150-400-50	69150040050	500 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen - Biomes Pharmaceuticals LLC	Biomes Pharmaceuticals LLC	2014-11-01	HUMAN PRESCRIPTION DRUG LABEL	1