Ibuprofen

Product NDC: 52605-123
11-digit product format: 526050123
Labeler code: 52605
Product ID: 52605-123_c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Polygen Pharmaceuticals LLC
Application: ANDA090796
Marketing category: ANDA
Marketing start: 2011-11-28
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 800 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	52605-123		I	Inactivated by FDA	2026-08-17
excluded package	package	52605-123	52605-123-01	I	Inactivated by FDA	2026-08-17
excluded package	package	52605-123	52605-123-05	I	Inactivated by FDA	2026-08-17

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 · 66 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	52605-123-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52605-123-01	`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	52605-123-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52605-123-01	`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	52605-123-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52605-123-01	`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	52605-123-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52605-123-01	`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	52605-123-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52605-123-01	`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	52605-123-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52605-123-01	`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	52605-123-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52605-123-01	`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	52605-123-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52605-123-01	`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	52605-123-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52605-123-01	`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	52605-123-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52605-123-01	`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	52605-123-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52605-123-01	`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	52605-123-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52605-123-01	`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	52605-123-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52605-123-01	`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	52605-123-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52605-123-01	`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	52605-123-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52605-123-01	`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	52605-123-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	52605-123-01	`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	52605-123-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	52605-123-01	`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	52605-123-05	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	52605-123-01	`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	52605-123-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	52605-123-01	`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	52605-123-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52605-123-01	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090796-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21
A090796-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21
A090796-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090796-001	AB
A090796-002	AB
A090796-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090796-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2010-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090796-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2010-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090796-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2010-12-21	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090796-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090796-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090796-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090796-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090796-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090796-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090796-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090796-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090796-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090796-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090796-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090796-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090796-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090796-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090796-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090796-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090796-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090796-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090796-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090796-001	AB	1	`1e350fbaab3a…`

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
52605-123-01	2019-11-13	C162847	48780-1	97449f38-b94b-f6ea-e053-dbdaa90aa703	c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e
52605-123-05	2019-11-13	C162847	48780-1	97449f38-b94b-f6ea-e053-dbdaa90aa703	c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52605-123-01	Ibuprofen	100 in 1 BOTTLE	TABLET, FILM COATED	100		1
52605-123-05	Ibuprofen	500 in 1 BOTTLE	TABLET, FILM COATED	500		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52605-123-05	EA - Each	52605-123	eafd1053-47e7-4f22-a59d-3ab42d38a5d9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52605-123	IBUPROFEN TABLET, FILM COATED [POLYGEN PHARMACEUTICALS LLC]	1	Legacy NDC, 2 package rows	20111128_c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e.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 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	a7756b22-73cf-4262-aa8e-0577ddecd03b	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	St. Mary's Medical Park Pharmacy	950c3ca7-4481-976f-e053-2995a90ad51e	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	St. Mary's Medical Park Pharmacy	95830141-2439-9d45-e053-2995a90ae084	2026-05-01		Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	a348a959-46bc-4ff6-8936-12866fc34a4b	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	c20f1f4d-59b3-6bbe-e053-2a95a90abaf1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	dac07d8f-6b6f-20ab-e053-2a95a90af3ba	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	da6c72ad-009f-3d7f-e053-2995a90a68e9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	QPharma, Inc.	f452d2c3-525f-4933-b146-92351d0ae44f	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	ce5b0429-bbe1-47a4-af5e-0159d3cfd2c3	2025-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	Direct Rx	d88d0544-57a7-4a82-e053-2a95a90a1945	2025-01-21		Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	DIRECT RX	c3f30813-0848-6e8a-e053-2995a90a3dea	2025-01-20		Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	7546e868-d99f-4f8c-b1e9-cc96fd9fa1eb	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	701ee488-c57f-a82c-e053-2991aa0af403	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
IBUPROFEN	IBUPROFEN	NuCare Pharmaceuticals,Inc.	9b02607a-6fab-5205-e053-2a95a90afa26	2025-01-02		Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	b33caad1-8d40-16f2-e053-2a95a90a1b2d	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	Advanced Rx Pharmacy of Tennessee, LLC	bd1ca7af-d640-23fb-e053-2a95a90a8a98	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	Advanced Rx Pharmacy of Tennessee, LLC	f18b6a0a-e42f-083d-e053-2995a90a40e4	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES, INC	ec3e8443-d742-4c25-8516-f0df4ebfccdc	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	e54209c2-f726-440b-ac60-5a72710d2a9b	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	19b06eaf-0d4c-2b4d-e063-6294a90a2eb9	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090796 application number: ANDA090796

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	c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e	1
197806	ibuprofen 600 MG Oral Tablet	PSN	c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e	1
197807	ibuprofen 800 MG Oral Tablet	PSN	c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e	1
197805	ibuprofen 400 MG Oral Tablet	SCD	c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e	1
197806	ibuprofen 600 MG Oral Tablet	SCD	c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e	1
197807	ibuprofen 800 MG Oral Tablet	SCD	c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52605-123-01	52605012301	100 in 1 BOTTLE	Historical
52605-123-05	52605012305	500 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen - Polygen Pharmaceuticals LLC \| Marksans Pharma Limited	Polygen Pharmaceuticals LLC \| Marksans Pharma Limited	2011-11-22	Human Prescription Drug Label	1