Ibuprofen

Product NDC: 50090-5435
11-digit product format: 500905435
Labeler code: 50090
Product ID: 50090-5435_faf5e083-7764-4a5e-8810-ecfa0ab69017
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA213794
Marketing category: ANDA
Marketing start: 2020-05-08
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: 2026-12-31
Current FDA listing: Yes

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 · 91 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
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5435-5	`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	50090-5435-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5435-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5435-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5435-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5435-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5435-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5435-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-5435-2	`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	50090-5435-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5435-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5435-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5435-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5435-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5435-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5435-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-5435-2	`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	50090-5435-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5435-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5435-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5435-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5435-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5435-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5435-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-5435-2	`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	50090-5435-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5435-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5435-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5435-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5435-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5435-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5435-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-5435-2	`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	50090-5435-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5435-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5435-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5435-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5435-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5435-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5435-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-5435-2	`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	50090-5435-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5435-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5435-7	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5435-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5435-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5435-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5435-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-5435-2	`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	50090-5435-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-5435-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-5435-7	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-5435-5	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A213794-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08
A213794-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08
A213794-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213794-001	AB
A213794-002	AB
A213794-003	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 3 · 120 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
2026-10-15 13:18:30	2026-09	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A213794-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213794-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213794-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213794-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213794-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213794-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213794-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213794-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213794-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213794-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213794-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213794-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-001	AB	1	`79d66fd596c7…`

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	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
4b75bd6f-5455-4237-991c-eacc0fdcf709	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
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	SPL version
50090-5435-0	Ibuprofen	10 in 1 BOTTLE	TABLET	10	13
50090-5435-2	Ibuprofen	16 in 1 BOTTLE	TABLET	16	13
50090-5435-3	Ibuprofen	30 in 1 BOTTLE	TABLET	30	13
50090-5435-4	Ibuprofen	60 in 1 BOTTLE	TABLET	60	13
50090-5435-5	Ibuprofen	100 in 1 BOTTLE	TABLET	100	13
50090-5435-7	Ibuprofen	40 in 1 BOTTLE	TABLET	40	13
50090-5435-8	Ibuprofen	20 in 1 BOTTLE	TABLET	20	13
50090-5435-9	Ibuprofen	24 in 1 BOTTLE	TABLET	24	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5435-0	EA - Each	50090-5435	2bdb24c3-def3-43de-9be3-cb4b6ac82072	1	2025-08-11
50090-5435-2	EA - Each	50090-5435	8c6d16e4-eb10-4e02-af3f-7c79536adea7	1	2025-08-11
50090-5435-3	EA - Each	50090-5435	780746bc-b3d5-49ea-b63f-38be32a23fa5	1	2022-12-07
50090-5435-4	EA - Each	50090-5435	4a49a3e9-d05b-4286-91e8-7b9061c39280	1	2025-08-11
50090-5435-5	EA - Each	50090-5435	c2671294-208d-44de-a335-87582c14306c	1	2025-08-11
50090-5435-7	EA - Each	50090-5435	c1dbf956-9fad-4514-823f-f16371628f32	1	2025-08-11
50090-5435-8	EA - Each	50090-5435	7ec19e68-d66d-4384-9a73-805be1029c8f	1	2025-08-11
50090-5435-9	EA - Each	50090-5435	a461b6b5-a09b-492b-acc9-3c88e5cf0fb3	1	2025-08-11

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	A-S Medication Solutions	4b75bd6f-5455-4237-991c-eacc0fdcf709	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794 ndc (product): 50090-5435
Ibuprofen	IBUPROFEN	Direct_rx	1be33b4f-4987-580f-e063-6294a90a3103	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	7acdd557-0b6c-48f5-9437-7bc567af1f85	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	86fc38bc-7f54-4aab-9c4d-d0898a4381f9	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	d50f829d-071f-4299-9b74-0f28caac7118	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31f61d5c-a3a3-3d47-e063-6394a90afb62	2025-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Aurobindo Pharma Limited	00872852-680a-41b3-901b-b991b12a176d	2025-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fae53f7b-3948-2566-e053-6394a90aae36	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	0bee69ff-cf76-175e-e063-6294a90a42f6	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fe939219-d752-63a0-e053-6394a90a0ab2	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Quality Care Products, LLC	246b120e-3458-4721-bf95-82537feaa131	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Quality Care Products, LLC	56f1d6a9-6804-4235-a600-f7c8e458f693	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	1ef5693b-d00a-28fb-e063-6294a90a7ede	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	23fb1113-9f1c-88e0-e063-6394a90a4450	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	f1f1e0ac-6944-4123-9e08-1df91582d457	2023-12-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Asclemed USA, Inc.	793e4b36-8208-4fa3-9f4f-9e9e72648280	2023-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794

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
197806	ibuprofen 600 MG Oral Tablet	PSN	4b75bd6f-5455-4237-991c-eacc0fdcf709	13
197806	ibuprofen 600 MG Oral Tablet	SCD	4b75bd6f-5455-4237-991c-eacc0fdcf709	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5435-0	50090543500	10 TABLET in 1 BOTTLE (50090-5435-0)	10 tablet	2021-01-18	0000-00-00	No	No	Current
50090-5435-2	50090543502	16 TABLET in 1 BOTTLE (50090-5435-2)	16 tablet	2021-01-18	0000-00-00	No	No	Current
50090-5435-3	50090543503	30 TABLET in 1 BOTTLE (50090-5435-3)	30 tablet	2021-01-18	0000-00-00	No	No	Current
50090-5435-4	50090543504	60 TABLET in 1 BOTTLE (50090-5435-4)	60 tablet	2021-01-18	0000-00-00	No	No	Current
50090-5435-5	50090543505	100 TABLET in 1 BOTTLE (50090-5435-5)	100 tablet	2021-01-18	0000-00-00	No	No	Current
50090-5435-7	50090543507	40 TABLET in 1 BOTTLE (50090-5435-7)	40 tablet	2021-01-18	0000-00-00	No	No	Current
50090-5435-8	50090543508	20 TABLET in 1 BOTTLE (50090-5435-8)	20 tablet	2021-01-18	0000-00-00	No	No	Current
50090-5435-9	50090543509	24 TABLET in 1 BOTTLE (50090-5435-9)	24 tablet	2021-01-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, USP Rx only	A-S Medication Solutions	2025-10-27	Human Prescription Drug Label	13