ibuprofen

Product NDC: 67877-295
11-digit product format: 678770295
Labeler code: 67877
Product ID: 67877-295_38dfdb8f-cc61-4b00-af82-c272cbf376e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA090796
Marketing category: ANDA
Marketing start: 2012-02-22
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 600 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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67877-295		I	Inactivated by FDA	2026-08-17
excluded product	product	67877-295		D	Discontinued by firm	2026-08-17
excluded package	package	67877-295	67877-295-07	I	Inactivated by FDA	2026-08-17
excluded package	package	67877-295	67877-295-01	D	Discontinued by firm	2026-08-17
excluded package	package	67877-295	67877-295-05	D	Discontinued by firm	2026-08-17
excluded package	package	67877-295	67877-295-30	D	Discontinued by firm	2026-08-17
excluded package	package	67877-295	67877-295-50	D	Discontinued by firm	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 3 · 154 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-295-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-295-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-295-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-295-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-295-01	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-295-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-295-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-295-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-295-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-295-01	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-295-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-295-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-295-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-295-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-295-01	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-295-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-295-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-295-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-295-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-295-01	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-295-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-295-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-295-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-295-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-295-01	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-295-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-295-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-295-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-295-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-295-01	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-295-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-295-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-295-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-295-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-295-01	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-295-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-295-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-295-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-295-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-295-01	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67877-295-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67877-295-50	`0efc9e666f02…`	`f202fb6c5f17…`

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, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
67877-295-01	9d75b9d0-2c8c-f424-e053-dadaa90a57ce	397979cb-f605-4211-b810-0a4572d4b973
67877-295-05	9d75b9d0-2c8c-f424-e053-dadaa90a57ce	397979cb-f605-4211-b810-0a4572d4b973
67877-295-07	9d75b9cf-d157-f424-e053-dadaa90a57ce	Ibuprofen Tablets, USP These highlights do not include all the information needed to use ibuprofen safely and effectively.see full prescribing information for ibuprofen ibuprofen (ibuprofen) TABLET for ORAL use. Initial U.S. Approval:
67877-295-30	9d75b9d0-2c8c-f424-e053-dadaa90a57ce	397979cb-f605-4211-b810-0a4572d4b973
67877-295-50	9d75b9d0-2c8c-f424-e053-dadaa90a57ce	397979cb-f605-4211-b810-0a4572d4b973

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67877-295-01	ibuprofen	100 in 1 BOTTLE	TABLET	100	3
67877-295-05	ibuprofen	500 in 1 BOTTLE	TABLET	500	3
67877-295-30	ibuprofen	30 in 1 BOTTLE	TABLET	30	3
67877-295-50	ibuprofen	50 in 1 BOTTLE	TABLET	50	3
67877-295-07	ibuprofen	7 in 1 BOTTLE	TABLET	7	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-295-01	EA - Each	67877-295	bf95c5d2-0ace-4167-aea9-9e13f62c31e5	1	2013-02-13
67877-295-05	EA - Each	67877-295	610b711c-bfbb-4fb5-9900-d30c91ac771c	1	2013-02-13
67877-295-30	EA - Each	67877-295	6f2a863d-1105-44a3-9884-12f6af785cda	1	2013-12-02
67877-295-50	EA - Each	67877-295	89899d74-2832-4ce3-8b32-181fadd2acc2	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3
ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [NORTHWIND PHARMACEUTICALS, LLC]	2
ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [RXCHANGE CO.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [NORTHWIND PHARMACEUTICALS, LLC]	2
ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [RXCHANGE CO.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [RXCHANGE CO.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [RXCHANGE CO.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [RXCHANGE CO.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [RXCHANGE CO.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [RXCHANGE CO.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [RXCHANGE CO.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [RXCHANGE CO.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [RXCHANGE CO.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [RXCHANGE CO.]	2
ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [PROFICIENT RX LP]	1
ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	1
ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [PROFICIENT RX LP]	1
ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [PROFICIENT RX LP]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-295	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	3	Legacy NDC, 4 package rows	20150115_397979cb-f605-4211-b810-0a4572d4b973.zip
67877-295	IBUPROFEN TABLET [ASCEND LABORATORIES, LLC]	2	Legacy NDC, 1 package rows	20160105_ed1dc2d6-d0eb-4731-a0cd-31a64fe1ebd2.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	397979cb-f605-4211-b810-0a4572d4b973	3
197806	ibuprofen 600 MG Oral Tablet	PSN	924d2dd0-3b7d-42ec-b617-86729dba2b95	3
197806	ibuprofen 600 MG Oral Tablet	PSN	397979cb-f605-4211-b810-0a4572d4b973	3
197807	ibuprofen 800 MG Oral Tablet	PSN	397979cb-f605-4211-b810-0a4572d4b973	3
197805	ibuprofen 400 MG Oral Tablet	SCD	397979cb-f605-4211-b810-0a4572d4b973	3
197806	ibuprofen 600 MG Oral Tablet	SCD	924d2dd0-3b7d-42ec-b617-86729dba2b95	3
197806	ibuprofen 600 MG Oral Tablet	SCD	397979cb-f605-4211-b810-0a4572d4b973	3
197807	ibuprofen 800 MG Oral Tablet	SCD	397979cb-f605-4211-b810-0a4572d4b973	3
197806	ibuprofen 600 MG Oral Tablet	PSN	373aad4c-45a6-4e69-8791-d4f93c2f645c	2
197806	ibuprofen 600 MG Oral Tablet	PSN	ed1dc2d6-d0eb-4731-a0cd-31a64fe1ebd2	2
197806	ibuprofen 600 MG Oral Tablet	SCD	373aad4c-45a6-4e69-8791-d4f93c2f645c	2
197806	ibuprofen 600 MG Oral Tablet	SCD	ed1dc2d6-d0eb-4731-a0cd-31a64fe1ebd2	2
197805	ibuprofen 400 MG Oral Tablet	PSN	37a7a356-bd9e-4dd8-98cc-bd3650a09105	1
197806	ibuprofen 600 MG Oral Tablet	PSN	37a7a356-bd9e-4dd8-98cc-bd3650a09105	1
197807	ibuprofen 800 MG Oral Tablet	PSN	37a7a356-bd9e-4dd8-98cc-bd3650a09105	1
197805	ibuprofen 400 MG Oral Tablet	SCD	37a7a356-bd9e-4dd8-98cc-bd3650a09105	1
197806	ibuprofen 600 MG Oral Tablet	SCD	37a7a356-bd9e-4dd8-98cc-bd3650a09105	1
197807	ibuprofen 800 MG Oral Tablet	SCD	37a7a356-bd9e-4dd8-98cc-bd3650a09105	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67877-295-01	67877029501	100 in 1 BOTTLE	Historical
67877-295-05	67877029505	500 in 1 BOTTLE	Historical
67877-295-07	67877029507	7 in 1 BOTTLE	Historical
67877-295-30	67877029530	30 in 1 BOTTLE	Historical
67877-295-50	67877029550	50 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ibuprofen - Proficient Rx LP	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
ibuprofen	Ascend Laboratories, LLC \| MARKSANS PHARMA LIMITED \| EPM Packaging, Inc.	2015-11-16	HUMAN PRESCRIPTION DRUG LABEL	2
ibuprofen - Blenheim Pharmacal, Inc.	Blenheim Pharmacal, Inc.	2015-03-05	HUMAN PRESCRIPTION DRUG LABEL	1
ibuprofen - Ascend Laboratories, LLC \| MARKSANS PHARMA LIMITED	Ascend Laboratories, LLC \| MARKSANS PHARMA LIMITED	2015-01-15	HUMAN PRESCRIPTION DRUG LABEL	3
ibuprofen - RxChange Co.	RxChange Co.	2014-11-14	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen 600 MG	Northwind Pharmaceuticals, LLC \| Northwind Pharmaceuticals,LLC	2014-09-30	HUMAN PRESCRIPTION DRUG LABEL	2