ibuprofen

Product NDC: 67046-314
11-digit product format: 670460314
Labeler code: 67046
Product ID: 67046-314_5ad11b1a-77a1-0ad1-e053-2a91aa0a6f2e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA090796
Marketing category: ANDA
Marketing start: 2017-10-05
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 800 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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67046-314		I	Inactivated by FDA	2026-08-17
excluded package	package	67046-314	67046-314-07	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-314	67046-314-14	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-314	67046-314-15	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-314	67046-314-20	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-314	67046-314-21	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-314	67046-314-28	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-314	67046-314-30	I	Inactivated by FDA	2026-08-17
excluded package	package	67046-314	67046-314-60	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 4 · 189 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	67046-314-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-314-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-314-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-314-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-314-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-314-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-314-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67046-314-15	`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	67046-314-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-314-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-314-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-314-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-314-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-314-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-314-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67046-314-15	`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	67046-314-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-314-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-314-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-314-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-314-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-314-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-314-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67046-314-15	`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	67046-314-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-314-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-314-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-314-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-314-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-314-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-314-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67046-314-15	`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	67046-314-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-314-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-314-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-314-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-314-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-314-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-314-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67046-314-15	`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	67046-314-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-314-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-314-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-314-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-314-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-314-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-314-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67046-314-15	`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	67046-314-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-314-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-314-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-314-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67046-314-30	`302b2466d912…`	`e7b80fea0513…`

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, Related label table
NDC	Related label
67046-314-07	314 Ibuprofen 800 mg
67046-314-14	314 Ibuprofen 800 mg
67046-314-15	314 Ibuprofen 800 mg
67046-314-20	314 Ibuprofen 800 mg
67046-314-21	314 Ibuprofen 800 mg
67046-314-28	314 Ibuprofen 800 mg
67046-314-30	314 Ibuprofen 800 mg
67046-314-60	314 Ibuprofen 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67046-314-07	ibuprofen	7 in 1 BLISTER PACK	TABLET	7	1
67046-314-14	ibuprofen	14 in 1 BLISTER PACK	TABLET	14	1
67046-314-15	ibuprofen	15 in 1 BLISTER PACK	TABLET	15	1
67046-314-20	ibuprofen	20 in 1 BLISTER PACK	TABLET	20	1
67046-314-21	ibuprofen	21 in 1 BLISTER PACK	TABLET	21	1
67046-314-28	ibuprofen	28 in 1 BLISTER PACK	TABLET	28	1
67046-314-30	ibuprofen	30 in 1 BLISTER PACK	TABLET	30	1
67046-314-60	ibuprofen	60 in 1 BLISTER PACK	TABLET	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-314	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1	Legacy NDC, 8 package rows	20171005_5ad11b1a-77a0-0ad1-e053-2a91aa0a6f2e.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
197807	ibuprofen 800 MG Oral Tablet	PSN	5ad11b1a-77a0-0ad1-e053-2a91aa0a6f2e	1
197807	ibuprofen 800 MG Oral Tablet	SCD	5ad11b1a-77a0-0ad1-e053-2a91aa0a6f2e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67046-314-07	67046031407	7 in 1 BLISTER PACK	Historical
67046-314-14	67046031414	14 in 1 BLISTER PACK	Historical
67046-314-15	67046031415	15 in 1 BLISTER PACK	Historical
67046-314-20	67046031420	20 in 1 BLISTER PACK	Historical
67046-314-21	67046031421	21 in 1 BLISTER PACK	Historical
67046-314-28	67046031428	28 in 1 BLISTER PACK	Historical
67046-314-30	67046031430	30 in 1 BLISTER PACK	Historical
67046-314-60	67046031460	60 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
314 Ibuprofen 800 mg	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2017-10-05	HUMAN PRESCRIPTION DRUG LABEL	1