ibuprofen

Product NDC: 61919-960
11-digit product format: 619190960
Labeler code: 61919
Product ID: 61919-960_f21620df-a19b-7df4-e053-2995a90a00c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA075682
Marketing category: ANDA
Marketing start: 2019-08-20
Marketing end: 0000-00-00
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: 2024-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-960		I	Inactivated by FDA	2026-10-12
excluded product	product	61919-960		I	Inactivated by FDA	2026-10-12
excluded product	product	61919-960		I	Inactivated by FDA	2026-10-12
excluded package	package	61919-960	61919-960-30	I	Inactivated by FDA	2026-10-12
excluded package	package	61919-960	61919-960-90	I	Inactivated by FDA	2026-10-12
excluded package	package	61919-960	61919-960-60	I	Inactivated by FDA	2026-10-12
excluded package	package	61919-960	61919-960-21	I	Inactivated by FDA	2026-10-12
excluded package	package	61919-960	61919-960-72	I	Inactivated by FDA	2026-10-12

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 · 123 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-960-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-960-72	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-960-21	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-960-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-960-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-960-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-960-72	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-960-21	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-960-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-960-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-960-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-960-72	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-960-21	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-960-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-960-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-960-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-960-72	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-960-21	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-960-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-960-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-960-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-960-72	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-960-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-960-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-960-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-960-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-960-72	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-960-21	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-960-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-960-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-960-60	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-960-21	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-960-90	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-960-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-960-72	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-960-60	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075682-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14
A075682-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14
A075682-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075682-001	AB
A075682-002	AB
A075682-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075682-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075682-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075682-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075682-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075682-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075682-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075682-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075682-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075682-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-960-21	2025-01-30	2cef2736-84e9-d83d-e063-dadaa90ab31f	ibuprofen
61919-960-72	2025-01-30	2cef2736-84e9-d83d-e063-dadaa90ab31f	ibuprofen
61919-960-60	2023-01-30	f386c64a-1509-0266-e053-dadaa90a7c1a	ibuprofen
61919-960-30	2020-01-31	9d75b9d1-2a60-f424-e053-dadaa90a57ce	IBUPROFEN
61919-960-90	2020-01-31	9d75b9d1-2a60-f424-e053-dadaa90a57ce	IBUPROFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-960-21	ibuprofen	21 in 1 BOTTLE	TABLET	21	8
61919-960-72	ibuprofen	120 in 1 BOTTLE	TABLET	120	8
61919-960-60	ibuprofen	60 in 1 BOTTLE	TABLET	60	2
61919-960-30	IBUPROFEN	30 in 1 BOTTLE	TABLET	30	1
61919-960-90	IBUPROFEN	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-960-21	EA - Each	61919-960	14854ff4-74e7-495a-a2f0-2d636fbc5c8f	1	2019-11-12
61919-960-60	EA - Each	61919-960	a3e8dcce-f50d-4859-be4f-610e2c9d46e9	1	2019-09-05
61919-960-72	EA - Each	61919-960	c26a3e69-54d3-443d-9f08-d542fa13417e	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [DIRECTRX]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [DIRECTRX]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET [DIRECTRX]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [DIRECTRX]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [DIRECTRX]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET [DIRECTRX]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [DIRECTRX]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN TABLET [DIRECTRX]	1
Polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [DIRECTRX]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN TABLET [DIRECTRX]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [DIRECTRX]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-960	IBUPROFEN TABLET IBUPROFEN TABLET, FILM COATED [DIRECT_RX]	8	Legacy NDC, 2 package rows	20230113_908e725f-bd99-6d0b-e053-2995a90aefb2.zip
61919-960	IBUPROFEN TABLET [DIRECT_RX]	2	Legacy NDC, 1 package rows	20210113_908e725f-bd90-6d0b-e053-2995a90aefb2.zip
61919-960	IBUPROFEN TABLET [DIRECTRX]	1	Legacy NDC, 2 package rows	20151022_82a4f9da-6f37-4686-aff2-c453bcf1dfd5.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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	ffec2f44-1144-4729-b43a-1db40ea6a8d3	2019-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682

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	908e725f-bd99-6d0b-e053-2995a90aefb2	8
197806	ibuprofen 600 MG Oral Tablet	PSN	908e725f-bd99-6d0b-e053-2995a90aefb2	8
197805	ibuprofen 400 MG Oral Tablet	SCD	908e725f-bd99-6d0b-e053-2995a90aefb2	8
197806	ibuprofen 600 MG Oral Tablet	SCD	908e725f-bd99-6d0b-e053-2995a90aefb2	8
197806	ibuprofen 600 MG Oral Tablet	PSN	908e725f-bd90-6d0b-e053-2995a90aefb2	2
197806	ibuprofen 600 MG Oral Tablet	SCD	908e725f-bd90-6d0b-e053-2995a90aefb2	2
197806	ibuprofen 600 MG Oral Tablet	PSN	82a4f9da-6f37-4686-aff2-c453bcf1dfd5	1
197806	ibuprofen 600 MG Oral Tablet	SCD	82a4f9da-6f37-4686-aff2-c453bcf1dfd5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-960-21	61919096021	21 TABLET in 1 BOTTLE (61919-960-21)	21 tablet	2019-08-20	0000-00-00	No	No	Current
61919-960-30	61919096030	30 in 1 BOTTLE						Historical
61919-960-60	61919096060	60 TABLET in 1 BOTTLE (61919-960-60)	60 tablet	2019-08-20	0000-00-00	No	No	Current
61919-960-72	61919096072	120 TABLET in 1 BOTTLE (61919-960-72)	120 tablet	2019-08-20	0000-00-00	No	No	Current
61919-960-90	61919096090	90 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ibuprofen	Direct_Rx	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	8
ibuprofen	Direct_Rx	2021-01-12	HUMAN PRESCRIPTION DRUG LABEL	2
IBUPROFEN	DirectRX	2015-10-21	HUMAN PRESCRIPTION DRUG LABEL	1