Ibuprofen

Product NDC: 68071-2903
11-digit product format: 680712903
Labeler code: 68071
Product ID: 68071-2903_efbb5e80-b38f-7fed-e053-2995a90a5a90
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA213794
Marketing category: ANDA
Marketing start: 2020-05-08
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 800 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: 2023-12-31
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	68071-2903		I	Inactivated by FDA	2026-08-07
excluded package	package	68071-2903	68071-2903-1	I	Inactivated by FDA	2026-08-07
excluded package	package	68071-2903	68071-2903-4	I	Inactivated by FDA	2026-08-07
excluded package	package	68071-2903	68071-2903-5	I	Inactivated by FDA	2026-08-07
excluded package	package	68071-2903	68071-2903-6	I	Inactivated by FDA	2026-08-07
excluded package	package	68071-2903	68071-2903-7	I	Inactivated by FDA	2026-08-07
excluded package	package	68071-2903	68071-2903-9	I	Inactivated by FDA	2026-08-07

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 · 63 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 package	package	68071-2903-7	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2903-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2903-5	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2903-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2903-9	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2903-1	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 package	package	68071-2903-7	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2903-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2903-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2903-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2903-9	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2903-1	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 package	package	68071-2903-7	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2903-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2903-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2903-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2903-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2903-1	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 package	package	68071-2903-7	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2903-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2903-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2903-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2903-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2903-1	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 package	package	68071-2903-7	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2903-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2903-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2903-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2903-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2903-1	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 package	package	68071-2903-7	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2903-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2903-5	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2903-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2903-9	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2903-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
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 package	package	68071-2903-9	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2903-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2903-4	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2903-5	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2903-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2903-7	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
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 package	package	68071-2903-9	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2903-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2903-4	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2903-5	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2903-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2903-7	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2903-9	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2903-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2903-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 111 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
2026-02-19 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213794-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68071-2903-1	Ibuprofen Tablets, USP Rx only
68071-2903-4	Ibuprofen Tablets, USP Rx only
68071-2903-5	Ibuprofen Tablets, USP Rx only
68071-2903-6	Ibuprofen Tablets, USP Rx only
68071-2903-7	Ibuprofen Tablets, USP Rx only
68071-2903-9	Ibuprofen Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-2903-1	Ibuprofen	21 in 1 BOTTLE	TABLET	21	7
68071-2903-4	Ibuprofen	40 in 1 BOTTLE	TABLET	40	7
68071-2903-5	Ibuprofen	15 in 1 BOTTLE	TABLET	15	7
68071-2903-6	Ibuprofen	60 in 1 BOTTLE	TABLET	60	7
68071-2903-7	Ibuprofen	12 in 1 BOTTLE	TABLET	12	7
68071-2903-9	Ibuprofen	90 in 1 BOTTLE	TABLET	90	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2903	IBUPROFEN TABLET [NUCARE PHARMACEUTICALS,INC.]	7	Legacy NDC, 6 package rows	20230613_efbb5bca-1796-76d1-e053-2995a90a0bc8.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 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	St. Mary's Medical Park Pharmacy	0a98cce4-f5c0-12a8-e063-6294a90a4e7e	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Proficient Rx LP	34a9b94f-93ba-4a7c-92eb-d0b4b530d887	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	HAWAII REPACK, INC.	6239818c-747d-4cbb-9b41-27ca8bbce41b	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Sportpharm LLC	cef04ae4-e78a-454d-bb66-84b1d348c106	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Unit Dose Solutions, Inc.	5515e80f-7513-b425-e063-6294a90aa542	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	2fa4bfc8-386c-433b-bc46-24fc8ec1bca1	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	ec6b2df4-2f4f-4601-8b53-0542664e0bd9	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	bdc3f482-6fba-4420-9118-0f5cb7744e97	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	13fd4401-1821-4f2b-a44e-96aa2fa75b5c	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	25d9f5fc-4d95-4018-add8-ba696b6079b2	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	05ce8e8e-0b25-061e-e063-6394a90a2e92	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Coupler LLC	50766a3d-1a22-be14-e063-6294a90a0ed2	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NorthStar Rx LLC	aeee629b-255c-40d8-8e95-779aec00f723	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Direct_Rx	1aa11b52-1aca-9219-e063-6294a90a470f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	f24582be-8d70-4848-bd54-e55fa28f394f	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	e5db46f3-043b-40ac-a89b-c90bd562e7b4	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	3db0c659-cc43-45dc-8442-bc89093d94d7	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	f60445d3-807e-0bbf-e053-2995a90a1299	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	8d5f7d2a-af48-4d47-8bf5-48f01c092d24	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
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

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	efbb5bca-1796-76d1-e053-2995a90a0bc8	7
197807	ibuprofen 800 MG Oral Tablet	SCD	efbb5bca-1796-76d1-e053-2995a90a0bc8	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2903-1	68071290301	21 in 1 BOTTLE						Historical
68071-2903-4	68071290304	40 in 1 BOTTLE						Historical
68071-2903-5	68071290305	15 TABLET in 1 BOTTLE (68071-2903-5)	15 tablet	2022-12-13	0000-00-00	No	No	Current
68071-2903-6	68071290306	60 in 1 BOTTLE						Historical
68071-2903-7	68071290307	12 in 1 BOTTLE						Historical
68071-2903-9	68071290309	90 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mpm Pak	NuCare Pharmaceuticals,Inc.	2023-08-07	HUMAN PRESCRIPTION DRUG LABEL	2
Mpm Pak	NuCare Pharmaceuticals,Inc.	2023-06-14	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP Rx only	NuCare Pharmaceuticals,Inc. \| NuCare Pharamaceuticals,Inc.	2023-06-12	HUMAN PRESCRIPTION DRUG LABEL	7
Mpm Pak	NuCare Pharmaceuticals,Inc.	2023-02-24	HUMAN PRESCRIPTION DRUG LABEL	1