Ibuprofen

Product NDC: 60760-597
11-digit product format: 607600597
Labeler code: 60760
Product ID: 60760-597_51cca64c-9a12-9785-e063-6394a90af9be
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ST. MARY'S MEDICAL PARK PHARMACY
Application: ANDA078329
Marketing category: ANDA
Marketing start: 2019-05-02
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: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	60760-597-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60760-597-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	60760-597-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	60760-597-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60760-597-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	60760-597-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	60760-597-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60760-597-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	60760-597-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	60760-597-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60760-597-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	60760-597-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	60760-597-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60760-597-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60760-597-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	60760-597-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60760-597-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60760-597-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	60760-597-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	60760-597-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	60760-597-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	60760-597-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	60760-597-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	60760-597-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	60760-597-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	60760-597-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	60760-597-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078329-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05
A078329-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05
A078329-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078329-001	AB
A078329-002	AB
A078329-003	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 · 123 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	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A078329-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078329-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078329-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078329-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078329-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078329-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078329-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078329-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078329-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078329-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078329-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078329-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078329-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078329-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078329-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078329-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078329-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078329-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078329-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078329-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078329-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078329-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078329-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078329-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197806	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88dda062-2b9c-3632-e053-2a95a90a1431	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60760-597-20	Ibuprofen	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	11
60760-597-28	Ibuprofen	28 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	28	11
60760-597-30	Ibuprofen	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	11
60760-597-40	Ibuprofen	40 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	40	11
60760-597-60	Ibuprofen	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	11
60760-597-90	Ibuprofen	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-597-20	EA - Each	60760-597	73b623d4-6dbf-4090-bab0-ee57fb719cf6	1	2019-07-02
60760-597-28	EA - Each	60760-597	fffe644d-7794-49d6-8e4a-2868a45fab8d	1	2019-07-02
60760-597-30	EA - Each	60760-597	50dfd667-c125-47ef-a956-c1d6c1200296	1	2019-09-05
60760-597-40	EA - Each	60760-597	7bc0c160-9e26-47d0-91cb-82b13767ab99	1	2019-07-02
60760-597-60	EA - Each	60760-597	0b714f36-e699-4b1c-9de6-68c8b2b4b4ec	1	2019-07-02
60760-597-90	EA - Each	60760-597	52af5d35-c6fa-4d80-8817-2badae3112a5	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-597	IBUPROFEN TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]	9	Current NDC, Legacy NDC, 6 package rows	20250425_88dda062-2b9c-3632-e053-2a95a90a1431.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 · 36 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	88dd304f-1c64-08e3-e053-2a95a90a596f	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	ST. MARY'S MEDICAL PARK PHARMACY	88dda062-2b9c-3632-e053-2a95a90a1431	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329 ndc (product): 60760-597
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	60c731c6-4dc4-490a-8469-0b7e58e563a1	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	1ebf94fb-76b6-4c01-be1b-575062827545	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	0550fa2f-f25e-4abb-b10e-a3d05bdb3217	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	c38a03fa-6b9a-4737-a848-063ca5c580b9	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	8dba0ed8-feef-23a5-e053-2995a90aaff8	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Strides Pharma Science Limited	a266a3c6-932f-476f-ae93-48a785c92286	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	86577bf3-51c6-88e2-e053-2991aa0ac741	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Direct_Rx	40071818-5bf0-095b-e063-6294a90ad58a	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	06710aef-2631-4925-8e9e-33bae84b5912	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	3b9fdc48-c071-4e2c-e063-6294a90a679f	2025-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Asclemed USA, Inc.	d7ed42c4-371c-4a54-ab15-0630656f0427	2025-08-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	NCS HealthCare of KY, LLC dba Vangard Labs	ab11e142-9e11-4ce4-9671-7e4fe53ffe92	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	NCS HealthCare of KY, LLC dba Vangard Labs	f1842893-7a34-4f77-8231-55fb0c98b22b	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	3732defa-67c2-4b84-8a84-4bbc27b6cb24	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	689dbbe8-4f85-48fe-8efc-fda81b60d37f	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	09621787-9a5c-4abf-9ccd-d6f8d581738f	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	42b92fd7-468c-4fb8-9ff0-31296735df4c	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	7942cc53-1268-4e5f-8db0-f0b3524bb744	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197806	ibuprofen 600 MG Oral Tablet	PSN	88dda062-2b9c-3632-e053-2a95a90a1431	11
197806	ibuprofen 600 MG Oral Tablet	SCD	88dda062-2b9c-3632-e053-2a95a90a1431	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60760-597-20	60760059720	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-20)	2019-05-02	0000-00-00	No	No	Current
60760-597-28	60760059728	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-28)	2019-06-10	0000-00-00	No	No	Current
60760-597-30	60760059730	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-30)	2025-04-23	0000-00-00	No	No	Current
60760-597-40	60760059740	40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-40)	2019-05-02	0000-00-00	No	No	Current
60760-597-60	60760059760	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-60)	2019-06-12	0000-00-00	No	No	Current
60760-597-90	60760059790	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-90)	2024-04-26		No	No	Current