Ibuprofen

Product NDC: 60760-596
11-digit product format: 607600596
Labeler code: 60760
Product ID: 60760-596_55a7deb0-1b72-0741-e063-6394a90a29f5
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: 2019-04-29
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: 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 · 12 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
2025-02-02 03:52 UTC · source 2025-01-31	60760-596-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	60760-596-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	60760-596-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	60760-596-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	60760-596-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	60760-596-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	60760-596-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	60760-596-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	60760-596-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	60760-596-20	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	60760-596-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	60760-596-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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 · 129 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
2026-09-14 22:38:34	2026-08	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078329-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2009-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078329-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2009-02-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078329-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2009-02-05	`caaa826d4ba7…`
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…`

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	A078329-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078329-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078329-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078329-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078329-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078329-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	800 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
197807	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
88dd304f-1c64-08e3-e053-2a95a90a596f	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
60760-596-09	Ibuprofen	9 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	9	7
60760-596-20	Ibuprofen	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	7
60760-596-30	Ibuprofen	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	7
60760-596-60	Ibuprofen	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	7
60760-596-90	Ibuprofen	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-596-09	EA - Each	60760-596	0a16fd83-1c13-42e4-96cc-6e271c13319f	1	2025-06-13
60760-596-20	EA - Each	60760-596	a0491892-b9cf-4463-8463-f4d15a1e2395	1	2019-07-02
60760-596-30	EA - Each	60760-596	616eb695-1c81-4087-9e51-f6edbe4a727e	1	2019-07-02
60760-596-60	EA - Each	60760-596	91572111-65e7-470b-9c2b-b5e3471db40c	1	2019-09-05
60760-596-90	EA - Each	60760-596	83b8bca2-6ee9-4963-a03f-1db427540b78	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60760-596	IBUPROFEN TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]	6	Current NDC, Legacy NDC, 5 package rows	20250515_88dd304f-1c64-08e3-e053-2a95a90a596f.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 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31f59d10-d821-2291-e063-6294a90ac518	2025-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	3140a614-c7ae-3062-e063-6394a90ad3d7	2025-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	SOLA Pharmaceuticals, LLC	b19b8c34-e0c1-4982-92fc-34dbe7384935	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	1361b6d6-0443-460a-8446-41f63a1e28df	2024-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	92efad86-31ae-78e5-e053-2995a90a0fda	2024-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	a2160213-2a32-2044-e053-2995a90a21af	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	8c3dccbb-1084-cd09-e053-2a95a90ac12a	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	8cb93e5f-4ebc-24b7-e053-2a95a90a5a23	2024-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	88795f0e-41b7-504e-e053-2995a90a3b9e	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals NY LLC	e07d989d-1b0e-4cc1-abf2-93c8b208a29a	2023-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	A-S Medication Solutions	7152b6ce-6113-4003-bf80-aa263be69392	2023-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	A-S Medication Solutions	400faee1-f662-470e-bcd6-7711dfaf9ba2	2023-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	91723661-d0bb-4498-ac59-59bbdc334230	2022-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078329 application number: ANDA078329
Ibuprofen	IBUPROFEN	Proficient Rx LP	8813a8a4-ebbd-4204-88a3-600a92ea9170	2020-12-01	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
197807	ibuprofen 800 MG Oral Tablet	PSN	88dd304f-1c64-08e3-e053-2a95a90a596f	7
197807	ibuprofen 800 MG Oral Tablet	SCD	88dd304f-1c64-08e3-e053-2a95a90a596f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60760-596-09	60760059609	9 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-596-09)	2025-05-13		No	No	Current
60760-596-20	60760059620	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-596-20)	2019-04-29	0000-00-00	No	No	Current
60760-596-30	60760059630	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-596-30)	2019-05-13	0000-00-00	No	No	Current
60760-596-60	60760059660	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-596-60)	2019-07-22	0000-00-00	No	No	Current
60760-596-90	60760059690	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-596-90)	2019-04-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen tablets Strides Shasun Limited	St. Mary's Medical Park Pharmacy	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	9