Ibuprofen

Product NDC: 59556-855
11-digit product format: 595560855
Labeler code: 59556
Product ID: 59556-855_1f4159ad-d58c-4519-932b-030cc2735514
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Strides Pharma Inc.
Application: ANDA091355
Marketing category: ANDA
Marketing start: 2011-04-04
Substance: IBUPROFEN
Active strength: 200 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: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091355-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-04-04

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Brand name suffix: Immediate Release
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 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
310965	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
1f4159ad-d58c-4519-932b-030cc2735514	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
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
59556-855-42	IbuprofenImmediate Release	10000 in 1 BAG	TABLET, COATED	10000	3
59556-855-06	IbuprofenImmediate Release	1 in 1 CARTON	TABLET, COATED	1	1
59556-855-06	IbuprofenImmediate Release	100 in 1 BOTTLE	TABLET, COATED	100	1
59556-855-07	IbuprofenImmediate Release	1 in 1 CARTON	TABLET, COATED	1	1
59556-855-07	IbuprofenImmediate Release	500 in 1 BOTTLE	TABLET, COATED	500	1
59556-855-08	IbuprofenImmediate Release	1000 in 1 BOTTLE	TABLET, COATED	1000	1
59556-855-08	IbuprofenImmediate Release	1 in 1 CARTON	TABLET, COATED	1	1
59556-855-25	IbuprofenImmediate Release	1 in 1 CARTON	TABLET, COATED	1	1
59556-855-25	IbuprofenImmediate Release	50 in 1 BOTTLE	TABLET, COATED	50	1
59556-855-41	IbuprofenImmediate Release	24 in 1 BOTTLE	TABLET, COATED	24	1
59556-855-41	IbuprofenImmediate Release	1 in 1 CARTON	TABLET, COATED	1	1
59556-855-44	IbuprofenImmediate Release	1 in 1 CARTON	TABLET, COATED	1	1
59556-855-44	IbuprofenImmediate Release	165 in 1 BOTTLE	TABLET, COATED	165	1
59556-855-46	IbuprofenImmediate Release	1000 in 1 BAG	TABLET, COATED	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59556-855	IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC]	3	Current NDC, Legacy NDC, 1 package rows	20240523_ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b.zip
59556-855	IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC.]	1	Current NDC, Legacy NDC, 13 package rows	20170601_1f4159ad-d58c-4519-932b-030cc2735514.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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	NUVICARE LLC	b063d2dc-d579-46e7-8cfc-1596c803c7f9	2026-07-29	Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355
Ibuprofen	IBUPROFEN	Pioneer Life Sciences, LLC	291602fa-8ebe-4200-bba7-9798c90f8a50	2026-07-29	Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355
Ibuprofen Immediate Release	IBUPROFEN	Strides Pharma Inc	ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b	2024-05-23	Boxed warning, Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355 ndc (product): 59556-855
Ibuprofen Immediate Release	IBUPROFEN	Strides Pharma Inc.	1f4159ad-d58c-4519-932b-030cc2735514	2017-05-26	Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355 ndc (product): 59556-855

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
310965	ibuprofen 200 MG Oral Tablet	PSN	ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b	3
310965	ibuprofen 200 MG Oral Tablet	SCD	ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b	3
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b	3
310965	ibuprofen 200 MG Oral Tablet	PSN	1f4159ad-d58c-4519-932b-030cc2735514	1
310965	ibuprofen 200 MG Oral Tablet	SCD	1f4159ad-d58c-4519-932b-030cc2735514	1
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	1f4159ad-d58c-4519-932b-030cc2735514	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59556-855-06	59556085506	1 BOTTLE in 1 CARTON (59556-855-06) / 100 TABLET, COATED in 1 BOTTLE	1 bottle	2011-04-04	0000-00-00	No	No	Current
59556-855-07	59556085507	1 BOTTLE in 1 CARTON (59556-855-07) / 500 TABLET, COATED in 1 BOTTLE	1 bottle	2011-04-04	0000-00-00	No	No	Current
59556-855-08	59556085508	1 BOTTLE in 1 CARTON (59556-855-08) / 1000 TABLET, COATED in 1 BOTTLE	1 bottle	2011-04-04	0000-00-00	No	No	Current
59556-855-25	59556085525	1 BOTTLE in 1 CARTON (59556-855-25) / 50 TABLET, COATED in 1 BOTTLE	1 bottle	2011-04-04	0000-00-00	No	No	Current
59556-855-41	59556085541	1 BOTTLE in 1 CARTON (59556-855-41) / 24 TABLET, COATED in 1 BOTTLE	1 bottle	2011-04-04	0000-00-00	No	No	Current
59556-855-42	59556085542	10000 TABLET, COATED in 1 BAG (59556-855-42)		2022-03-18	0000-00-00	No	No	Current
59556-855-44	59556085544	1 BOTTLE in 1 CARTON (59556-855-44) / 165 TABLET, COATED in 1 BOTTLE	1 bottle	2011-04-04	0000-00-00	No	No	Current
59556-855-46	59556085546	1000 TABLET, COATED in 1 BAG (59556-855-46)		2011-04-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets USP, 200 mg Drug Facts	Strides Pharma Inc \| Strides Pharma Global Pte. Ltd.	2024-05-23	HUMAN OTC DRUG LABEL	3
Drugs Facts	Strides Pharma Inc. \| Strides Shasun Limited	2017-05-26	Human OTC Drug Label	1