IBUPROFEN

Product NDC: 59556-764
11-digit product format: 595560764
Labeler code: 59556
Product ID: 59556-764_7d889b12-7d30-423f-a988-bb1d201ebb59
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Strides Pharma Inc
Application: ANDA204469
Marketing category: ANDA
Marketing start: 2022-11-16
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: 2027-12-31
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
A204469-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2018-03-28

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	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204469-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-03-28	`cb3db0bc1861…`

Additional Listing Data#

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

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
310964	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
69b208ff-83f5-40d1-a2ff-d54b390e46e4	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
59556-764-11	IBUPROFEN	120 in 1 BOTTLE	CAPSULE, LIQUID FILLED	120	9
59556-764-11	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	9
59556-764-12	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	9
59556-764-12	IBUPROFEN	40 in 1 BOTTLE	CAPSULE, LIQUID FILLED	40	9
59556-764-13	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	9
59556-764-13	IBUPROFEN	80 in 1 BOTTLE	CAPSULE, LIQUID FILLED	80	9
59556-764-18	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	9
59556-764-18	IBUPROFEN	180 in 1 BOTTLE	CAPSULE, LIQUID FILLED	180	9
59556-764-29	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	9
59556-764-29	IBUPROFEN	20 in 1 BOTTLE	CAPSULE, LIQUID FILLED	20	9
59556-764-48	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	9
59556-764-48	IBUPROFEN	160 in 1 BOTTLE	CAPSULE, LIQUID FILLED	160	9
59556-764-49	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	9
59556-764-49	IBUPROFEN	200 in 1 BOTTLE	CAPSULE, LIQUID FILLED	200	9
59556-764-50	IBUPROFEN	300 in 1 BOTTLE	CAPSULE, LIQUID FILLED	300	9
59556-764-50	IBUPROFEN	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	9
59556-764-92	IBUPROFEN	3000 in 1 BAG	CAPSULE, LIQUID FILLED	3000	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59556-764	IBUPROFEN CAPSULE, LIQUID FILLED [STRIDES PHARMA INC]	8	Current NDC, Legacy NDC, 17 package rows	20240417_69b208ff-83f5-40d1-a2ff-d54b390e46e4.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	faabb11a-6fa0-492d-85cc-74ff8175b0b3	2026-07-01	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469
Basic Care Ibuprofen	IBUPROFEN	Amazon.com Services LLC	4c1a1543-a2a2-43fb-901c-cf6bcc374a3f	2026-06-03	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469
BASIC CARE IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	ae50a548-dc32-4c5b-b133-c6537267127b	2026-03-11	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469
IBUPROFEN	IBUPROFEN	Strides Pharma Inc	69b208ff-83f5-40d1-a2ff-d54b390e46e4	2026-01-08	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469 ndc (product): 59556-764
DG Health Ibuprofen	IBUPROFEN	Dolgencorp Inc	1dd4ffc5-3132-419b-8e70-78a7bb71da62	2026-01-02	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469
Foster and Thrive Ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	cf330b44-2d69-4f9f-99eb-2caa80aca873	2025-07-08	Warnings	Exact identifier application applno (ANDA): 204469 application number: ANDA204469

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
310964	ibuprofen 200 MG Oral Capsule	PSN	69b208ff-83f5-40d1-a2ff-d54b390e46e4	9
310964	ibuprofen 200 MG Oral Capsule	SCD	69b208ff-83f5-40d1-a2ff-d54b390e46e4	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59556-764-11	59556076411	1 BOTTLE in 1 CARTON (59556-764-11) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2022-11-16	0000-00-00	No	No	Current
59556-764-12	59556076412	1 BOTTLE in 1 CARTON (59556-764-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2022-11-16	0000-00-00	No	No	Current
59556-764-13	59556076413	1 BOTTLE in 1 CARTON (59556-764-13) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2022-11-16	0000-00-00	No	No	Current
59556-764-18	59556076418	1 BOTTLE in 1 CARTON (59556-764-18) / 180 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2022-11-16		No	No	Current
59556-764-29	59556076429	1 BOTTLE in 1 CARTON (59556-764-29) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2022-11-16	0000-00-00	No	No	Current
59556-764-48	59556076448	1 BOTTLE in 1 CARTON (59556-764-48) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2022-11-16	0000-00-00	No	No	Current
59556-764-49	59556076449	1 BOTTLE in 1 CARTON (59556-764-49) / 200 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2022-11-16	0000-00-00	No	No	Current
59556-764-50	59556076450	1 BOTTLE in 1 CARTON (59556-764-50) / 300 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2022-11-16	0000-00-00	No	No	Current
59556-764-92	59556076492	3000 CAPSULE, LIQUID FILLED in 1 BAG (59556-764-92)		2022-11-16		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION	Strides Pharma Inc	2026-01-08	HUMAN OTC DRUG LABEL	9