Ibuprofen

Product NDC: 65162-356
11-digit product format: 651620356
Labeler code: 65162
Product ID: 65162-356_53da63da-f301-44dc-902c-2c288304929f
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA202300
Marketing category: ANDA
Marketing start: 2013-03-29
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 42.

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
A202300-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2011-12-23

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202300-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2011-12-23	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Brand name suffix: Pain Reliever/Fever Reducer
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
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
877440fc-3afb-4123-a2e6-5cb48c74413c	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
65162-356-02	IbuprofenPain Reliever/Fever Reducer	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	11
65162-356-02	IbuprofenPain Reliever/Fever Reducer	20 in 1 BOTTLE	CAPSULE, LIQUID FILLED	20	11
65162-356-11	IbuprofenPain Reliever/Fever Reducer	1000 in 1 BOTTLE	CAPSULE, LIQUID FILLED	1000	11
65162-356-50	IbuprofenPain Reliever/Fever Reducer	500 in 1 BOTTLE	CAPSULE, LIQUID FILLED	500	11
65162-356-69	IbuprofenPain Reliever/Fever Reducer	80 in 1 BOTTLE	CAPSULE, LIQUID FILLED	80	11
65162-356-69	IbuprofenPain Reliever/Fever Reducer	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-356	IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS LLC]	11	Current NDC, Legacy NDC, 6 package rows	20241027_877440fc-3afb-4123-a2e6-5cb48c74413c.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 Pain Reliever/Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals LLC	877440fc-3afb-4123-a2e6-5cb48c74413c	2024-10-25	Warnings	Exact identifier application applno (ANDA): 202300 application number: ANDA202300 ndc (product): 65162-356
Ibuprofen Pain Reliever/Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals LLC	5f27dd3f-c735-417b-95e6-26dc5aae5a7a	2024-10-25	Warnings	Exact identifier application applno (ANDA): 202300 application number: ANDA202300
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	7d544d8e-fa76-461f-9417-5f1873912eac	2023-05-15	Warnings	Exact identifier application applno (ANDA): 202300 application number: ANDA202300
Ibuprofen	IBUPROFEN	P & L Development, LLC	1889faea-24a3-45ea-92de-8dc76b9ed5b4	2023-04-25	Warnings	Exact identifier application applno (ANDA): 202300 application number: ANDA202300

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	877440fc-3afb-4123-a2e6-5cb48c74413c	11
310964	ibuprofen 200 MG Oral Capsule	SCD	877440fc-3afb-4123-a2e6-5cb48c74413c	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-356-02	65162035602	1 BOTTLE in 1 CARTON (65162-356-02) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2013-03-29	0000-00-00	No	No	Current
65162-356-11	65162035611	1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-11)		2013-03-29	0000-00-00	No	No	Current
65162-356-50	65162035650	500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-50)		2013-03-29	0000-00-00	No	No	Current
65162-356-69	65162035669	1 BOTTLE in 1 CARTON (65162-356-69) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2013-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Capsules (liquid filled, 200 mg)	Amneal Pharmaceuticals LLC	2024-10-25	HUMAN OTC DRUG LABEL	11