Ibuprofen

Product NDC: 53746-465
11-digit product format: 537460465
Labeler code: 53746
Product ID: 53746-465_769cfd1d-35d7-4f1a-ad8b-1bf642e02075
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA078558
Marketing category: ANDA
Marketing start: 2009-11-23
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: 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078558-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18
A078558-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18
A078558-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078558-001	AB
A078558-002	AB
A078558-003	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	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`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	A078558-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078558-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078558-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078558-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078558-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078558-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078558-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078558-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078558-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078558-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078558-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078558-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078558-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078558-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078558-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078558-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078558-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197805	Internal RxNorm lookup
197806	Internal RxNorm lookup
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
faebc392-0fd9-4c71-8471-beba10dda022	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
53746-465-01	Ibuprofen	100 in 1 BOTTLE	TABLET	100	26
53746-465-05	Ibuprofen	500 in 1 BOTTLE	TABLET	500	26
53746-465-30	Ibuprofen	30 in 1 BOTTLE	TABLET	30	26
53746-465-50	Ibuprofen	50 in 1 BOTTLE	TABLET	50	26
53746-465-60	Ibuprofen	60 in 1 BOTTLE	TABLET	60	26
53746-465-90	Ibuprofen	90 in 1 BOTTLE	TABLET	90	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53746-465-01	EA - Each	53746-465	ac443d16-7ca8-45b4-9aaa-9c1e3cdc7ca6	1	2012-07-24
53746-465-05	EA - Each	53746-465	751bbe79-a9c8-4572-8322-f97f537e6749	1	2012-07-24
53746-465-50	EA - Each	53746-465	ca9be8df-ff1e-4f9f-845d-b0b76cb60e23	1	2012-07-24
53746-465-60	EA - Each	53746-465	27adb98f-622d-4722-9399-76060453a642	1	2012-07-24
53746-465-90	EA - Each	53746-465	5acad6dd-23af-4ac4-8995-981f066c78d9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [BRYANT RANCH PREPACK]	1000
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [BRYANT RANCH PREPACK]	1000
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE INGREDIENT	2ACZ6IPC6I	THERAPROFEN-90 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	12
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	THERAPROFEN-90 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	12
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE MOIETY	2ACZ6IPC6I	THERAPROFEN-90 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	12
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	THERAPROFEN-90 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	THERAPROFEN-90 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	12
GELATIN	INACTIVE INGREDIENT	2G86QN327L	THERAPROFEN-90 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THERAPROFEN-90 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	12
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	THERAPROFEN-90 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	12
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	8
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [MCKESSON PACKAGING SERIVCES A BUSINESS UNIT OF MCKESSON CORPORATION]	7
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [MCKESSON PACKAGING SERIVCES A BUSINESS UNIT OF MCKESSON CORPORATION]	7
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET, FILM COATED [STAT RX USA LLC]	5
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE INGREDIENT	2ACZ6IPC6I	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [PROFICIENT RX LP]	4
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE MOIETY	2ACZ6IPC6I	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [PROFICIENT RX LP]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
TRICALCIUM PHOSPHATE	INACTIVE INGREDIENT	K4C08XP666	THERAPROFEN-60 (IBUPROFEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	4
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	3
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [KELTMAN PHARMACEUTICALS INC.]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [PD-RX PHARMACEUTICALS, INC.]	3
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [AIDAREX PHARMACEUTICALS LLC]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [DISPENSING SOLUTIONS, INC.]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [TYA PHARMACEUTICALS]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [AVKARE, INC.]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [AIDAREX PHARMACEUTICALS LLC]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [DISPENSING SOLUTIONS, INC.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [TYA PHARMACEUTICALS]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [AVKARE, INC.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [H.J. HARKINS COMPANY, INC.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [AMERICAN HEALTH PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [PHYSICIANS TOTAL CARE, INC.]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [MEDVANTX, INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [REBEL DISTRIBUTORS CORP]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [DIRECT RX]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [ALTURA PHARMACEUTICALS, INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [ALTURA PHARMACEUTICALS, INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [DIRECT RX]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [MEDVANTX, INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [DISPENSING SOLUTIONS, INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [A-S MEDICATION SOLUTIONS LLC]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [REBEL DISTRIBUTORS CORP]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [REDPHARM DRUG INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53746-465	IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	26	Current NDC, Legacy NDC, 6 package rows	20241222_faebc392-0fd9-4c71-8471-beba10dda022.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals LLC	17577b3b-e755-45d1-8b53-775d058578b2	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	0387bfaa-daca-48ec-b718-0216a848c16a	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	PHOENIX RX LLC	40202c76-4275-88fd-e063-6394a90a07b2	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	American Health Packaging	e080f7da-a506-4c04-a227-c1be77234f01	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	334e40f3-6da4-ecbe-e063-6294a90a35bf	2025-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fc871659-ce41-1be6-e053-6294a90aa5e4	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	af9af7f4-6314-6217-e053-2995a90a5a0f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	faebc392-0fd9-4c71-8471-beba10dda022	2024-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558 ndc (product): 53746-465
Ibuprofen	IBUPROFEN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1a02fa34-b5ae-7183-e063-6294a90a3ae4	2024-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	e90c573d-eb0f-45a5-94d1-efdd3d2b7a11	2024-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	A-S Medication Solutions	fa99f5ec-0306-473b-827f-86cd0a7978ec	2023-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Proficient Rx LP	e4bb22bb-6df6-4016-a023-0b454df9fb0b	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Proficient Rx LP	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558

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
197805	ibuprofen 400 MG Oral Tablet	PSN	faebc392-0fd9-4c71-8471-beba10dda022	26
197806	ibuprofen 600 MG Oral Tablet	PSN	faebc392-0fd9-4c71-8471-beba10dda022	26
197807	ibuprofen 800 MG Oral Tablet	PSN	faebc392-0fd9-4c71-8471-beba10dda022	26
197805	ibuprofen 400 MG Oral Tablet	SCD	faebc392-0fd9-4c71-8471-beba10dda022	26
197806	ibuprofen 600 MG Oral Tablet	SCD	faebc392-0fd9-4c71-8471-beba10dda022	26
197807	ibuprofen 800 MG Oral Tablet	SCD	faebc392-0fd9-4c71-8471-beba10dda022	26
197806	ibuprofen 600 MG Oral Tablet	PSN	334fa37b-f73a-459a-9f67-281022273fed	12
197806	ibuprofen 600 MG Oral Tablet	SCD	334fa37b-f73a-459a-9f67-281022273fed	12
197805	ibuprofen 400 MG Oral Tablet	PSN	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197806	ibuprofen 600 MG Oral Tablet	PSN	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197807	ibuprofen 800 MG Oral Tablet	PSN	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197805	ibuprofen 400 MG Oral Tablet	SCD	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197806	ibuprofen 600 MG Oral Tablet	SCD	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197807	ibuprofen 800 MG Oral Tablet	SCD	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	9
197805	ibuprofen 400 MG Oral Tablet	PSN	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197806	ibuprofen 600 MG Oral Tablet	PSN	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197807	ibuprofen 800 MG Oral Tablet	PSN	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197805	ibuprofen 400 MG Oral Tablet	SCD	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197806	ibuprofen 600 MG Oral Tablet	SCD	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197807	ibuprofen 800 MG Oral Tablet	SCD	207ebbc7-eae4-45f3-9ae3-4845479632ad	7
197806	ibuprofen 600 MG Oral Tablet	PSN	d7422259-dafa-4d33-ac9f-936e3e756cab	5
197807	ibuprofen 800 MG Oral Tablet	PSN	d7422259-dafa-4d33-ac9f-936e3e756cab	5
197806	ibuprofen 600 MG Oral Tablet	SCD	d7422259-dafa-4d33-ac9f-936e3e756cab	5
197807	ibuprofen 800 MG Oral Tablet	SCD	d7422259-dafa-4d33-ac9f-936e3e756cab	5
197805	ibuprofen 400 MG Oral Tablet	PSN	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197806	ibuprofen 600 MG Oral Tablet	PSN	b720c99f-feaa-4453-ba4a-c3377501f7b8	4
197806	ibuprofen 600 MG Oral Tablet	PSN	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197807	ibuprofen 800 MG Oral Tablet	PSN	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197805	ibuprofen 400 MG Oral Tablet	SCD	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197806	ibuprofen 600 MG Oral Tablet	SCD	b720c99f-feaa-4453-ba4a-c3377501f7b8	4
197806	ibuprofen 600 MG Oral Tablet	SCD	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197807	ibuprofen 800 MG Oral Tablet	SCD	e31d4be3-e542-43a1-a6e3-4f6937a003ae	4
197806	ibuprofen 600 MG Oral Tablet	PSN	a75f4230-cd5e-4fd9-b97e-31893c10e981	3
197807	ibuprofen 800 MG Oral Tablet	PSN	a75f4230-cd5e-4fd9-b97e-31893c10e981	3
197806	ibuprofen 600 MG Oral Tablet	SCD	a75f4230-cd5e-4fd9-b97e-31893c10e981	3
197807	ibuprofen 800 MG Oral Tablet	SCD	a75f4230-cd5e-4fd9-b97e-31893c10e981	3
197805	ibuprofen 400 MG Oral Tablet	PSN	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197805	ibuprofen 400 MG Oral Tablet	PSN	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197805	ibuprofen 400 MG Oral Tablet	PSN	c22b75cb-c744-4233-bbf8-b220526daad8	2
197805	ibuprofen 400 MG Oral Tablet	PSN	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197805	ibuprofen 400 MG Oral Tablet	PSN	187eb9c7-3c96-4bb0-b3fc-d4aaded34d3c	2
197806	ibuprofen 600 MG Oral Tablet	PSN	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197806	ibuprofen 600 MG Oral Tablet	PSN	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197806	ibuprofen 600 MG Oral Tablet	PSN	e8aaf5c2-40ef-44f8-acd4-f69e303a60d1	2
197806	ibuprofen 600 MG Oral Tablet	PSN	40c5dd26-8f05-41d9-aa21-f0713b2fbfe3	2
197806	ibuprofen 600 MG Oral Tablet	PSN	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197806	ibuprofen 600 MG Oral Tablet	PSN	366536da-fb9a-4ed1-84db-10d69d9247f2	2
197806	ibuprofen 600 MG Oral Tablet	PSN	187eb9c7-3c96-4bb0-b3fc-d4aaded34d3c	2
197806	ibuprofen 600 MG Oral Tablet	PSN	c22b75cb-c744-4233-bbf8-b220526daad8	2
197807	ibuprofen 800 MG Oral Tablet	PSN	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197807	ibuprofen 800 MG Oral Tablet	PSN	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197807	ibuprofen 800 MG Oral Tablet	PSN	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197807	ibuprofen 800 MG Oral Tablet	PSN	366536da-fb9a-4ed1-84db-10d69d9247f2	2
197807	ibuprofen 800 MG Oral Tablet	PSN	c22b75cb-c744-4233-bbf8-b220526daad8	2
197805	ibuprofen 400 MG Oral Tablet	SCD	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197805	ibuprofen 400 MG Oral Tablet	SCD	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197805	ibuprofen 400 MG Oral Tablet	SCD	c22b75cb-c744-4233-bbf8-b220526daad8	2
197805	ibuprofen 400 MG Oral Tablet	SCD	187eb9c7-3c96-4bb0-b3fc-d4aaded34d3c	2
197805	ibuprofen 400 MG Oral Tablet	SCD	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197806	ibuprofen 600 MG Oral Tablet	SCD	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197806	ibuprofen 600 MG Oral Tablet	SCD	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197806	ibuprofen 600 MG Oral Tablet	SCD	e8aaf5c2-40ef-44f8-acd4-f69e303a60d1	2
197806	ibuprofen 600 MG Oral Tablet	SCD	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197806	ibuprofen 600 MG Oral Tablet	SCD	40c5dd26-8f05-41d9-aa21-f0713b2fbfe3	2
197806	ibuprofen 600 MG Oral Tablet	SCD	366536da-fb9a-4ed1-84db-10d69d9247f2	2
197806	ibuprofen 600 MG Oral Tablet	SCD	187eb9c7-3c96-4bb0-b3fc-d4aaded34d3c	2
197806	ibuprofen 600 MG Oral Tablet	SCD	c22b75cb-c744-4233-bbf8-b220526daad8	2
197807	ibuprofen 800 MG Oral Tablet	SCD	b6847040-4624-449b-bff5-c3cd0f5786c1	2
197807	ibuprofen 800 MG Oral Tablet	SCD	366536da-fb9a-4ed1-84db-10d69d9247f2	2
197807	ibuprofen 800 MG Oral Tablet	SCD	aee5ffdc-0fe4-4a74-8b0a-7009d72c3506	2
197807	ibuprofen 800 MG Oral Tablet	SCD	8a187e32-4db8-4cd2-b619-f97c9b312d5a	2
197807	ibuprofen 800 MG Oral Tablet	SCD	c22b75cb-c744-4233-bbf8-b220526daad8	2
197805	ibuprofen 400 MG Oral Tablet	PSN	c6c3b8b0-4932-4cee-af0b-f14425925c50	1
197805	ibuprofen 400 MG Oral Tablet	PSN	940f3140-fe00-4297-ba81-f49bc3a3ace0	1
197806	ibuprofen 600 MG Oral Tablet	PSN	02850d0f-ded5-4d27-a377-17bbaa3e70a6	1
197806	ibuprofen 600 MG Oral Tablet	PSN	940f3140-fe00-4297-ba81-f49bc3a3ace0	1
197806	ibuprofen 600 MG Oral Tablet	PSN	c6c3b8b0-4932-4cee-af0b-f14425925c50	1
197807	ibuprofen 800 MG Oral Tablet	PSN	940f3140-fe00-4297-ba81-f49bc3a3ace0	1
197807	ibuprofen 800 MG Oral Tablet	PSN	7261a535-6d82-4e92-ac82-f1f2653b2966	1
197807	ibuprofen 800 MG Oral Tablet	PSN	c6c3b8b0-4932-4cee-af0b-f14425925c50	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53746-465-01	53746046501	100 TABLET in 1 BOTTLE (53746-465-01)	100 tablet	2009-11-23	0000-00-00	No	No	Current
53746-465-05	53746046505	500 TABLET in 1 BOTTLE (53746-465-05)	500 tablet	2009-11-23	0000-00-00	No	No	Current
53746-465-30	53746046530	30 TABLET in 1 BOTTLE (53746-465-30)	30 tablet	2009-11-23	0000-00-00	No	No	Current
53746-465-50	53746046550	50 TABLET in 1 BOTTLE (53746-465-50)	50 tablet	2009-11-23	0000-00-00	No	No	Current
53746-465-60	53746046560	60 TABLET in 1 BOTTLE (53746-465-60)	60 tablet	2009-11-23	0000-00-00	No	No	Current
53746-465-90	53746046590	90 TABLET in 1 BOTTLE (53746-465-90)	90 tablet	2009-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, USP (600 mg) Rx Only	PD-Rx Pharmaceuticals, Inc.	2025-02-27	HUMAN PRESCRIPTION DRUG LABEL	21
Ibuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals, LLC	2024-07-29	HUMAN PRESCRIPTION DRUG LABEL	26
Ibuprofen Tablets, USP (600 mg) Rx Only	PD-Rx Pharmaceuticals, Inc.	2021-12-02	HUMAN PRESCRIPTION DRUG LABEL	19
Ibuprofen Tablets, USP RX Only	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	9
Ibuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2020-11-09	HUMAN PRESCRIPTION DRUG LABEL	15
Ibuprofen Tablets, USP Rx Only	AvKARE, Inc.	2020-05-12	HUMAN PRESCRIPTION DRUG LABEL	10
IBUPROFEN TABLETS, USP	American Health Packaging	2020-04-14	HUMAN PRESCRIPTION DRUG LABEL	7
Ibuprofen Tablets, USP RX Only	REMEDYREPACK INC.	2020-04-06	HUMAN PRESCRIPTION DRUG LABEL	4
Ibuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only	Aphena Pharma Solutions - Tennessee, Inc.	2019-12-26	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP RX Only	Bryant Ranch Prepack	2018-09-07	HUMAN PRESCRIPTION DRUG LABEL	1003
Ibuprofen Tablets, USP RX Only	QPharma Inc \| Amneal Pharmaceuticals of New York, LLC \| Denton Pharma, Inc.	2018-03-14	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP RX Only	A-S Medication Solutions	2017-09-14	HUMAN PRESCRIPTION DRUG LABEL	8
Ibuprofen Tablets, USP RX Only	Preferred Pharmaceuticals, Inc.	2017-01-26	HUMAN PRESCRIPTION DRUG LABEL	4
IBUPROFEN	Direct Rx	2016-05-31	HUMAN PRESCRIPTION DRUG LABEL	7
Ibuprofen Tablets, USP	NCS HealthCare of KY, Inc dba Vangard Labs	2016-01-19	HUMAN PRESCRIPTION DRUG LABEL	9
Ibuprofen	Northwind Pharmaceuticals, LLC	2015-05-18	HUMAN PRESCRIPTION DRUG LABEL	3
Ibuprofen Tablets, USP	Blenheim Pharmacal, Inc.	2015-04-10	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP RX Only	TYA Pharmaceuticals	2013-08-20	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-07-02	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP	Aidarex Pharmaceuticals LLC	2012-09-06	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP	STAT Rx USA LLC \| PSS World Medical Inc.	2012-02-08	HUMAN PRESCRIPTION DRUG LABEL	5
Ibuprofen Tablets, USP	Rebel Distributors Corp	2011-12-13	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP	H.J. Harkins Company, Inc. \| Amneal Pharmaceuticals	2011-12-08	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP	Dispensing Solutions, Inc.	2011-10-07	HUMAN PRESCRIPTION DRUG LABEL	1
Theraprofen-90	Physician Therapeutics LLC \| Amneal Pharmaceuticals \| H.J. Harkins Company, Inc \| Targeted Medical Pharma Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	12