IBU

Product NDC: 55111-683
Requested package NDC: 55111-683-91
11-digit product format: 551110683
Labeler code: 55111
Product ID: 55111-683_a7977972-4353-9ca0-d419-e37039010e7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA075682
Marketing category: ANDA
Marketing start: 2008-11-20
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	55111-683	55111-683-91	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

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 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`

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	RLD / RS	Approval date
A075682-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14
A075682-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14
A075682-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075682-001	AB
A075682-002	AB
A075682-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-002	IBUPROFEN	600MG	TABLET / ORAL	AB		2001-11-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-003	IBUPROFEN	800MG	TABLET / ORAL	AB	RS	2001-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075682-001	IBUPROFEN	400MG	TABLET / ORAL	AB		2001-11-14	`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	A075682-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075682-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075682-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075682-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075682-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075682-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075682-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075682-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075682-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075682-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075682-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075682-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075682-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075682-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075682-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075682-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075682-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: IBU
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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197805	Internal RxNorm lookup
197806	Internal RxNorm lookup
197807	Internal RxNorm lookup
206905	Internal RxNorm lookup
206913	Internal RxNorm lookup
206917	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
24731405-219c-79b4-ecf0-7d5fbfda94ba	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
55111-683-01	IBU	100 in 1 BOTTLE	TABLET	100	15
55111-683-05	IBU	500 in 1 BOTTLE	TABLET	500	15
55111-683-09	IBU	90 in 1 BOTTLE	TABLET	90	15
55111-683-30	IBU	30 in 1 BOTTLE	TABLET	30	15
55111-683-50	IBU	50 in 1 BOTTLE	TABLET	50	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-683-01	EA - Each	55111-683	2389a362-4cad-43a6-a8bd-b9e86f0f79eb	1	2012-07-24
55111-683-05	EA - Each	55111-683	5a989e58-e9d3-4187-aea8-1597fb6a292d	1	2012-07-24
55111-683-09	EA - Each	55111-683	907136b0-db1d-419e-9342-d34422b91ff7	1	2012-07-24
55111-683-30	EA - Each	55111-683	b78d9c92-a0df-41bd-acda-258b80ea5102	1	2012-07-24
55111-683-50	EA - Each	55111-683	d47a6cf0-7501-44e5-97b9-7e08a2d98846	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	IBU (IBUPROFEN) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3242
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	16
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	16
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	16
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	16
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	16
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	6
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS, INC.]	5
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [STAT RX USA LLC]	4
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [STAT RX USA LLC]	4
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET [STAT RX USA LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [STAT RX USA LLC]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [STAT RX USA LLC]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET [STAT RX USA LLC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [STAT RX USA LLC]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN TABLET [STAT RX USA LLC]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [STAT RX USA LLC]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN TABLET [STAT RX USA LLC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [STAT RX USA LLC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [STAT RX USA LLC]	4
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
Polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	IBU (IBUPROFEN) TABLET [UNIT DOSE SERVICES]	3
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
COPOVIDONE	INACTIVE INGREDIENT	D9C330MD8B	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
Polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [APOTHECA, INC.]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [DIRECTRX]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [APOTHECA, INC.]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [DIRECTRX]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET [DIRECTRX]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET [APOTHECA, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [APOTHECA, INC.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [DIRECTRX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [APOTHECA, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [DIRECTRX]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET [APOTHECA, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET [DIRECTRX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [APOTHECA, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [DIRECTRX]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN TABLET [APOTHECA, INC.]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN TABLET [DIRECTRX]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [APOTHECA, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
Polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [DIRECTRX]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN TABLET [DIRECTRX]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [APOTHECA, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [DIRECTRX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [APOTHECA, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [DIRECTRX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [CONTRACT PHARMACY SERVICES-PA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-683	IBU (IBUPROFEN) TABLET [DR. REDDY'S LABORATORIES LIMITED]	14	Current NDC, Legacy NDC, 5 package rows	20241001_24731405-219c-79b4-ecf0-7d5fbfda94ba.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals, Inc.	72ec2491-924d-460f-9510-62d624d54b59	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Golden State Medical Supply, Inc.	bbf4821d-f9fc-9f6e-e053-2a95a90a5253	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	4522b794-5c93-44cd-e063-6394a90ab39a	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	45223597-0ea8-b275-e063-6394a90a8412	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	4522cb9e-4999-c455-e063-6294a90a294f	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Proficient Rx LP	a7098fa1-b5ae-485e-ada9-64154f81fb6a	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Golden State Medical Supply, Inc.	3ff501eb-5ae3-8824-e063-6394a90ac58e	2025-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	ba86e936-ef72-43e5-aebf-f2c788fe2266	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	8ea0e303-3967-4d71-8255-ac42a841ce28	2025-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Dr. Reddy's Laboratories Limited	24731405-219c-79b4-ecf0-7d5fbfda94ba	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682 ndc (product): 55111-683
IBU	IBU	RedPharm Drug, Inc.	4db219dc-ea48-490c-e054-00144ff88e88	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31e6005b-492e-7936-e063-6394a90ad801	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	31e6ac7a-fa3e-4dd4-e063-6294a90a29af	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	7650f84b-92f2-4065-8ef2-f5de5bd7002b	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	NuCare Pharmaceuticals,Inc.	593d9870-0213-75e6-e053-2991aa0a0eff	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	NuCare Pharmaceuticals Inc.	575c275c-3e1a-0572-e053-2991aa0adabd	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	NuCare Pharmaceuticals,Inc.	678e2d16-33f3-67a7-e053-2991aa0a1132	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Proficient Rx LP	ea6f626d-cda3-46e2-9ac9-4e72204cb726	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	b0f03994-b744-4d66-95b7-8c86217882bc	2021-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd	2021-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075682 application number: ANDA075682

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	ba86e936-ef72-43e5-aebf-f2c788fe2266	29
197806	ibuprofen 600 MG Oral Tablet	PSN	ba86e936-ef72-43e5-aebf-f2c788fe2266	29
197807	ibuprofen 800 MG Oral Tablet	PSN	ba86e936-ef72-43e5-aebf-f2c788fe2266	29
197805	ibuprofen 400 MG Oral Tablet	SCD	ba86e936-ef72-43e5-aebf-f2c788fe2266	29
197806	ibuprofen 600 MG Oral Tablet	SCD	ba86e936-ef72-43e5-aebf-f2c788fe2266	29
197807	ibuprofen 800 MG Oral Tablet	SCD	ba86e936-ef72-43e5-aebf-f2c788fe2266	29
197805	ibuprofen 400 MG Oral Tablet	PSN	72ec2491-924d-460f-9510-62d624d54b59	17
197806	ibuprofen 600 MG Oral Tablet	PSN	72ec2491-924d-460f-9510-62d624d54b59	17
197807	ibuprofen 800 MG Oral Tablet	PSN	72ec2491-924d-460f-9510-62d624d54b59	17
197805	ibuprofen 400 MG Oral Tablet	SCD	72ec2491-924d-460f-9510-62d624d54b59	17
197806	ibuprofen 600 MG Oral Tablet	SCD	72ec2491-924d-460f-9510-62d624d54b59	17
197807	ibuprofen 800 MG Oral Tablet	SCD	72ec2491-924d-460f-9510-62d624d54b59	17
206905	Ibu 400 MG Oral Tablet	PSN	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
206913	Ibu 600 MG Oral Tablet	PSN	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
206917	Ibu 800 MG Oral Tablet	PSN	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
197805	ibuprofen 400 MG Oral Tablet	PSN	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
197806	ibuprofen 600 MG Oral Tablet	PSN	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
197807	ibuprofen 800 MG Oral Tablet	PSN	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
206905	ibuprofen 400 MG Oral Tablet [Ibu]	SBD	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
206913	ibuprofen 600 MG Oral Tablet [Ibu]	SBD	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
206917	ibuprofen 800 MG Oral Tablet [Ibu]	SBD	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
197805	ibuprofen 400 MG Oral Tablet	SCD	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
197806	ibuprofen 600 MG Oral Tablet	SCD	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
197807	ibuprofen 800 MG Oral Tablet	SCD	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
206905	Ibu 400 MG Oral Tablet	SY	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
206913	Ibu 600 MG Oral Tablet	SY	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
206917	Ibu 800 MG Oral Tablet	SY	24731405-219c-79b4-ecf0-7d5fbfda94ba	15
206913	Ibu 600 MG Oral Tablet	PSN	f2a61c07-e9b7-4d18-acd5-d0ddbc5ce1b2	9
206913	Ibu 600 MG Oral Tablet	PSN	405074f3-9c1a-46cd-889e-76ec8966a556	9
206917	Ibu 800 MG Oral Tablet	PSN	405074f3-9c1a-46cd-889e-76ec8966a556	9
197806	ibuprofen 600 MG Oral Tablet	PSN	f2a61c07-e9b7-4d18-acd5-d0ddbc5ce1b2	9
197806	ibuprofen 600 MG Oral Tablet	PSN	405074f3-9c1a-46cd-889e-76ec8966a556	9
197807	ibuprofen 800 MG Oral Tablet	PSN	405074f3-9c1a-46cd-889e-76ec8966a556	9
206913	ibuprofen 600 MG Oral Tablet [Ibu]	SBD	405074f3-9c1a-46cd-889e-76ec8966a556	9
206913	ibuprofen 600 MG Oral Tablet [Ibu]	SBD	f2a61c07-e9b7-4d18-acd5-d0ddbc5ce1b2	9
206917	ibuprofen 800 MG Oral Tablet [Ibu]	SBD	405074f3-9c1a-46cd-889e-76ec8966a556	9
197806	ibuprofen 600 MG Oral Tablet	SCD	405074f3-9c1a-46cd-889e-76ec8966a556	9
197806	ibuprofen 600 MG Oral Tablet	SCD	f2a61c07-e9b7-4d18-acd5-d0ddbc5ce1b2	9
197807	ibuprofen 800 MG Oral Tablet	SCD	405074f3-9c1a-46cd-889e-76ec8966a556	9
206913	Ibu 600 MG Oral Tablet	SY	405074f3-9c1a-46cd-889e-76ec8966a556	9
206913	Ibu 600 MG Oral Tablet	SY	f2a61c07-e9b7-4d18-acd5-d0ddbc5ce1b2	9
206917	Ibu 800 MG Oral Tablet	SY	405074f3-9c1a-46cd-889e-76ec8966a556	9
206913	Ibu 600 MG Oral Tablet	PSN	a7098fa1-b5ae-485e-ada9-64154f81fb6a	8
197805	ibuprofen 400 MG Oral Tablet	PSN	908e725f-bd99-6d0b-e053-2995a90aefb2	8
197806	ibuprofen 600 MG Oral Tablet	PSN	a7098fa1-b5ae-485e-ada9-64154f81fb6a	8
197806	ibuprofen 600 MG Oral Tablet	PSN	908e725f-bd99-6d0b-e053-2995a90aefb2	8
206913	ibuprofen 600 MG Oral Tablet [Ibu]	SBD	a7098fa1-b5ae-485e-ada9-64154f81fb6a	8
197805	ibuprofen 400 MG Oral Tablet	SCD	908e725f-bd99-6d0b-e053-2995a90aefb2	8
197806	ibuprofen 600 MG Oral Tablet	SCD	a7098fa1-b5ae-485e-ada9-64154f81fb6a	8
197806	ibuprofen 600 MG Oral Tablet	SCD	908e725f-bd99-6d0b-e053-2995a90aefb2	8
206913	Ibu 600 MG Oral Tablet	SY	a7098fa1-b5ae-485e-ada9-64154f81fb6a	8
197805	ibuprofen 400 MG Oral Tablet	PSN	0396bfec-afe1-460c-8141-e8ad877b4bc0	7
197806	ibuprofen 600 MG Oral Tablet	PSN	0396bfec-afe1-460c-8141-e8ad877b4bc0	7
197807	ibuprofen 800 MG Oral Tablet	PSN	0396bfec-afe1-460c-8141-e8ad877b4bc0	7
197805	ibuprofen 400 MG Oral Tablet	SCD	0396bfec-afe1-460c-8141-e8ad877b4bc0	7
197806	ibuprofen 600 MG Oral Tablet	SCD	0396bfec-afe1-460c-8141-e8ad877b4bc0	7
197807	ibuprofen 800 MG Oral Tablet	SCD	0396bfec-afe1-460c-8141-e8ad877b4bc0	7
197806	ibuprofen 600 MG Oral Tablet	PSN	4db219dc-ea48-490c-e054-00144ff88e88	6
197806	ibuprofen 600 MG Oral Tablet	SCD	4db219dc-ea48-490c-e054-00144ff88e88	6
206913	Ibu 600 MG Oral Tablet	PSN	575c275c-3e1a-0572-e053-2991aa0adabd	4
197805	ibuprofen 400 MG Oral Tablet	PSN	9c9541af-3221-4e6c-a1eb-fae64925a488	4
197806	ibuprofen 600 MG Oral Tablet	PSN	575c275c-3e1a-0572-e053-2991aa0adabd	4
197806	ibuprofen 600 MG Oral Tablet	PSN	9c9541af-3221-4e6c-a1eb-fae64925a488	4
197807	ibuprofen 800 MG Oral Tablet	PSN	9c9541af-3221-4e6c-a1eb-fae64925a488	4
206913	ibuprofen 600 MG Oral Tablet [Ibu]	SBD	575c275c-3e1a-0572-e053-2991aa0adabd	4
197805	ibuprofen 400 MG Oral Tablet	SCD	9c9541af-3221-4e6c-a1eb-fae64925a488	4
197806	ibuprofen 600 MG Oral Tablet	SCD	9c9541af-3221-4e6c-a1eb-fae64925a488	4
197806	ibuprofen 600 MG Oral Tablet	SCD	575c275c-3e1a-0572-e053-2991aa0adabd	4
197807	ibuprofen 800 MG Oral Tablet	SCD	9c9541af-3221-4e6c-a1eb-fae64925a488	4
206913	Ibu 600 MG Oral Tablet	SY	575c275c-3e1a-0572-e053-2991aa0adabd	4
206913	Ibu 600 MG Oral Tablet	PSN	f941e6ca-1bd8-45df-89f9-94203347fec0	2
206913	Ibu 600 MG Oral Tablet	PSN	0d4ce1a2-835b-4837-a76c-6bac61219136	2
197805	ibuprofen 400 MG Oral Tablet	PSN	c9ccbafa-99de-49f0-9946-3877bfdc3d7c	2
197806	ibuprofen 600 MG Oral Tablet	PSN	c9ccbafa-99de-49f0-9946-3877bfdc3d7c	2
197806	ibuprofen 600 MG Oral Tablet	PSN	f941e6ca-1bd8-45df-89f9-94203347fec0	2
197806	ibuprofen 600 MG Oral Tablet	PSN	0d4ce1a2-835b-4837-a76c-6bac61219136	2
197806	ibuprofen 600 MG Oral Tablet	PSN	908e725f-bd90-6d0b-e053-2995a90aefb2	2
197807	ibuprofen 800 MG Oral Tablet	PSN	c9ccbafa-99de-49f0-9946-3877bfdc3d7c	2
206913	ibuprofen 600 MG Oral Tablet [Ibu]	SBD	f941e6ca-1bd8-45df-89f9-94203347fec0	2
206913	ibuprofen 600 MG Oral Tablet [Ibu]	SBD	0d4ce1a2-835b-4837-a76c-6bac61219136	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
55111-683-91	55111068391	2000 TABLET in 1 POUCH (55111-683-91)	2000 tablet	10-DEC-24	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IBU ™ Tablets	Preferred Pharmaceuticals, Inc.	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	17
IBU ™ Ibuprofen Tablets	Golden State Medical Supply, Inc.	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	6
IBU ™ Tablets	Proficient Rx LP	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	8
IBU ™ Tablets	Major Pharmaceuticals	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	29
IBU ™ Tablets	Dr. Reddy's Laboratories Limited \| Dr. Reddy's Laboratories Limited-FTO-3	2025-07-02	HUMAN PRESCRIPTION DRUG LABEL	15
IBU - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2025-04-09	HUMAN PRESCRIPTION DRUG LABEL	6
IBU 600 MG	Lake Erie Medical DBA Quality Care Products LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	32459
IBU - NuCare Pharmaceuticals Inc.	NuCare Pharmaceuticals Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	4
IBU ™ Tablets	Medsource Pharmaceuticals \| Dr. Reddy's Laboratories Louisiana, LLC \| Dr. Reddy's Laboratories Limited-FTO-3	2024-03-14	HUMAN PRESCRIPTION DRUG LABEL	1
IBU ™ Tablets	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	9
ibuprofen	Direct_Rx	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	8
IBU ™ Tablets	NuCare Pharmaceuticals,Inc.	2022-01-14	HUMAN PRESCRIPTION DRUG LABEL	3
IBU ™ Tablets	Aphena Pharma Solutions - Tennessee, LLC	2021-01-21	HUMAN PRESCRIPTION DRUG LABEL	1
ibuprofen	Direct_Rx	2021-01-12	HUMAN PRESCRIPTION DRUG LABEL	2
IBUPROFEN	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	7
IBU ™ Tablets	St. Mary's Medical Park Pharmacy \| Dr. Reddy's Laboratories Louisiana, LLC	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	5
IBU ™ Tablets	NuCare Pharmaceuticals, Inc.	2020-01-14	HUMAN PRESCRIPTION DRUG LABEL	2
IBU ™ Tablets	Golden State Medical Supply, Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	4
IBU ™ Tablets	NCS HealthCare of KY, Inc dba Vangard Labs	2019-07-18	HUMAN PRESCRIPTION DRUG LABEL	5
IBU ™ Tablets	A-S Medication Solutions	2019-06-25	HUMAN PRESCRIPTION DRUG LABEL	2
IBU ™ Tablets	A-S Medication Solutions	2019-06-13	HUMAN PRESCRIPTION DRUG LABEL	2
IBU ™ Tablets	REMEDYREPACK INC.	2019-03-29	HUMAN PRESCRIPTION DRUG LABEL	4
PharmapureRx ® IBU 600-EZS™ (ibuprofen, pill swallowing spray) Rx Only	PureTek Corporation	2019-03-06	HUMAN PRESCRIPTION DRUG LABEL	2
IBU ™ Tablets	Unit Dose Services	2017-09-06	HUMAN PRESCRIPTION DRUG LABEL	9

IBU