ibuprofen

Product NDC: 10267-3909
11-digit product format: 102673909
Labeler code: 10267
Product ID: 10267-3909_77cf0092-7436-14ba-e053-2991aa0ac112
Type: HUMAN OTC DRUG
Nonproprietary name: ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Contract Pharmacal Corp.
Application: ANDA071265
Marketing category: ANDA
Marketing start: 2014-01-15
Substance: IBUPROFEN
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071265-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1986-10-15
A071265-002	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1987-09-10

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071265-001	IBUPROFEN	200MG	TABLET / ORAL	1986-10-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071265-002	IBUPROFEN	200MG	TABLET / ORAL	1987-09-10	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310965	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
237bcb87-64a0-415b-bd53-e9d3b8bf33b6	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	Strength	SPL version
10267-3909-2	ibuprofen	250 in 1 BOTTLE	TABLET	250		13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [CONTRACT PHARMACAL CORPORATION]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10267-3909	IBUPROFEN TABLET [CONTRACT PHARMACAL CORP.]	13	Current NDC, Legacy NDC, 1 package rows	20181120_237bcb87-64a0-415b-bd53-e9d3b8bf33b6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ibuprofen	IBUPROFEN	Contract Pharmacal Corp.	237bcb87-64a0-415b-bd53-e9d3b8bf33b6	2018-11-07	Warnings	Exact identifier application applno (ANDA): 071265 application number: ANDA071265 ndc (product): 10267-3909

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	237bcb87-64a0-415b-bd53-e9d3b8bf33b6	13
310965	ibuprofen 200 MG Oral Tablet	SCD	237bcb87-64a0-415b-bd53-e9d3b8bf33b6	13
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	237bcb87-64a0-415b-bd53-e9d3b8bf33b6	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10267-3909-2	10267390902	250 TABLET in 1 BOTTLE (10267-3909-2)	250 tablet	2014-01-15	0000-00-00	No	No	Current