Sunmark ibuprofen ib

Product NDC: 49348-927
Requested package NDC: 49348-927-10
11-digit product format: 493480927
Labeler code: 49348
Product ID: 49348-927_ef713d42-5595-487a-869f-c704f0ba0a7f
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA077349
Marketing category: ANDA
Marketing start: 2006-03-20
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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
excluded package	package	49348-927	49348-927-10	D	Discontinued by firm		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 · 9 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077349-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL		RS	2005-06-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-927-09	EA - Each	49348-927	2e010f5e-df00-4208-8975-13b47d69fde3	1	2020-04-20
49348-927-10	EA - Each	49348-927	ce614f25-4dd6-4c20-a6df-a6093f951f08	1	2018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	SUNMARK IBUPROFEN IB (IBUPROFEN) TABLET, COATED [MCKESSON]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	SUNMARK IBUPROFEN IB (IBUPROFEN) TABLET, COATED [MCKESSON]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SUNMARK IBUPROFEN IB (IBUPROFEN) TABLET, COATED [MCKESSON]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SUNMARK IBUPROFEN IB (IBUPROFEN) TABLET, COATED [MCKESSON]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SUNMARK IBUPROFEN IB (IBUPROFEN) TABLET, COATED [MCKESSON]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SUNMARK IBUPROFEN IB (IBUPROFEN) TABLET, COATED [MCKESSON]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SUNMARK IBUPROFEN IB (IBUPROFEN) TABLET, COATED [MCKESSON]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SUNMARK IBUPROFEN IB (IBUPROFEN) TABLET, COATED [MCKESSON]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SUNMARK IBUPROFEN IB (IBUPROFEN) TABLET, COATED [MCKESSON]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SUNMARK IBUPROFEN IB (IBUPROFEN) TABLET, COATED [MCKESSON]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SUNMARK IBUPROFEN IB (IBUPROFEN) TABLET, COATED [MCKESSON]	1

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	H E B	21567c0f-abba-4a40-a0b9-5ce49b3d9648	2026-07-28	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Select Consumer Group LLC	52c650cf-3085-7b2c-e063-6394a90a797f	2026-05-27	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
CareOne Ibuprofen	IBUPROFEN	American Sales Company	03cdff8a-8890-440d-82b5-54ce809f88cc	2026-02-03	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB, TRAVEL BASIX	IBUPROFEN	Lil' Drug Store Products, Inc.	c2b99756-3e03-4d9f-9ce6-7db879afe3a1	2025-12-10	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Ibuprofen	IBUPROFEN	CVS Pharmacy	93f8101c-1cf7-4cb0-9c00-c57c9f9023c8	2025-10-26	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Kenvue Brands LLC	d21129f8-4d96-4e36-bc39-a534306dd77e	2025-10-03	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
leader ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	96da60f7-06a9-438a-ae59-8609fdd1587d	2025-09-25	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
ibuprofen	IBUPROFEN	Publix Super Markets Inc	c5cd3843-8d72-4850-bebe-4ac54e4f43fa	2025-08-21	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
ibuprofen 200	IBUPROFEN	Walgreen Company	49a3d51d-55d1-4b80-ab7b-35c27a937cb9	2025-07-02	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Topcare ibuprofen	IBUPROFEN	Topco Associates LLC	479a0c97-dbd9-47ad-9910-9dd4edf5136f	2025-07-02	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Morning Star OTC	e69f00c4-b8ec-4a83-9eea-8cb2835ad776	2025-06-19	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
MOTRIN IB	IBUPROFEN	JC World Bell Wholesale Co., Inc.	4e7516e1-184a-45e9-b908-228121f163f6	2024-12-27	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
kirkland signature ibuprofen ib	IBUPROFEN	Costco Wholesale Company	2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c	2024-10-14	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
dg health ibuprofen	IBUPROFEN	Dolgencorp Inc	b514b589-d965-4a21-91b3-fab4019e9d96	2024-04-12	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	5ada3dbe-af87-49db-a6b0-0a1c02111cbf	2024-03-11	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
signature care ibuprofen	IBUPROFEN	Safeway	95904b21-752d-48b4-a882-8d81d2384e1f	2024-02-01	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Good Neighbor Pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	74b227c9-8341-44df-a763-cfeb371c0d28	2023-08-17	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Good Sense ibuprofen	IBUPROFEN	L. Perrigo Company	aebae4b3-18c8-4ecf-b578-1fe7cc50076b	2023-06-28	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Equate Ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	153bc4ac-427d-426a-9bb8-665487e4b169	2023-04-27	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Jones Healthcare Group - Packaging Services, Inc	6419cc78-27d4-7713-e053-2a91aa0a5a10	2022-04-29	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-927-10	49348092710	1 BOTTLE in 1 CARTON (49348-927-10) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2006-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Ibuprofen IB Drug Facts	Strategic Sourcing Services LLC	2022-11-17	HUMAN OTC DRUG LABEL	4