Application 074937

Type: ANDA
Sponsor: PERRIGO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S IBUPROFEN	IBUPROFEN	SUSPENSION;ORAL	100MG/5ML	No	No

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
A074937-001	CHILDREN'S IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1998-12-22

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`cb3db0bc1861…`

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 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
childrens ibuprofen	IBUPROFEN	Rite Aid Corporation	26bccfc1-bc8d-4241-a078-c760048951c9	2026-07-24	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen	IBUPROFEN	ATLANTIC BIOLOGICALS CORP.	3ce7549f-e4db-9f89-e063-6294a90a126d	2026-07-10	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Rite Aid Corporation	1da544eb-ed4e-4124-bea3-f827f1322270	2026-05-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	52d3e633-13a2-cdcd-e063-6394a90ac189	2026-05-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen	IBUPROFEN	Rite Aid Corporation	69ca781a-202e-4579-91e6-f32a22ccc22c	2026-05-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen childrens	IBUPROFEN	Walgreen Company	f67612e8-38f3-4d1c-889b-57995a2f9f66	2026-05-15	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
care one ibuprofen	IBUPROFEN	American Sales Company	d26d2766-6d4c-462b-ae8b-ef8d87acd633	2026-04-16	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937 ndc (product): 41520-897
Childrens Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	9291857c-30b3-414b-99e1-9c127e72c0d4	2026-04-16	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937 ndc (product): 55154-1577
Ibuprofen childrens	IBUPROFEN	HyVee Inc	55f8def6-f7de-4b3e-a92a-5cd9e68a46a1	2026-04-15	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937 ndc (product): 42507-660
CHILDRENS Ibuprofen	IBUPROFEN	Kesin Pharma Corporation	436c0126-4ff3-c082-e063-6294a90a3d72	2026-04-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen childrens	IBUPROFEN	HyVee Inc	3d8497c6-1c46-4248-b75c-b086591529cc	2026-04-10	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937 ndc (product): 42507-166
Ibuprofen	IBUPROFEN	CVS Pharmacy	ef204cc0-4009-4dd0-83e2-2b5ad6f98409	2026-02-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
equate ibuprofen childrens	IBUPROFEN	Wal-Mart Stores Inc	7817923f-4c21-4943-a7e2-dad4e2915fc4	2026-02-23	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937 ndc (product): 49035-166
ibuprofen	IBUPROFEN	HyVee Inc	c20a9bc5-e481-4fb2-ad10-d01e83e43ca0	2026-02-21	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937 ndc (product): 42507-897
Ibuprofen Childrens	IBUPROFEN	Major Pharmaceuticals	9d56e64d-7860-4fd1-88d2-c537e50079d8	2026-02-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
childrens ibuprofen	IBUPROFEN	HyVee Inc	d522a3ac-dd43-4faa-b3f8-69313be1c829	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937 ndc (product): 42507-685
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	847758ed-66fc-4db9-8fdb-78f3c3291a03	2026-01-26	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
good sense ibuprofen childrens	IBUPROFEN	Preferred Pharmaceuticals Inc.	7ac61180-d668-4eec-b04f-d14f7b552a4d	2025-12-23	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
topcare childrens ibuprofen	IBUPROFEN	Topco Associates LLC	d1bb68a6-3a29-4a4e-b4e9-413cc8d16191	2025-12-12	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	a1a5a9c7-c727-4e41-a8f0-2982f796a3ca	2025-09-29	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 233 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
37808-897	rx act ibuprofen	Ibuprofen	H E B	ANDA	Current
37808-897	rx act ibuprofen	Ibuprofen	H E B	ANDA	Current
41163-166	Equaline ibuprofen	Ibuprofen	Supervalu Inc	ANDA	Current
41163-685	Equaline Ibuprofen	Ibuprofen	Supervalu Inc	ANDA	Current
41163-897	equaline ibuprofen	Ibuprofen	Supervalu Inc	ANDA	Current
41190-166	ShopRite Childrens Ibuprofen	Ibuprofen	Wakefern Food Corporation	ANDA	Current
41190-660	ShopRite Childrens Ibuprofen	Ibuprofen	Wakefern Food Corporation	ANDA	Current
41190-660	ShopRite Childrens Ibuprofen	Ibuprofen	Wakefern Food Corporation	ANDA	Current
41190-897	ShopRite Ibuprofen	Ibuprofen	Wakefern Food Corporation	ANDA	Current
41250-240	childrens ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-240	childrens ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-419	Childrens Ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-419	Childrens Ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-626	childrens ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-626	childrens ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-660	ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-660	ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-660	ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-685	childrens ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-685	childrens ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-897	ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-897	ibuprofen	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41250-911	childrens ibuprofen oral suspension	Ibuprofen	Meijer Distribution Inc	ANDA	Current
41520-166	care one ibuprofen	Ibuprofen	American Sales Company	ANDA	Current
41520-166	care one ibuprofen	Ibuprofen	American Sales Company	ANDA	Current
41520-660	care one ibuprofen	Ibuprofen	American Sales Company	ANDA	Current
41520-685	Care One ibuprofen	Ibuprofen	American Sales Company	ANDA	Current
41520-897	care one ibuprofen	Ibuprofen	American Sales Company	ANDA	Current
42254-117	good sense ibuprofen	Ibuprofen	Rebel Distributors Corp	ANDA	Current
42507-166	ibuprofen	Ibuprofen	HyVee Inc	ANDA	Current
42507-660	Ibuprofen	Ibuprofen	HyVee Inc	ANDA	Current
42507-685	Ibuprofen	Ibuprofen	HyVee Inc	ANDA	Current
42507-685	Ibuprofen	Ibuprofen	HyVee Inc	ANDA	Current
42507-897	ibuprofen	Ibuprofen	HyVee Inc	ANDA	Current
45802-133	Childrens Ibuprofen	Ibuprofen	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-133	Childrens Ibuprofen	Ibuprofen	Perrigo New York Inc	ANDA	Current
45802-140	Childrens Ibuprofen	Ibuprofen	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-140	Childrens Ibuprofen	Ibuprofen	Perrigo New York Inc	ANDA	Current
45802-897	ibuprofen	Ibuprofen	Perrigo New York Inc	ANDA	Current
45802-897	ibuprofen	Ibuprofen	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
46122-110	good neighbor pharmacy childrens ibuprofen	Ibuprofen	Amerisource Bergen	ANDA	Current
46994-897	being well ibuprofen	Ibuprofen	Save-A-Lot Food Stores Ltd	ANDA	Current
46994-897	being well ibuprofen	Ibuprofen	Save-A-Lot Food Stores Ltd	ANDA	Current
46994-897	being well ibuprofen	Ibuprofen	Save-A-Lot Food Stores Ltd	ANDA	Current
49035-166	equate ibuprofen	Ibuprofen	Wal-Mart Stores Inc	ANDA	Current
49035-660	equate ibuprofen	Ibuprofen	Wal-Mart Stores Inc	ANDA	Current
49035-897	equate ibuprofen	Ibuprofen	Wal-Mart Stores Inc	ANDA	Current
49348-229	sunmark ibuprofen	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49348-229	sunmark ibuprofen	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49348-229	sunmark ibuprofen	Ibuprofen	McKesson	ANDA	Current
49348-499	Sunmark ibuprofen	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49348-499	Sunmark ibuprofen	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49348-499	Sunmark ibuprofen	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49348-499	Sunmark ibuprofen	Ibuprofen	McKesson	ANDA	Current
49348-500	Sunmark ibuprofen	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49348-500	Sunmark ibuprofen	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49348-500	Sunmark ibuprofen	Ibuprofen	McKesson	ANDA	Current
49348-876	Sunmark ibuprofen	Ibuprofen	McKesson	ANDA	Current
49348-876	Sunmark ibuprofen	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49348-876	Sunmark ibuprofen	Ibuprofen	Strategic Sourcing Services LLC	ANDA	Current
49738-166	Smart Sense ibuprofen	Ibuprofen	Kmart Corporation	ANDA	Current
49738-685	Smart Sense ibuprofen	Ibuprofen	Kmart Corporation	ANDA	Current
49738-897	smart sense ibuprofen	Ibuprofen	Kmart Corporation	ANDA	Current
50090-3227	CHILDRENS IBUPROFEN	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-3408	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50090-3408	Ibuprofen	Ibuprofen	A-S Medication Solutions	ANDA	Current
50594-018	Sound Body Childrens Ibuprofen	Ibuprofen	Big Lots Stores, Inc.	ANDA	Current
52959-298	Ibuprofen	Ibuprofen	H.J. Harkins Company, Inc.	ANDA	Current
55154-1577	Childrens Ibuprofen	Ibuprofen	Cardinal Health 107, LLC	ANDA	Current
55154-1577	Childrens Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55154-1585	Childrens Ibuprofen	Ibuprofen	Cardinal Health	ANDA	Current
55312-685	childrens ibuprofen	Ibuprofen	Western Family Foods Inc	ANDA	Current
55316-166	Healthy Accents ibuprofen	Ibuprofen	DZA Brands LLC	ANDA	Current
55316-897	healthy accents ibuprofen	Ibuprofen	DZA Brands LLC	ANDA	Current
55319-166	family wellness childrens ibuprofen	Ibuprofen	Family Dollar Services Inc	ANDA	Current
55319-166	family wellness childrens ibuprofen	Ibuprofen	Family Dollar Services Inc	ANDA	Current
55319-166	family wellness childrens ibuprofen	Ibuprofen	Family Dollar Services Inc	ANDA	Current
55319-897	family wellness childrens ibuprofen	Ibuprofen	Family Dollar Services Inc	ANDA	Current
55319-897	family wellness childrens ibuprofen	Ibuprofen	Family Dollar Services Inc	ANDA	Current
55910-102	dg health childrens ibuprofen	Ibuprofen	Dolgencorp, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39446	ORIG	1998-12-22
22386	ORIG	1998-12-22
8469	ORIG	1998-12-22