Application 210149

Type: ANDA
Sponsor: GUARDIAN DRUG

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210149-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2018-08-17

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210149-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2018-08-17	`e64feba35796…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Ibuprofen Bubblegum Dye Free	IBUPROFEN	CVS	2cf2f35b-5d66-e3ff-e063-6294a90a9b45	2026-06-16	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen 572	IBUPROFEN	Family Dollar Services, Inc.	1a2182df-4339-442d-9c61-98c8b01e36fa	2025-12-03	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Family Dollar Services, Inc.	137a0290-822a-842d-e063-6294a90a5c18	2025-12-03	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Dye Free Childrens Ibuprofen	IBUPROFEN	CVS	2cf2a4de-29d3-8af5-e063-6294a90a9cee	2025-05-01	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Discount Drug Mart, Inc	2d58d1c4-b864-6bb8-e063-6394a90a7117	2025-02-24	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Harris Teeter, LLC	2bb186c8-f791-5f1f-e063-6294a90a87ff	2025-02-04	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	e210c707-2bae-44a5-93dc-459dd24fd960	2023-11-20	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	c7e59784-a338-4922-a806-98c7505957cd	2023-11-10	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen	IBUPROFEN	Chain Drug Marketing Association Inc.	ba0baba6-a7f9-4e4c-88f7-c7fbecc61f25	2023-10-25	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149
Childrens Ibuprofen bubblegum	IBUPROFEN	Guardian Drug Company	9cb92af9-a829-4f54-b8f5-4e5cb4f165b7	2021-10-13	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149 ndc (product): 53041-572 ndc (product): 53041-632 ndc (product): 53041-639 ndc (product): 53041-638
Childrens Ibuprofen	IBUPROFEN	Guardian Drug Company	694866ce-c419-4b4c-bfb2-4175703d89f1	2018-09-07	Warnings	Exact identifier application applno (ANDA): 210149 application number: ANDA210149 ndc (product): 53041-634

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53041-572	Childrens Ibuprofen bubblegum	Ibuprofen	Guardian Drug Company	ANDA	Current
53041-632	Childrens Ibuprofen fruit	Ibuprofen	Guardian Drug Company	ANDA	Current
53041-634	Childrens Ibuprofen	Ibuprofen	Guardian Drug Company	ANDA	Current
53041-638	Childrens Ibuprofen blue raspberry	Ibuprofen	Guardian Drug Company	ANDA	Current
53041-639	Childrens Ibuprofen grape	Ibuprofen	Guardian Drug Company	ANDA	Current