Application 204062

Type: ANDA
Sponsor: HEC PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	TABLET;ORAL	400MG	No	No
002	IBUPROFEN	IBUPROFEN	TABLET;ORAL	600MG	No	No
003	IBUPROFEN	IBUPROFEN	TABLET;ORAL	800MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A204062-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10
A204062-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10
A204062-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204062-002	IBUPROFEN	600MG	TABLET / ORAL	2018-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204062-003	IBUPROFEN	800MG	TABLET / ORAL	2018-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204062-001	IBUPROFEN	400MG	TABLET / ORAL	2018-09-10	`301d65b070ca…`

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 11 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Lidl US LLC	b840e98e-be1b-496f-9f0d-3a1a55eb9fe4	2026-04-08	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
good sense childrens ibuprofen	IBUPROFEN	L. Perrigo Company	19253175-4185-468d-9d3d-9b53be764e18	2026-04-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	0ef4913b-5dc3-45bc-9cef-58601f8d2a79	2026-04-07	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen Dye-Free	IBUPROFEN	Wal-Mart Stores Inc	23cb5001-6aeb-434a-b2e8-aaf8bbab9dc6	2026-04-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	1ebf94fb-76b6-4c01-be1b-575062827545	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN ORAL	Aurobindo Pharma Limited	758eeb45-e599-4c1a-969d-8fa33f27bf14	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen
Ibuprofen Dye Free	IBUPROFEN	WALMART INC.	2b04d255-a1df-4698-9b5a-ad7a12205e1b	2026-03-25	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	32edaf34-046e-4ded-8bee-493a0019d6bd	2026-03-25	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	dda7645f-1666-4c1f-b974-01add2ea79ac	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
IBUPROFEN Infants	IBUPROFEN	Sun Pharmaceutical Industries, Inc.	bc816597-a85a-4143-9f99-bb0699ca57c5	2026-03-23	Warnings	Name fallback generic name: IBUPROFEN
Dolex Flex	IBUPROFEN	Pharmadel LLC	0543420d-a250-065d-e063-6294a90a005e	2026-03-20	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Westminster Pharmaceuticals, LLC	6f7e255f-48c9-4366-8725-7f8cbe1bb75a	2026-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	2e0f74a5-b8f3-fc81-e063-6394a90a647a	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NorthStar Rx LLC	aeee629b-255c-40d8-8e95-779aec00f723	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Grocery Outlet, Inc.	44660e1d-79c2-34ce-e063-6294a90ade3f	2026-03-17	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
CounterAct IB	IBUPROFEN	Melaleuca, Inc	7fafc13e-3fee-ace3-e053-2a91aa0ac2ea	2026-03-17	Boxed warning, Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	Advagen Pharma Ltd.	4b8b06f3-8557-4645-af27-c0819e163b79	2026-03-12	Warnings	Name fallback generic name: IBUPROFEN
ADVIL	IBUPROFEN	Haleon US Holdings LLC	1a665e64-9f30-be37-4a83-38789f1f1e89	2026-03-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Walgreen Company	86818ad6-fd45-4635-9ce8-eac986f008aa	2026-03-11	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Discount Drug Mart	d0ebf2a7-551b-4acd-be60-2d0b936dd703	2026-03-11	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48792-7811	Ibuprofen	Ibuprofen	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7812	Ibuprofen	Ibuprofen	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7813	Ibuprofen	Ibuprofen	Sunshine Lake Pharma Co., Ltd.	ANDA	Current