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 20 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Rite Aid Corporation	1dba3cb7-2e3d-4378-93cf-92db8f24f41f	2025-10-09	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
RIGHT REMEDIES Ibuprofen 200 MG	IBUPROFEN	Strive Pharmaceuticals Inc.	5c155210-d16f-487e-983d-c7b0f97365c6	2025-10-08	Warnings	Name fallback generic name: IBUPROFEN
Childrens Motrin	IBUPROFEN	Kenvue Brands LLC	63ec7636-bf2a-4d52-ab88-fb93d41661ec	2025-10-08	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	6521bc47-4d9c-4a5b-b109-3841f3be4b6c	2025-10-07	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Motrin	IBUPROFEN	Kenvue Brands LLC	15b0b56d-6188-4937-b541-902022e35b24	2025-10-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	bfda6547-19b2-4230-87a1-a68fbec740b4	2025-10-06	Warnings	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Kenvue Brands LLC	d21129f8-4d96-4e36-bc39-a534306dd77e	2025-10-03	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PHOENIX RX LLC	40202c76-4275-88fd-e063-6394a90a07b2	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
careone ibuprofen	IBUPROFEN	American Sales Company	2720b8aa-4361-4cd4-be26-aa6dd1692d12	2025-10-01	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	a1a5a9c7-c727-4e41-a8f0-2982f796a3ca	2025-09-29	Warnings	Name fallback generic name: IBUPROFEN
leader ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	96da60f7-06a9-438a-ae59-8609fdd1587d	2025-09-25	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Kroger Company	bc173f1b-2e44-2c2e-e053-2a95a90a89c4	2025-09-24	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Kroger Company	bbedfc37-913d-8046-e053-2995a90af68a	2025-09-24	Warnings	Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
pain relief	IBUPROFEN	Meijer, Inc.	ae39917e-1998-4298-8686-919c0d3c2b07	2025-09-19	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	7acdd557-0b6c-48f5-9437-7bc567af1f85	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension Dye Free	IBUPROFEN	FSA Store Inc. (Caring Mill)	099e374b-49c2-4d56-a047-d4f0c4af34ba	2025-09-18	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	06710aef-2631-4925-8e9e-33bae84b5912	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	86fc38bc-7f54-4aab-9c4d-d0898a4381f9	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	d50f829d-071f-4299-9b74-0f28caac7118	2025-09-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ibuprofen generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Meijer Distribution Inc	e28e64dc-5f4e-4260-953a-3de38a5eaa76	2025-09-15	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