Application 065444

Type: ANDA
Sponsor: HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEPHALEXIN	CEPHALEXIN	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	No	No
002	CEPHALEXIN	CEPHALEXIN	FOR SUSPENSION;ORAL	EQ 250MG BASE/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065444-001	CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL			2009-08-28
A065444-002	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL			2009-08-28

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 3 · 82 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	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`782e0a99824c…`

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 8 · 155 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	AvKARE	03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	88426cb3-1c0c-439b-9f1a-aa169040c29f	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	a6b5edf2-1ef8-46b7-977a-8c303900f3f0	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	655f38e8-1c4d-4cbc-9f52-bb881f065b2d	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	0384c418-b4d4-4c06-9ed9-13e864b1980b	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	d6954168-9c7f-4a6c-9262-2e6bed5c9f24	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	7508351d-69fe-457c-b450-9a2343be2587	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	980b9dd9-cb61-4c4f-81ac-85ee5a7c2497	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	759c3856-8d3a-4036-926c-8508b573c736	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	5b9b212a-3a3e-4637-b23c-6d66d8cf1171	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	11cfefee-d75e-430c-8817-02dc57de0e88	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	43ca66ae-2ada-412d-bc5d-f53602f535a5	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	cf1c5d03-eddc-463a-84ad-4d59362c2cf8	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	HAWAII REPACK, INC.	d54abc0a-3c8f-4f02-bd55-406f0c5b925a	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Northwind Health Company, LLC	1d0d50ba-8c2c-855c-e063-6394a90a5c7d	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Northwind Health Company, LLC	4ecf9314-76e2-c270-e063-6294a90ad8db	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	e54df878-c235-4aa3-af33-fe5287c73138	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Ascend Laboratories, LLC	4fec8daf-6e09-4153-926f-64709dbdd26c	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	b3bb8222-161e-4d9c-8e08-7e22ad65bf72	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	8499aa5a-49b1-4555-bd27-6177d92b261d	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9769	Cephalexin	Cephalexin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9769	Cephalexin	Cephalexin	West-ward Pharmaceutical	ANDA	Current
0143-9769	Cephalexin	Cephalexin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9769	Cephalexin	Cephalexin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9770	Cephalexin	Cephalexin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9770	Cephalexin	Cephalexin	West-ward Pharmaceutical	ANDA	Current
0143-9770	Cephalexin	Cephalexin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9770	Cephalexin	Cephalexin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
68289-008	Cephalexin	Cephalexin	Jazeera Pharmaceutical	ANDA	Current
68289-009	Cephalexin	Cephalexin	Jazeera Pharmaceutical	ANDA	Current