Application 050440

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KEFLET	CEPHALEXIN	TABLET;ORAL	EQ 500MG BASE	No	No
002	KEFLET	CEPHALEXIN	TABLET;ORAL	EQ 1GM BASE	No	No
003	KEFLET	CEPHALEXIN	TABLET;ORAL	EQ 250MG BASE	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	RLD / RS	Approval date
N050440-001	KEFLET	CEPHALEXIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N050440-002	KEFLET	CEPHALEXIN	EQ 1GM BASE	TABLET / ORAL	Approved before 1982
N050440-003	KEFLET	CEPHALEXIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050440-001	KEFLET	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050440-003	KEFLET	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050440-001	KEFLET	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050440-003	KEFLET	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050440-001	KEFLET	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050440-003	KEFLET	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050440-001	KEFLET	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050440-003	KEFLET	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050440-001	KEFLET	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050440-003	KEFLET	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050440-001	KEFLET	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050440-003	KEFLET	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050440-001	KEFLET	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050440-003	KEFLET	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050440-001	KEFLET	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050440-003	KEFLET	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL	RLD	1987-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL	RLD	1987-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL	RLD	1987-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`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 5 of 8 · 151 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af4abf8b-22cc-da58-e053-2a95a90aa766	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	8e28f049-6110-4473-830f-c494191a7197	2024-12-20	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	American Health Packaging	cb64cab2-5297-4ed2-a50a-2e5d5e14fa8d	2024-12-17	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	a8f14231-5d43-46f7-ba1f-d6de8162d5e7	2024-11-20	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	99ef59d5-bc44-4727-86fe-dc81357207c3	2024-10-25	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	65b38519-1d8a-4aca-b415-c64cca84d085	2024-10-25	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Ascend Laboratories, LLC	36882c6d-7b6f-41e3-8c54-e3b0073b8c07	2024-10-18	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Chartwell RX, LLC.	3c459965-2d42-488b-80c4-ce801f94839c	2024-10-14	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	e46059e1-3ce9-4a3c-80ce-464b140600ce	2024-09-28	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals, Inc.	216660f3-0329-ef7d-e063-6294a90a17df	2024-09-05	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	fe6fff2f-f95c-4057-a71b-7ef6c5d415cc	2024-09-03	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	e186afb5-7531-45ea-b785-c230483a7747	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	f1439d25-3d3d-4fe5-b6e7-d76e62892969	2024-08-15	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	549bf887-1ef6-6a75-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	31afe835-8ec8-4ac0-8a2a-c3e9283fa6ea	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	8a691ff2-eb16-4357-87ee-0ac9c99a5cb7	2024-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	9694f7a6-bcec-4809-b261-cdd3740968cb	2024-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Proficient Rx LP	e43271ef-c145-4145-b7f0-a02c237de2b5	2024-08-02	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	28fec572-e3b9-448c-8626-5c0920f38eeb	2024-07-30	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	df6bb893-e3d7-4c8f-8cec-35b4d2fa33b3	2024-07-26	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN

Reported adverse events (FAERS/openFDA)#

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