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N050440-001	KEFLET	CEPHALEXIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982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N050440-003	KEFLET	CEPHALEXIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26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N050440-001	KEFLET	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`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N050440-003	KEFLET	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26	`84e616aacf4f…`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N050440-001	KEFLET	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`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 7 of 8 · 151 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	4fccce5a-4e39-46cd-976a-32ff71189520	2024-03-08	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	92be9844-0775-4808-bdeb-dccb09647d91	2024-03-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
cephalexin	CEPHALEXIN	A-S Medication Solutions	d31da5be-c939-4aa0-adb8-b26a1396b228	2024-02-22	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	0edeb103-5e94-4f42-828f-c7336486c784	2024-02-15	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af10128f-021a-14b7-e053-2a95a90a4365	2024-01-18	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	f501f3a9-48e9-451a-a4b6-46d268b7bd3d	2024-01-18	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	8d25d863-9ec2-4b76-b2e5-d4e2e39639a5	2024-01-18	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Advanced Rx Pharmacy of Tennessee, LLC	b6ffe633-dd91-6d49-e053-2a95a90a5ac6	2024-01-17	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	9a1f2ab7-d8af-444f-96c2-56b666d4c79a	2024-01-15	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	ea10d05a-2e39-4a30-8935-5555bc1e515e	2024-01-15	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	ab3fc544-3652-4de5-a7ff-e013adb69b5a	2024-01-09	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	f957ea27-2906-40c7-ac03-eb2f742473a0	2023-12-28	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	ee0603a5-0758-4968-89e3-1aa95e9967f2	2023-12-12	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	7cbdfa7f-2ea0-48e1-b506-59f58e5685a6	2023-12-11	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	18518154-30ba-48a4-852a-3a7723030071	2023-12-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
cephalexin	CEPHALEXIN	Proficient Rx LP	829244bd-93da-4a5a-a257-890cfec4c06d	2023-12-01	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Major Pharmaceuticals	1c1fbad7-bef4-42a0-a8c9-b35168f5d533	2023-11-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	2cb7bc3a-988b-4414-8036-fb09b2ab5767	2023-10-23	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	b270d537-878b-4468-b246-b704adb29ced	2023-10-23	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Teva Pharmaceuticals USA, Inc.	445b2a87-2e4f-483a-abe8-26fefd67514a	2023-10-01	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN

Reported adverse events (FAERS/openFDA)#

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