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 44.

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N050440-001	KEFLET	CEPHALEXIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982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N050440-003	KEFLET	CEPHALEXIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-26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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050440-003	KEFLET	EQ 250MG BASE	TABLET / ORAL		1987-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050440-001	KEFLET	EQ 500MG BASE	TABLET / ORAL	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050440-002	KEFLET	EQ 1GM BASE	TABLET / ORAL	Approved before 1982		`c0c555d07b60…`

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 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	e54df878-c235-4aa3-af33-fe5287c73138	2026-09-14	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Northwind Health Company, LLC	4ecf9314-76e2-c270-e063-6294a90ad8db	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	c0ca008e-0e28-412e-a58f-70f63817713b	2026-09-01	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Lupin Pharmaceuticals, Inc.	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	HAWAII REPACK, INC.	d54abc0a-3c8f-4f02-bd55-406f0c5b925a	2026-08-18	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	864d2046-b2c8-415c-814b-512bc4901c76	2026-08-12	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	c600a2c0-42ab-4be8-b9b1-59ba39494b3f	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	af3e9919-3812-4917-bb6e-266a692ee4ab	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	a24a3c7c-c0f8-4107-ab30-751bea743d2d	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	3dc725a0-6e4b-45c6-9569-34ef65455845	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	e4e1ebcf-b43b-4dbe-9295-eeef67ba6272	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	b73593ce-0b1f-4371-bae1-140742de3b42	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	d3527c0a-94e4-46a2-be77-d936abcd19ec	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	AvKARE	03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	88426cb3-1c0c-439b-9f1a-aa169040c29f	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	a6b5edf2-1ef8-46b7-977a-8c303900f3f0	2026-07-22	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	655f38e8-1c4d-4cbc-9f52-bb881f065b2d	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	0384c418-b4d4-4c06-9ed9-13e864b1980b	2026-07-16	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	d6954168-9c7f-4a6c-9262-2e6bed5c9f24	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	7508351d-69fe-457c-b450-9a2343be2587	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: CEPHALEXIN

Reported adverse events (FAERS/openFDA)#

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