Application 050405

Type: NDA
Sponsor: PRAGMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	KEFLEX	CEPHALEXIN	CAPSULE;ORAL	EQ 250MG BASE	Yes	No
003	KEFLEX	CEPHALEXIN	CAPSULE;ORAL	EQ 500MG BASE	Yes	No
004	KEFLEX	CEPHALEXIN	CAPSULE;ORAL	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	KEFLEX	CEPHALEXIN	CAPSULE;ORAL	EQ 750MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050405-002	KEFLEX	CEPHALEXIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N050405-003	KEFLEX	CEPHALEXIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N050405-004	KEFLEX	CEPHALEXIN	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12
N050405-005	KEFLEX	CEPHALEXIN	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12

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 5 · 172 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	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050405-003	KEFLEX	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050405-004	KEFLEX	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050405-005	KEFLEX	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050405-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050405-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050405-005	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050405-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050405-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050405-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050405-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050405-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050405-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050405-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050405-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050405-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050405-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050405-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050405-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050405-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050405-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050405-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050405-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050405-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050405-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050405-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050405-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050405-005	AB	1	`ea99ee380514…`

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48102-021	Cephalexin	CEPHALEXIN	Fera Pharmaceuticals, LLC	NDA	Current
48102-021	Cephalexin	CEPHALEXIN	Fera Pharmaceuticals, LLC	NDA	Current
48102-021	Cephalexin	CEPHALEXIN	Fera Pharmaceuticals, LLC	NDA	Current
58463-011	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, L	NDA	Current
58463-011	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-011	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-012	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, L	NDA	Current
58463-012	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-012	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-013	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, L	NDA	Current
58463-013	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-013	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
58463-013	KEFLEX	CEPHALEXIN	Pragma Pharmaceuticals, LLC	NDA	Current
59630-112	Keflex	cephalexin	Shionogi Inc.	NDA	Current
59630-113	Keflex	cephalexin	Shionogi Inc.	NDA	Current
59630-115	Keflex	cephalexin	Shionogi Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73638	SUPPL	2023-03-01
56961	SUPPL	2018-12-21
56959	SUPPL	2018-12-21
56903	SUPPL	2018-12-20
56901	SUPPL	2018-12-20
38930	SUPPL	2015-11-04
7732	SUPPL	2015-11-04
30012	SUPPL	2008-09-17
30011	SUPPL	2008-05-21
17820	SUPPL	2006-05-16
7731	SUPPL	2006-05-16
7730	SUPPL	2004-12-02
30010	SUPPL	2004-07-01
38929	SUPPL	2004-01-22
30009	SUPPL	2004-01-22