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004	KEFLEX	CEPHALEXIN	CAPSULE;ORAL	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N050405-002	KEFLEX	CEPHALEXIN	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N050405-003	KEFLEX	CEPHALEXIN	EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N050405-004	KEFLEX	CEPHALEXIN	EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12
N050405-005	KEFLEX	CEPHALEXIN	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2006-05-12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N050405-002	KEFLEX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`84e616aacf4f…`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 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.

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