Cephalexin

Product NDC: 63629-1317
Requested package NDC: 63629-1317-5
11-digit product format: 636291317
Labeler code: 63629
Product ID: 63629-1317_a8352374-abdb-493f-9aaf-6196f6827427
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA065229
Marketing category: ANDA
Marketing start: 2006-01-11
Marketing end: 0000-00-00
Substance: CEPHALEXIN
Active strength: 250 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-1317	63629-1317-5	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065229-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2005-11-25
A065229-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2005-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065229-001	AB
A065229-002	AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065229-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065229-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065229-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065229-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065229-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065229-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065229-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065229-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065229-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065229-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065229-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065229-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065229-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065229-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065229-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065229-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065229-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065229-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1317-1	EA - Each	63629-1317	06dfe02f-2fbf-48b4-8a12-72a4e8229bfb	1	2017-06-15
63629-1317-2	EA - Each	63629-1317	b1ba9f88-4e41-4ace-83bb-583edfe9997d	1	2017-06-15
63629-1317-3	EA - Each	63629-1317	dca84c92-ed34-427c-b322-097930141583	1	2017-06-15
63629-1317-4	EA - Each	63629-1317	fbf2ebca-851f-4f13-89a6-fe343b0c8869	1	2017-06-15
63629-1317-5	EA - Each	63629-1317	d0d91497-fc12-457f-93a5-45c7e02f364c	1	2017-06-15

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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	b3bb8222-161e-4d9c-8e08-7e22ad65bf72	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	8499aa5a-49b1-4555-bd27-6177d92b261d	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Coupler LLC	508a3401-df0b-0555-e063-6294a90a155a	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Sportpharm LLC	3d5a2665-65da-4b10-9e23-39fc88145da1	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	13444dc7-7da1-4181-a9ac-d95d4a235e6d	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Lupin Pharmaceuticals, Inc.	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af4abf8b-22cc-da58-e053-2a95a90aa766	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	a33280d4-7caf-f74b-e053-2a95a90a90c3	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc	945552cb-90e4-41fb-afe2-8ee8785e94da	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	20f8cc57-231c-4d36-a209-ff9e5735d65c	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	728c5212-dbd8-8df5-e053-2a91aa0a9579	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af10128f-021a-14b7-e053-2a95a90a4365	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	6032b68f-16d8-41b6-bd2c-86d5406a757a	2022-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Proficient Rx LP	dec3a1ef-1e85-4236-804b-e7a343d3a58f	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OBN7UDS42Y	CEPHALEXIN	23325-78-2	CEPHALEXIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1317-5	63629131705	100 CAPSULE in 1 BOTTLE (63629-1317-5)	100 capsule	2006-01-11	0000-00-00	No	No	Current