Cephalexin

Product NDC: 62135-710
11-digit product format: 621350710
Labeler code: 62135
Product ID: 62135-710_459b593b-9fc1-fa2e-e063-6394a90a5092
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA065253
Marketing category: ANDA
Marketing start: 2005-11-16
Substance: CEPHALEXIN
Active strength: 250 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	TE codes	Approval date
A065253-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16
A065253-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16
A065253-003	CEPHALEXIN	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A065253-001	AB
A065253-002	AB
A065253-003	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 · 106 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
2026-09-14 22:38:34	2026-08	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065253-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065253-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065253-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Cephalexin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEPHALEXIN	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OBN7UDS42Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309112	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d315cce8-9784-419e-818b-16d68d1dbd6e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dfa3f520-409c-432e-b6d3-9250d468c772	Product name	1	20250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6	Product name	1	20190628
398aa563-bb78-fe0f-46a8-757c40ef28bf	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62135-710-74	Cephalexin	40 in 1 BOTTLE	CAPSULE	40		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-710-74	EA - Each	62135-710	529a5176-6ef7-47fc-8165-32cb3dbce99b	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-710	CEPHALEXIN CAPSULE [CHARTWELL RX, LLC]	2	Current NDC, 1 package rows	20241016_d315cce8-9784-419e-818b-16d68d1dbd6e.zip

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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	12f78d76-ea13-440c-8dd0-5aec86277acf	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Cronus Pharma LLC	a4e861e2-5803-4c4a-a962-92f5755e1ab5	2025-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	8e28f049-6110-4473-830f-c494191a7197	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	A-S Medication Solutions	99ef59d5-bc44-4727-86fe-dc81357207c3	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	A-S Medication Solutions	65b38519-1d8a-4aca-b415-c64cca84d085	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals, Inc.	216660f3-0329-ef7d-e063-6294a90a17df	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Proficient Rx LP	e43271ef-c145-4145-b7f0-a02c237de2b5	2024-08-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af49507d-254f-296d-e053-2a95a90ad263	2024-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	f957ea27-2906-40c7-ac03-eb2f742473a0	2023-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309112	cephalexin 250 MG Oral Capsule	PSN	d315cce8-9784-419e-818b-16d68d1dbd6e	3
309112	cephalexin 250 MG Oral Capsule	SCD	d315cce8-9784-419e-818b-16d68d1dbd6e	3
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	d315cce8-9784-419e-818b-16d68d1dbd6e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-710-74	62135071074	40 CAPSULE in 1 BOTTLE (62135-710-74)	40 capsule	2023-02-27	No	No	Current