Cephalexin

Product NDC: 68788-8538
11-digit product format: 687888538
Labeler code: 68788
Product ID: 68788-8538_cabeccb5-a7a9-4906-90f5-70af57054fa6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA065253
Marketing category: ANDA
Marketing start: 2023-10-19
Substance: CEPHALEXIN
Active strength: 500 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	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 · 109 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
2026-10-15 13:18:30	2026-09	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 109 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A065253-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065253-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065253-003	AB	1	`c2088c7a36db…`
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…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEPHALEXIN	500 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
309114	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
52d8a080-eafc-46fe-82d9-6b69c6a3a38a	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	SPL version
68788-8538-1	Cephalexin	12 in 1 BOTTLE	CAPSULE	12	4
68788-8538-2	Cephalexin	20 in 1 BOTTLE	CAPSULE	20	4
68788-8538-3	Cephalexin	30 in 1 BOTTLE	CAPSULE	30	4
68788-8538-4	Cephalexin	40 in 1 BOTTLE	CAPSULE	40	4
68788-8538-5	Cephalexin	6 in 1 BOTTLE	CAPSULE	6	4
68788-8538-6	Cephalexin	60 in 1 BOTTLE	CAPSULE	60	4
68788-8538-7	Cephalexin	21 in 1 BOTTLE	CAPSULE	21	4
68788-8538-8	Cephalexin	28 in 1 BOTTLE	CAPSULE	28	4
68788-8538-9	Cephalexin	14 in 1 BOTTLE	CAPSULE	14	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8538-1	EA - Each	68788-8538	1237de30-3f7e-4214-830e-175bc15e0d25	1	2023-12-05
68788-8538-2	EA - Each	68788-8538	112e5e0b-82e3-41b5-833e-ae78f96125db	1	2023-12-05
68788-8538-3	EA - Each	68788-8538	1b0dfb80-0b41-420e-8747-8374e1f70c9b	1	2023-12-05
68788-8538-4	EA - Each	68788-8538	e830649f-f0e6-478d-b058-e7314d1fc38e	1	2023-12-05
68788-8538-5	EA - Each	68788-8538	1cdbf78c-e01e-4868-9862-55332a810a4e	1	2023-12-05
68788-8538-6	EA - Each	68788-8538	2b3074c7-6e62-4429-90fe-ba4cb5d4b6a1	1	2023-12-05
68788-8538-7	EA - Each	68788-8538	9b31f3aa-1ae9-4f9c-ab86-b99d79c813be	1	2023-12-05
68788-8538-8	EA - Each	68788-8538	3edc8af2-02d9-487b-8484-af65db1a77dd	1	2023-12-05
68788-8538-9	EA - Each	68788-8538	f172f694-2eb2-47fd-b8b8-5263da56b14c	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8538	CEPHALEXIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, 9 package rows	20250223_52d8a080-eafc-46fe-82d9-6b69c6a3a38a.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 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	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

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
309114	cephalexin 500 MG Oral Capsule	PSN	52d8a080-eafc-46fe-82d9-6b69c6a3a38a	4
309114	cephalexin 500 MG Oral Capsule	SCD	52d8a080-eafc-46fe-82d9-6b69c6a3a38a	4
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	52d8a080-eafc-46fe-82d9-6b69c6a3a38a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8538-1	68788853801	12 CAPSULE in 1 BOTTLE (68788-8538-1)	12 capsule	2023-10-19	No	No	Current
68788-8538-2	68788853802	20 CAPSULE in 1 BOTTLE (68788-8538-2)	20 capsule	2023-10-19	No	No	Current
68788-8538-3	68788853803	30 CAPSULE in 1 BOTTLE (68788-8538-3)	30 capsule	2023-10-19	No	No	Current
68788-8538-4	68788853804	40 CAPSULE in 1 BOTTLE (68788-8538-4)	40 capsule	2023-10-19	No	No	Current
68788-8538-5	68788853805	6 CAPSULE in 1 BOTTLE (68788-8538-5)	6 capsule	2023-10-19	No	No	Current
68788-8538-6	68788853806	60 CAPSULE in 1 BOTTLE (68788-8538-6)	60 capsule	2023-10-19	No	No	Current
68788-8538-7	68788853807	21 CAPSULE in 1 BOTTLE (68788-8538-7)	21 capsule	2023-10-19	No	No	Current
68788-8538-8	68788853808	28 CAPSULE in 1 BOTTLE (68788-8538-8)	28 capsule	2023-10-19	No	No	Current
68788-8538-9	68788853809	14 CAPSULE in 1 BOTTLE (68788-8538-9)	14 capsule	2023-10-19	No	No	Current