Cephalexin

Product NDC: 72789-252
11-digit product format: 727890252
Labeler code: 72789
Product ID: 72789-252_5b75a687-9985-e0fe-e063-6394a90ac713
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA090836
Marketing category: ANDA
Marketing start: 2011-01-20
Substance: CEPHALEXIN
Active strength: 250 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 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	TE codes	RLD / RS	Approval date
A090836-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20
A090836-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20
A090836-003	CEPHALEXIN	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29
A090836-004	CEPHALEXIN	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090836-001	AB
A090836-002	AB
A090836-004	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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A090836-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090836-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090836-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090836-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090836-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090836-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090836-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090836-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090836-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090836-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090836-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090836-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090836-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090836-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090836-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090836-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090836-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090836-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090836-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090836-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090836-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090836-001	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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEPHALEXIN	250 mg/1

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
72789-252-01	Cephalexin	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-252-01	EA - Each	72789-252	9294f1c9-1857-49fe-a8e0-f2114459c54c	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-252	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	31	Current NDC, Legacy NDC, 1 package rows	20241011_1716ea1e-40a9-4a23-870b-3c7e3d070095.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 3 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	681c235f-6dee-1401-e053-2991aa0addc0	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	A-S Medication Solutions	73920373-b45d-45d6-b183-d962467dde36	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	A-S Medication Solutions	712a6789-7aab-4114-ae92-d1c7686c6b96	2024-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	4fccce5a-4e39-46cd-976a-32ff71189520	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	f501f3a9-48e9-451a-a4b6-46d268b7bd3d	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	8d25d863-9ec2-4b76-b2e5-d4e2e39639a5	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Advanced Rx Pharmacy of Tennessee, LLC	b6ffe633-dd91-6d49-e053-2a95a90a5ac6	2024-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	9a1f2ab7-d8af-444f-96c2-56b666d4c79a	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	ea10d05a-2e39-4a30-8935-5555bc1e515e	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	A-S Medication Solutions	ab3fc544-3652-4de5-a7ff-e013adb69b5a	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	A-S Medication Solutions	ee0603a5-0758-4968-89e3-1aa95e9967f2	2023-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	A-S Medication Solutions	7cbdfa7f-2ea0-48e1-b506-59f58e5685a6	2023-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Major Pharmaceuticals	1c1fbad7-bef4-42a0-a8c9-b35168f5d533	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	2cb7bc3a-988b-4414-8036-fb09b2ab5767	2023-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	b270d537-878b-4468-b246-b704adb29ced	2023-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	8073f183-e11f-41af-8bd1-1505bc7e044b	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
CEPHALEXIN	CEPHALEXIN	DIRECT RX	2d12e6a9-f7dd-25ed-e054-00144ff8d46c	2022-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	891b8c0e-dbf4-4b0e-ba3f-c4c49d51510d	2022-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836

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	1716ea1e-40a9-4a23-870b-3c7e3d070095	32
309112	cephalexin 250 MG Oral Capsule	SCD	1716ea1e-40a9-4a23-870b-3c7e3d070095	32
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	1716ea1e-40a9-4a23-870b-3c7e3d070095	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-252-01	72789025201	100 CAPSULE in 1 BOTTLE, PLASTIC (72789-252-01)	100 capsule	2022-05-10	0000-00-00	No	No	Current