Cephalexin

Product NDC: 51655-028
Requested package NDC: 51655-028-52
11-digit product format: 516550028
Labeler code: 51655
Product ID: 51655-028_d4792380-58e4-48b6-e053-2a95a90adf5a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: Northwind Pharmaceuticals, LLC
Application: ANDA090836
Marketing category: ANDA
Marketing start: 2014-11-06
Marketing end: 0000-00-00
Substance: CEPHALEXIN
Active strength: 500 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	51655-028	51655-028-52	D	Discontinued by firm		2026-10-15

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 · 16 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 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	A090836-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090836-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090836-004	AB	1	`c2088c7a36db…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
51655-028-20	2026-01-02	These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
51655-028-52	2026-01-02	These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
51655-028-20	2023-01-30	These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
51655-028-52	2023-01-30	These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
51655-028-20	2020-07-01	These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
51655-028-52	2020-07-01	These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
51655-028-20	2020-01-31	These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971
51655-028-52	2020-01-31	These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51655-028-20	Cephalexin	20 in 1 BOTTLE, DISPENSING	CAPSULE	20		4
51655-028-52	Cephalexin	30 in 1 BOTTLE, DISPENSING	CAPSULE	30		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-028	CEPHALEXIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	3	Legacy NDC, 2 package rows	20220101_89bb3920-69bf-4818-b573-4bd845f6e2d5.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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Ascend Laboratories, LLC	4fec8daf-6e09-4153-926f-64709dbdd26c	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Proficient Rx LP	7059a0b2-dd57-4fc1-ac3d-6aead35a4b08	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
CEPHALEXIN	CEPHALEXIN	Direct_Rx	90051655-77e9-6753-e053-2a95a90a462c	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Sportpharm LLC	da97ca40-3b22-432b-a3e9-0902dbef06a9	2026-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
CEPHALEXIN	CEPHALEXIN	Direct_Rx	90148caf-4291-da8b-e053-2a95a90a9bd3	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Sportpharm LLC	75820198-5efe-4ba0-ad50-e88d22fe075e	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	QPharma Inc	a9d2e29e-9c3f-429d-9d22-481807becd33	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	QPharma Inc	c0e0533c-da78-7109-e053-2a95a90a4f5c	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	11efa03d-0da9-419a-b53d-65a5671dccb0	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	AvPAK	5975f293-8bb3-3242-aca7-d7d0c7e1bdc8	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	A-S Medication Solutions	21392758-c033-4d4d-81c9-d10e132f95b7	2025-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	American Health Packaging	cb64cab2-5297-4ed2-a50a-2e5d5e14fa8d	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Chartwell RX, LLC.	3c459965-2d42-488b-80c4-ce801f94839c	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	fe6fff2f-f95c-4057-a71b-7ef6c5d415cc	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	31afe835-8ec8-4ac0-8a2a-c3e9283fa6ea	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	8a691ff2-eb16-4357-87ee-0ac9c99a5cb7	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	9694f7a6-bcec-4809-b261-cdd3740968cb	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	6e5f9616-ddf2-19c4-e053-2991aa0a372a	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	A-S Medication Solutions	3fcb3f88-9dfc-444d-952a-1d1967720525	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	4eb58a7e-1c92-4be3-b702-e522e0fbf425	2024-06-21	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
309114	cephalexin 500 MG Oral Capsule	PSN	89bb3920-69bf-4818-b573-4bd845f6e2d5	4
309114	cephalexin 500 MG Oral Capsule	SCD	89bb3920-69bf-4818-b573-4bd845f6e2d5	4
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	89bb3920-69bf-4818-b573-4bd845f6e2d5	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51655-028-52	51655002852	30 CAPSULE in 1 BOTTLE, DISPENSING (51655-028-52)	30 capsule	2014-11-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cephalexin	Northwind Pharmaceuticals, LLC \| EPM Packaging	2026-01-02	HUMAN PRESCRIPTION DRUG LABEL	4