Cephalexin

Product NDC: 53002-2182
Requested package NDC: 53002-2182-4
11-digit product format: 530022182
Labeler code: 53002
Product ID: 53002-2182_89e7e532-d203-4675-a73d-38369e73e9d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA090836
Marketing category: ANDA
Marketing start: 2011-01-19
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: 2021-12-31
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	53002-2182	53002-2182-4	I	Inactivated by FDA		2026-08-03

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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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

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 · 164 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
2026-02-19 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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090836-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090836-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090836-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090836-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090836-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090836-001	AB	1	`8072bd15b7f6…`

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
53002-2182-1	2025-01-30	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
53002-2182-2	2025-01-30	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
53002-2182-3	2025-01-30	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
53002-2182-4	2025-01-30	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
53002-2182-5	2025-01-30	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
53002-2182-6	2025-01-30	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
53002-2182-9	2025-01-30	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
53002-2182-1	2023-06-07	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
53002-2182-2	2023-06-07	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
53002-2182-3	2023-06-07	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
53002-2182-4	2023-06-07	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
53002-2182-5	2023-06-07	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
53002-2182-6	2023-06-07	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
53002-2182-9	2023-06-07	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
53002-2182-1	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
53002-2182-2	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
53002-2182-3	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
53002-2182-4	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
53002-2182-5	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
53002-2182-6	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
53002-2182-9	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
53002-2182-1	2020-12-15	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
53002-2182-2	2020-12-15	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
53002-2182-3	2020-12-15	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
53002-2182-4	2020-12-15	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
53002-2182-5	2020-12-15	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
53002-2182-6	2020-12-15	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
53002-2182-9	2020-12-15	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
53002-2182-1	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
53002-2182-2	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
53002-2182-3	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
53002-2182-4	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
53002-2182-5	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
53002-2182-6	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
53002-2182-9	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	SPL version
53002-2182-1	Cephalexin	100 in 1 BOTTLE	CAPSULE	100	5
53002-2182-2	Cephalexin	100 in 1 BOTTLE	CAPSULE	100	5
53002-2182-3	Cephalexin	100 in 1 BOTTLE	CAPSULE	100	5
53002-2182-4	Cephalexin	100 in 1 BOTTLE	CAPSULE	100	5
53002-2182-5	Cephalexin	100 in 1 BOTTLE	CAPSULE	100	5
53002-2182-6	Cephalexin	100 in 1 BOTTLE	CAPSULE	100	5
53002-2182-9	Cephalexin	100 in 1 BOTTLE	CAPSULE	100	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2182	CEPHALEXIN CAPSULE [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 7 package rows	20230609_ee96b574-39d4-4001-928f-733d4f6d4dc6.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 1 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	a6b5edf2-1ef8-46b7-977a-8c303900f3f0	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	0384c418-b4d4-4c06-9ed9-13e864b1980b	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	d6954168-9c7f-4a6c-9262-2e6bed5c9f24	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	7508351d-69fe-457c-b450-9a2343be2587	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	980b9dd9-cb61-4c4f-81ac-85ee5a7c2497	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	759c3856-8d3a-4036-926c-8508b573c736	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	5b9b212a-3a3e-4637-b23c-6d66d8cf1171	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	11cfefee-d75e-430c-8817-02dc57de0e88	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	43ca66ae-2ada-412d-bc5d-f53602f535a5	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	cf1c5d03-eddc-463a-84ad-4d59362c2cf8	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	HAWAII REPACK, INC.	d54abc0a-3c8f-4f02-bd55-406f0c5b925a	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Northwind Health Company, LLC	4ecf9314-76e2-c270-e063-6294a90ad8db	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	e54df878-c235-4aa3-af33-fe5287c73138	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
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	REMEDYREPACK INC.	c600a2c0-42ab-4be8-b9b1-59ba39494b3f	2026-05-13	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	PD-Rx Pharmaceuticals, Inc.	a24a3c7c-c0f8-4107-ab30-751bea743d2d	2026-03-18	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

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	ee96b574-39d4-4001-928f-733d4f6d4dc6	5
309114	cephalexin 500 MG Oral Capsule	SCD	ee96b574-39d4-4001-928f-733d4f6d4dc6	5
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	ee96b574-39d4-4001-928f-733d4f6d4dc6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2182-4	53002218204	100 CAPSULE in 1 BOTTLE (53002-2182-4)	100 capsule	2018-10-01	0000-00-00	No	No	Current