Cephalexin

Product NDC: 80425-0004
Requested package NDC: 80425-0004-3
11-digit product format: 804250004
Labeler code: 80425
Product ID: 80425-0004_137a5de3-ab83-e2ab-e063-6294a90a6209
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: ADVANCED RX PHARMACY OF TENNESSEE, LLC
Application: ANDA065253
Marketing category: ANDA
Marketing start: 2022-09-14
Substance: CEPHALEXIN
Active strength: 500 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 1.

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 · 100 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 100 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065253-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065253-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065253-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065253-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065253-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065253-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

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
af49507d-254f-296d-e053-2a95a90ad263	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
80425-0004-1	Cephalexin	28 in 1 BOTTLE	CAPSULE	28	5
80425-0004-2	Cephalexin	40 in 1 BOTTLE	CAPSULE	40	5
80425-0004-3	Cephalexin	6 in 1 BOTTLE	CAPSULE	6	5
80425-0004-4	Cephalexin	5 in 1 BOTTLE	CAPSULE	5	5
80425-0004-5	Cephalexin	14 in 1 BOTTLE	CAPSULE	14	5
80425-0004-6	Cephalexin	20 in 1 BOTTLE	CAPSULE	20	5
80425-0004-7	Cephalexin	30 in 1 BOTTLE	CAPSULE	30	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0004-1	EA - Each	80425-0004	568b0d95-e053-4078-9588-aae633aac1c8	1	2023-03-13
80425-0004-2	EA - Each	80425-0004	08cd35d1-2cad-40a7-91fb-fdb8337d9e65	1	2023-03-13
80425-0004-3	EA - Each	80425-0004	fbaf8b0f-38f5-4531-9f5b-26ccf9d8e766	1	2024-06-10
80425-0004-4	EA - Each	80425-0004	49b4d903-13ce-40d3-89cf-31cd97d711e7	1	2024-04-05
80425-0004-5	EA - Each	80425-0004	1020912e-44d0-4ba7-bbbc-b3ce215a7748	1	2024-04-05
80425-0004-6	EA - Each	80425-0004	88fa8483-8c3b-4c86-bbfe-68a6da75564f	1	2024-04-05
80425-0004-7	EA - Each	80425-0004	9246bd25-019c-471d-a5b0-e435a401b8e4	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0004	CEPHALEXIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	5	Current NDC, Legacy NDC, 7 package rows	20240314_af49507d-254f-296d-e053-2a95a90ad263.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	88426cb3-1c0c-439b-9f1a-aa169040c29f	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Northwind Health Company, LLC	1d0d50ba-8c2c-855c-e063-6394a90a5c7d	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	47b6bc70-e8cc-4837-a39a-6998ee4e37dc	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	8a938dd0-fca6-4f22-9fb0-632596603001	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	2506895d-f3e0-4be9-95cb-7a6fd44de46d	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	52d8a080-eafc-46fe-82d9-6b69c6a3a38a	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Chartwell RX, LLC	d315cce8-9784-419e-818b-16d68d1dbd6e	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	0b3da88f-f513-cdf0-e063-6394a90a7205	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	2070b988-f7fb-4e35-91e3-1b7df5e5326c	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	AMELLA PHARMA, LLC	602fae70-3b8a-4f09-8db1-41fef4a2ecd7	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	c0ca008e-0e28-412e-a58f-70f63817713b	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	f3b46058-3e53-413b-b9c9-7d49e50f861e	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	88a744d8-a95e-4c63-8b25-52f5039b6ba1	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	0aad51b4-86d5-e312-e063-6394a90a250d	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	50f0187b-09e7-4c11-970f-91cd1877fde1	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	905b3270-abbd-4d5c-b313-3d20eb4b4c57	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	f2e73727-2ab6-4418-9677-19ea1d140bbd	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Coupler, LLC	30b7071e-cef1-bd41-e063-6394a90ad48e	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals, Inc.	28da5822-fb0b-1306-e063-6394a90a6e4c	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	A-S Medication Solutions	02b5cd6f-3df8-43c1-879d-217fcf55231a	2025-02-11	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	af49507d-254f-296d-e053-2a95a90ad263	5
309114	cephalexin 500 MG Oral Capsule	SCD	af49507d-254f-296d-e053-2a95a90ad263	5
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	af49507d-254f-296d-e053-2a95a90ad263	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0004-3	80425000403	6 CAPSULE in 1 BOTTLE (80425-0004-3)	6 capsule	2024-01-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cephalexin 500mg Capsules	ADVANCED RX PHARMACY OF TENNESSEE, LLC	2024-03-12	HUMAN PRESCRIPTION DRUG LABEL	5