Cephalexin

Product NDC: 42291-007
11-digit product format: 422910007
Labeler code: 42291
Product ID: 42291-007_563f2702-2b5f-464a-9f1f-9d5a7ac00c2a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: AVKARE
Application: ANDA062702
Marketing category: ANDA
Marketing start: 2026-04-24
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062702-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		1987-02-13
A062702-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		1987-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A062702-001	AB
A062702-002	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 · 82 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	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A062702-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062702-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062702-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062702-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062702-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062702-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062702-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062702-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062702-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062702-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062702-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062702-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062702-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062702-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062702-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062702-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062702-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062702-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062702-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062702-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062702-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062702-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062702-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062702-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062702-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062702-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062702-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062702-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062702-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062702-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062702-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062702-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062702-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062702-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062702-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062702-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062702-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062702-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062702-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062702-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309112	Internal RxNorm lookup
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
74f83298-57f7-4166-8dd8-db3e556a68d8	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	Strength	SPL version
42291-007-50	Cephalexin	500 in 1 BOTTLE	CAPSULE	500		1

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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	b73593ce-0b1f-4371-bae1-140742de3b42	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	Unit Dose Solutions, Inc.	53704ffd-b4f6-8b61-e063-6394a90a01f9	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	ad676021-44f3-4a97-a3dc-28a62fe982bb	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	3fed2817-fc0d-43cd-9f02-948fbc76672c	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	AVKARE	74f83298-57f7-4166-8dd8-db3e556a68d8	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702 ndc (product): 42291-007
Cephalexin	CEPHALEXIN	QPharma Inc	e8b3ece4-cf73-416c-8767-68f425df35f8	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	QPharma Inc	4e9a8ed3-c490-4a0e-bb29-5eea506f893b	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	6ce11859-aa21-4b3f-bd59-3cd26deca82b	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	A-S Medication Solutions	bff3912c-c39c-40c0-98d2-27c3d506c24d	2025-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	ade02343-3e4b-b1f1-e053-2995a90ac5fe	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	A-S Medication Solutions	fc426d0d-9774-4189-8d83-89aa85d926bb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	A-S Medication Solutions	5b7666f3-4014-45ce-8387-3298d9fe6d25	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	18518154-30ba-48a4-852a-3a7723030071	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	Proficient Rx LP	ada7b8a5-98f4-454c-b38f-92192d4db33f	2021-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	Teva Pharmaceuticals USA, Inc.	19307ff0-71de-477b-965d-ea243e5ede3a	2020-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702

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	74f83298-57f7-4166-8dd8-db3e556a68d8	1
309114	cephalexin 500 MG Oral Capsule	PSN	74f83298-57f7-4166-8dd8-db3e556a68d8	1
309112	cephalexin 250 MG Oral Capsule	SCD	74f83298-57f7-4166-8dd8-db3e556a68d8	1
309114	cephalexin 500 MG Oral Capsule	SCD	74f83298-57f7-4166-8dd8-db3e556a68d8	1
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	74f83298-57f7-4166-8dd8-db3e556a68d8	1
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	74f83298-57f7-4166-8dd8-db3e556a68d8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-007-50	42291000750	500 CAPSULE in 1 BOTTLE (42291-007-50)	500 capsule	2026-04-24	No	No	Current