Cephalexin

Product NDC: 68071-4406
Requested package NDC: 68071-4406-4
11-digit product format: 680714406
Labeler code: 68071
Product ID: 68071-4406_1a8b85ac-ef99-e207-e063-6394a90a80f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA065229
Marketing category: ANDA
Marketing start: 2006-01-11
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065229-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2005-11-25
A065229-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2005-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065229-001	AB
A065229-002	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	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`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	A065229-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065229-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065229-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065229-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065229-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065229-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065229-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065229-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065229-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065229-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065229-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065229-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065229-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065229-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065229-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065229-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065229-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065229-002	AB	1	`782e0a99824c…`

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
6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-4406-4	2021-02-16	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
68071-4406-7	2021-02-16	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
68071-4406-4	2021-01-29	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
68071-4406-7	2021-01-29	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, 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
68071-4406-4	Cephalexin	14 in 1 BOTTLE	CAPSULE	14		4
68071-4406-7	Cephalexin	40 in 1 BOTTLE	CAPSULE	40		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4406	CEPHALEXIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240612_6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e.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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	b3bb8222-161e-4d9c-8e08-7e22ad65bf72	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	8499aa5a-49b1-4555-bd27-6177d92b261d	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Coupler LLC	508a3401-df0b-0555-e063-6294a90a155a	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Sportpharm LLC	3d5a2665-65da-4b10-9e23-39fc88145da1	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	13444dc7-7da1-4181-a9ac-d95d4a235e6d	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Lupin Pharmaceuticals, Inc.	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af4abf8b-22cc-da58-e053-2a95a90aa766	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	a33280d4-7caf-f74b-e053-2a95a90a90c3	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc	945552cb-90e4-41fb-afe2-8ee8785e94da	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	20f8cc57-231c-4d36-a209-ff9e5735d65c	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229 ndc (package): 68071-4406-4 ndc (product): 68071-4406 ndc11 (package): 68071440604
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	728c5212-dbd8-8df5-e053-2a91aa0a9579	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af10128f-021a-14b7-e053-2a95a90a4365	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	6032b68f-16d8-41b6-bd2c-86d5406a757a	2022-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Proficient Rx LP	dec3a1ef-1e85-4236-804b-e7a343d3a58f	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229

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	6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e	4
309114	cephalexin 500 MG Oral Capsule	SCD	6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e	4
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4406-4	68071440604	14 CAPSULE in 1 BOTTLE (68071-4406-4)	14 capsule	2018-04-26	0000-00-00	No	No	Current