Cephalexin

Product NDC: 68071-5016
11-digit product format: 680715016
Labeler code: 68071
Product ID: 68071-5016_bbb33bb3-3408-ff00-e053-2a95a90ad228
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA065152
Marketing category: ANDA
Marketing start: 2018-02-28
Marketing end: 0000-00-00
Substance: CEPHALEXIN
Active strength: 250 mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-5016		D	Discontinued by firm		2026-08-17
excluded package	package	68071-5016	68071-5016-0	D	Discontinued by firm		2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-5016-0	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-5016-0	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-5016-0	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-5016-0	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-5016-0	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-5016-0	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-5016-0	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-5016-0	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-5016-0	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-5016-0	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-5016-0	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-5016-0	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-5016-0	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-5016-0	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-5016-0	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065152-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2005-02-24
A065152-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2005-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065152-001	AB
A065152-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`bb7c543d1eb4…`

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
2026-08-18 06:07:40	2026-07	A065152-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065152-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065152-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065152-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065152-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065152-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065152-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065152-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065152-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065152-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065152-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065152-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065152-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065152-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065152-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065152-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065152-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065152-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065152-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065152-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065152-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065152-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065152-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065152-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065152-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065152-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065152-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065152-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065152-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065152-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065152-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065152-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065152-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065152-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065152-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065152-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065152-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065152-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065152-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065152-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-19	These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN for oral suspension USP, for oral use Initial U.S. Approval: 1971
2023-01-30	These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN for oral suspension USP, for oral use Initial U.S. Approval: 1971
2021-02-19	These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN for oral suspension USP, for oral use Initial U.S. Approval: 1971
2021-01-29	These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN for oral suspension USP, for oral use Initial U.S. Approval: 1971

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Pharma-C, Inc.	bf9a6c06-11fd-4fb7-9cf5-e8e787758c1c	2016-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065152 application number: ANDA065152

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OBN7UDS42Y	CEPHALEXIN	23325-78-2	CEPHALEXIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5016-0	68071501600	100 mL in 1 BOTTLE (68071-5016-0)	100 ml	2019-08-06	0000-00-00	No	No	Current