Cephalexin

Product NDC: 68788-9539
11-digit product format: 687889539
Labeler code: 68788
Product ID: 68788-9539_8b197230-f3f8-48ac-9d94-b98a203dbd63
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA062703
Marketing category: ANDA
Marketing start: 2013-12-03
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: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-9539		D	Discontinued by firm	2026-08-17
excluded package	package	68788-9539	68788-9539-1	D	Discontinued by firm	2026-08-17
excluded package	package	68788-9539	68788-9539-2	D	Discontinued by firm	2026-08-17

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
A062703-001	CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13
A062703-002	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	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
A062703-001	AB
A062703-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062703-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		1987-02-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062703-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RS	1987-02-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A062703-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062703-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062703-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062703-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062703-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062703-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062703-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062703-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062703-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062703-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062703-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062703-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062703-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062703-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062703-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062703-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062703-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062703-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062703-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062703-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062703-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062703-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062703-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062703-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062703-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062703-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062703-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062703-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062703-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062703-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062703-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062703-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062703-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062703-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062703-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062703-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062703-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062703-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062703-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062703-002	AB	1	`bb7c543d1eb4…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	1
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CEPHALEXIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEPHALEXIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	CEPHALEXIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEPHALEXIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEPHALEXIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEPHALEXIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEPHALEXIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-9539	CEPHALEXIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	10	Legacy NDC	20250223_07631a8b-eb84-46aa-844e-e93e548cb9b2.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	549bf887-1ef6-6a75-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062703 application number: ANDA062703
Cephalexin	CEPHALEXIN	Proficient Rx LP	febab51b-6b48-488a-8fd1-d24400e5df1d	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062703 application number: ANDA062703
Cephalexin	CEPHALEXIN	Teva Pharmaceuticals USA, Inc.	19307ff0-71de-477b-965d-ea243e5ede3a	2020-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062703 application number: ANDA062703

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
68788-9539-1	68788953901	100 mL in 1 BOTTLE (68788-9539-1)	100 ml	2013-12-03	0000-00-00	No	No	Current
68788-9539-2	68788953902	200 mL in 1 BOTTLE (68788-9539-2)	200 ml	2013-12-03	0000-00-00	No	No	Current