Cephalexin

Product NDC: 0143-9770
11-digit product format: 001439770
Labeler code: 0143
Product ID: 0143-9770_f89a6534-c8eb-48b2-b702-7b2edcb0aa1a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA065444
Marketing category: ANDA
Marketing start: 2009-09-01
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0143-9770		D	Discontinued by firm	2026-08-03
excluded package	package	0143-9770	0143-9770-01	D	Discontinued by firm	2026-08-03
excluded package	package	0143-9770	0143-9770-24	D	Discontinued by firm	2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-9770-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-9770-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-9770-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-9770-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-9770-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-9770-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-9770-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-9770-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-9770-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-9770-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-9770-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-9770-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-9770-24	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-9770-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-9770-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-9770-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-9770-24	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-9770-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-9770-24	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-9770-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-9770-24	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-9770-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-9770-24	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-9770-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A065444-001	CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL			2009-08-28
A065444-002	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL			2009-08-28

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065444-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065444-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	2009-08-28	`782e0a99824c…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
CITRIC ACID	INACTIVE INGREDIENT	2968PHW8QP	CEPHALEXIN SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEPHALEXIN SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CEPHALEXIN SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEPHALEXIN SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEPHALEXIN SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	5

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
0143-9770-01	00143977001	100 mL in 1 BOTTLE (0143-9770-01)	100 ml	2009-09-01	0000-00-00	No	No	Current
0143-9770-24	00143977024	200 mL in 1 BOTTLE (0143-9770-24)	200 ml	2009-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cephalexin	Hikma Pharmaceuticals USA Inc. \| Al Jazeera for Pharmaceuticals Industries	2019-07-31	HUMAN PRESCRIPTION DRUG LABEL	8