CEPHALEXIN

Product NDC: 61919-049
11-digit product format: 619190049
Labeler code: 61919
Product ID: 61919-049_9c5b1895-9488-84b7-e053-2995a90a9940
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEPHALEXIN
Dosage form: FOR SUSPENSION
Route: ORAL
Labeler: DIRECT RX
Application: ANDA065234
Marketing category: ANDA
Marketing start: 2014-01-01
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: 2021-12-31
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	61919-049		I	Inactivated by FDA		2026-08-17
excluded package	package	61919-049	61919-049-32	I	Inactivated by FDA		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 · 32 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-049-32	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-049-32	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-049-32	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-049-32	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-049-32	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-049-32	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-049-32	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-049-32	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-049-32	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-049-32	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-049-32	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-049-32	I	Inactivated by FDA	`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	61919-049-32	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	61919-049-32	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	61919-049-32	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-049-32	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A065234-001	CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2005-08-17
A065234-002	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2005-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065234-001	AB
A065234-002	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	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065234-001	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065234-002	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2005-08-17	`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	A065234-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065234-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065234-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065234-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065234-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065234-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065234-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065234-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065234-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065234-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065234-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065234-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065234-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065234-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065234-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065234-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065234-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065234-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065234-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065234-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065234-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065234-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065234-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065234-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065234-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065234-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065234-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065234-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065234-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dfa3f520-409c-432e-b6d3-9250d468c772	Product name	1	20250401
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
64bb7f1a-2c2e-4741-8301-dbfeda7239f6	Product name	1	20190628
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
398aa563-bb78-fe0f-46a8-757c40ef28bf	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-049-32	2023-01-30	C162847	48780-1	f386c649-e32c-0266-e053-dadaa90a7c1a	CEPHALEXIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-049-32	CEPHALEXIN	5 mL in 1 BOTTLE	FOR SUSPENSION	5		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-049-32	ML - Milliliter	61919-049	fdc63d91-84cd-4d8e-b423-0b76bb162904	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN SUSPENSION [DIRECT RX]	1
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN SUSPENSION [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEPHALEXIN SUSPENSION [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEPHALEXIN SUSPENSION [DIRECT RX]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEPHALEXIN SUSPENSION [DIRECT RX]	1
STRAWBERRY	INACTIVE INGREDIENT	4J2TY8Y81V	CEPHALEXIN SUSPENSION [DIRECT RX]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEPHALEXIN SUSPENSION [DIRECT RX]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEPHALEXIN SUSPENSION [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-049	CEPHALEXIN FOR SUSPENSION [DIRECT RX]	3	Legacy NDC, 1 package rows	20200130_2b9516da-d99b-4d12-b45b-01c03576f3f0.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cephalexin	CEPHALEXIN	Lupin Pharmaceuticals, Inc.	25ef498a-7a7e-4543-a544-b9d0e99f9cd9	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	553485f8-890d-4929-a6bb-905221cf411d	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	141bd050-5dfc-68fa-e063-6394a90a6d86	2024-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	A-S Medication Solutions	d31da5be-c939-4aa0-adb8-b26a1396b228	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	Proficient Rx LP	829244bd-93da-4a5a-a257-890cfec4c06d	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234
cephalexin	CEPHALEXIN	A-S Medication Solutions	0a24b6e5-6f13-44b4-93f4-47c86945cad2	2023-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065234 application number: ANDA065234

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
309113	cephalexin 250 MG in 5 mL Oral Suspension	PSN	2b9516da-d99b-4d12-b45b-01c03576f3f0	3
309113	cephalexin 50 MG/ML Oral Suspension	SCD	2b9516da-d99b-4d12-b45b-01c03576f3f0	3
309113	cefalexin 50 MG/ML Oral Suspension	SY	2b9516da-d99b-4d12-b45b-01c03576f3f0	3
309113	cephalexin 250 MG per 5 ML Oral Suspension	SY	2b9516da-d99b-4d12-b45b-01c03576f3f0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-049-32	61919004932	5 mL in 1 BOTTLE (61919-049-32)	5 ml	2015-01-01	0000-00-00	No	No	Current