Cephalexin

Product NDC: 10544-025
11-digit product format: 105440025
Labeler code: 10544
Product ID: 10544-025_bb6ce0ee-0d20-43d0-b3b7-78518fec1cf3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA065152
Marketing category: ANDA
Marketing start: 2010-11-05
Marketing end: 0000-00-00
Substance: CEPHALEXIN
Active strength: 500 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10544-025		I	Inactivated by FDA	2026-10-15
excluded package	package	10544-025	10544-025-10	I	Inactivated by FDA	2026-10-15
excluded package	package	10544-025	10544-025-14	I	Inactivated by FDA	2026-10-15
excluded package	package	10544-025	10544-025-20	I	Inactivated by FDA	2026-10-15
excluded package	package	10544-025	10544-025-28	I	Inactivated by FDA	2026-10-15
excluded package	package	10544-025	10544-025-30	I	Inactivated by FDA	2026-10-15
excluded package	package	10544-025	10544-025-40	I	Inactivated by FDA	2026-10-15

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 3 · 154 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	10544-025-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-025-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-025-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-025-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-025-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10544-025-20	`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	10544-025-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-025-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-025-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-025-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-025-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10544-025-20	`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	10544-025-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-025-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-025-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-025-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-025-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10544-025-20	`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	10544-025-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-025-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-025-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-025-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-025-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10544-025-20	`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	10544-025-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-025-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-025-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-025-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-025-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10544-025-20	`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	10544-025-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-025-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-025-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-025-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-025-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10544-025-20	`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	10544-025-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-025-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-025-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-025-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-025-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10544-025-20	`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	10544-025-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-025-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-025-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-025-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-025-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10544-025-20	`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	10544-025-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-025-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10544-025-40	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065152-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065152-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-02-24	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	A065152-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065152-002	AB	1	`782e0a99824c…`
2021-03-12 10:30 UTC	2021-03	A065152-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065152-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065152-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065152-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065152-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065152-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065152-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065152-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065152-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065152-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065152-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065152-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065152-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065152-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065152-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A065152-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065152-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065152-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065152-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065152-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065152-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065152-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065152-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065152-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065152-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065152-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065152-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065152-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065152-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065152-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065152-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065152-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065152-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065152-002	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
10544-025-10	CEPHALEXIN CAPSULES, USP
10544-025-14	CEPHALEXIN CAPSULES, USP
10544-025-20	CEPHALEXIN CAPSULES, USP
10544-025-28	CEPHALEXIN CAPSULES, USP
10544-025-30	CEPHALEXIN CAPSULES, USP
10544-025-40	CEPHALEXIN CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10544-025-10	Cephalexin	10 in 1 BOTTLE	CAPSULE	10	1
10544-025-14	Cephalexin	14 in 1 BOTTLE	CAPSULE	14	1
10544-025-20	Cephalexin	20 in 1 BOTTLE	CAPSULE	20	1
10544-025-28	Cephalexin	28 in 1 BOTTLE	CAPSULE	28	1
10544-025-30	Cephalexin	30 in 1 BOTTLE	CAPSULE	30	1
10544-025-40	Cephalexin	40 in 1 BOTTLE	CAPSULE	40	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-025-10	EA - Each	10544-025	0d2161ae-a6c8-4e49-a2ad-cb2024ad4d5f	1	2015-10-02
10544-025-14	EA - Each	10544-025	af8dcbd2-44c8-4e68-80c0-e7250a57ece1	1	2015-10-02
10544-025-28	EA - Each	10544-025	b1adb3e8-be80-4dd0-9e73-4e3aedd60577	1	2015-10-02
10544-025-30	EA - Each	10544-025	fcb211cb-7042-46ff-a1cc-0c1a2cf3724b	1	2015-10-02
10544-025-40	EA - Each	10544-025	e0cef7cb-0edf-49b3-8ace-eb19883a84f4	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Cephalexin	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Cephalexin Anhydrous	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Ammonia	INACTIVE INGREDIENT	5138Q19F1X	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Butyl Alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Colloidal Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FD&C Yellow No. 5	INACTIVE INGREDIENT	I753WB2F1M	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Potassium Hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Shellac	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-025	CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 6 package rows	20130525_5399cebf-caf8-40f8-a1fa-a2e547a2b817.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309114	cephalexin 500 MG Oral Capsule	PSN	5399cebf-caf8-40f8-a1fa-a2e547a2b817	1
309114	cephalexin 500 MG Oral Capsule	SCD	5399cebf-caf8-40f8-a1fa-a2e547a2b817	1
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	5399cebf-caf8-40f8-a1fa-a2e547a2b817	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-025-10	10544002510	10 in 1 BOTTLE	Historical
10544-025-14	10544002514	14 in 1 BOTTLE	Historical
10544-025-20	10544002520	20 in 1 BOTTLE	Historical
10544-025-28	10544002528	28 in 1 BOTTLE	Historical
10544-025-30	10544002530	30 in 1 BOTTLE	Historical
10544-025-40	10544002540	40 in 1 BOTTLE	Historical