Cephalexin

Product NDC: 70934-065
11-digit product format: 709340065
Labeler code: 70934
Product ID: 70934-065_a12a960c-0d00-0caf-e053-2a95a90a6548
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA065229
Marketing category: ANDA
Marketing start: 2018-01-18
Marketing end: 0000-00-00
Substance: CEPHALEXIN
Active strength: 500 mg/1
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70934-065		I	Inactivated by FDA	2026-08-10
excluded package	package	70934-065	70934-065-10	I	Inactivated by FDA	2026-08-10
excluded package	package	70934-065	70934-065-14	I	Inactivated by FDA	2026-08-10
excluded package	package	70934-065	70934-065-20	I	Inactivated by FDA	2026-08-10
excluded package	package	70934-065	70934-065-21	I	Inactivated by FDA	2026-08-10
excluded package	package	70934-065	70934-065-28	I	Inactivated by FDA	2026-08-10
excluded package	package	70934-065	70934-065-30	I	Inactivated by FDA	2026-08-10
excluded package	package	70934-065	70934-065-40	I	Inactivated by FDA	2026-08-10
excluded package	package	70934-065	70934-065-94	I	Inactivated by FDA	2026-08-10

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 · 162 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	70934-065-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-065-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-065-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-065-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-065-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-065-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-065-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-065-20	`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	70934-065-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-065-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-065-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-065-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-065-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-065-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-065-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-065-20	`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	70934-065-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-065-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-065-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-065-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-065-94	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-065-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-065-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-065-20	`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	70934-065-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-065-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-065-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-065-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-065-94	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-065-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-065-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-065-20	`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	70934-065-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-065-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-065-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-065-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-065-94	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-065-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-065-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-065-20	`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	70934-065-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-065-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-065-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-065-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-065-94	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-065-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-065-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-065-20	`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	70934-065-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-065-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-065-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-065-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-065-94	`302b2466d912…`	`e7b80fea0513…`

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
A065229-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2005-11-25
A065229-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2005-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065229-001	AB
A065229-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065229-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065229-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-25	`782e0a99824c…`

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
2026-02-19 14:30 UTC	2026-02	A065229-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065229-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065229-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065229-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065229-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065229-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065229-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065229-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065229-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065229-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065229-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065229-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065229-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065229-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065229-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065229-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065229-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065229-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065229-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065229-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065229-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065229-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065229-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065229-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065229-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065229-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065229-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065229-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065229-002	AB	1	`782e0a99824c…`

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
70934-065-10	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-14	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-20	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-21	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-28	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-30	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-40	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971
70934-065-94	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEPHALEXIN CAPSULES USP safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES USP CEPHALEXIN capsules USP, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70934-065-10	Cephalexin	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	5
70934-065-14	Cephalexin	14 in 1 BOTTLE, PLASTIC	CAPSULE	14	5
70934-065-20	Cephalexin	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	5
70934-065-21	Cephalexin	1 in 1 BOTTLE, PLASTIC	CAPSULE	1	5
70934-065-28	Cephalexin	28 in 1 BOTTLE, PLASTIC	CAPSULE	28	5
70934-065-30	Cephalexin	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	5
70934-065-40	Cephalexin	40 in 1 BOTTLE, PLASTIC	CAPSULE	40	5
70934-065-94	Cephalexin	30 in 1 DOSE PACK	CAPSULE	30	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70934-065-20	EA - Each	70934-065	af1935e4-ef21-4d06-90ba-37a7b8fc3d83	1	2022-11-07
70934-065-30	EA - Each	70934-065	394e68c8-0a70-4b35-81df-b51b6b1089fe	1	2022-01-06
70934-065-40	EA - Each	70934-065	8c244c1a-c1d8-4ab4-894b-4e20a8554f2c	1	2021-10-08
70934-065-94	EA - Each	70934-065	b5ea0d9a-7035-4e26-a498-f517f8dc9469	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-065	CEPHALEXIN CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	5	Legacy NDC, 8 package rows	20200319_6440351e-065f-59da-e053-2a91aa0aa4c5.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	b3bb8222-161e-4d9c-8e08-7e22ad65bf72	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	8499aa5a-49b1-4555-bd27-6177d92b261d	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Coupler LLC	508a3401-df0b-0555-e063-6294a90a155a	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Sportpharm LLC	3d5a2665-65da-4b10-9e23-39fc88145da1	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	13444dc7-7da1-4181-a9ac-d95d4a235e6d	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Lupin Pharmaceuticals, Inc.	1d3e6d33-5dc2-498e-8efa-e3c4fca15dff	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af4abf8b-22cc-da58-e053-2a95a90aa766	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	a33280d4-7caf-f74b-e053-2a95a90a90c3	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc	945552cb-90e4-41fb-afe2-8ee8785e94da	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	20f8cc57-231c-4d36-a209-ff9e5735d65c	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	728c5212-dbd8-8df5-e053-2a91aa0a9579	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af10128f-021a-14b7-e053-2a95a90a4365	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	6032b68f-16d8-41b6-bd2c-86d5406a757a	2022-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229
Cephalexin	CEPHALEXIN	Proficient Rx LP	dec3a1ef-1e85-4236-804b-e7a343d3a58f	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065229 application number: ANDA065229

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	6440351e-065f-59da-e053-2a91aa0aa4c5	5
309114	cephalexin 500 MG Oral Capsule	SCD	6440351e-065f-59da-e053-2a91aa0aa4c5	5
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	6440351e-065f-59da-e053-2a91aa0aa4c5	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-065-10	70934006510	10 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-10)	10 capsule	2020-02-05	0000-00-00	No	No	Current
70934-065-14	70934006514	14 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-14)	14 capsule	2020-02-05	0000-00-00	No	No	Current
70934-065-20	70934006520	20 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-20)	20 capsule	2019-12-12	0000-00-00	No	No	Current
70934-065-21	70934006521	1 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-21)	1 capsule	2020-02-05	0000-00-00	No	No	Current
70934-065-28	70934006528	28 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-28)	28 capsule	2020-02-05	0000-00-00	No	No	Current
70934-065-30	70934006530	30 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-30)	30 capsule	2019-11-06	0000-00-00	No	No	Current
70934-065-40	70934006540	40 CAPSULE in 1 BOTTLE, PLASTIC (70934-065-40)	40 capsule	2019-09-09	0000-00-00	No	No	Current
70934-065-94	70934006594	30 CAPSULE in 1 DOSE PACK (70934-065-94)	30 capsule	2018-01-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cephalexin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-03-18	HUMAN PRESCRIPTION DRUG LABEL	5