Cephalexin

Product NDC: 50090-0079
11-digit product format: 500900079
Labeler code: 50090
Product ID: 50090-0079_4a51af0b-3c86-49da-99b3-5fc4309b2690
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA065253
Marketing category: ANDA
Marketing start: 2005-11-16
Substance: CEPHALEXIN
Active strength: 500 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 18 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
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	50090-0079-0	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0079-8	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0079-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0079-5	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0079-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0079-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0079-7	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0079-6	`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	50090-0079-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0079-8	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0079-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0079-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0079-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0079-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0079-7	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0079-6	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065253-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16
A065253-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16
A065253-003	CEPHALEXIN	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A065253-001	AB
A065253-002	AB
A065253-003	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 · 109 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	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2005-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-003	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	2023-12-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2005-11-16	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 109 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A065253-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065253-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065253-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065253-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065253-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065253-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065253-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065253-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065253-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065253-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065253-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065253-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065253-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065253-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065253-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065253-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065253-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065253-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065253-001	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Cephalexin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEPHALEXIN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OBN7UDS42Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309112	Internal RxNorm lookup
309114	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
99ef59d5-bc44-4727-86fe-dc81357207c3	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-0079-0	Cephalexin	20 in 1 BOTTLE	CAPSULE	20	14
50090-0079-1	Cephalexin	28 in 1 BOTTLE	CAPSULE	28	14
50090-0079-2	Cephalexin	40 in 1 BOTTLE	CAPSULE	40	14
50090-0079-3	Cephalexin	14 in 1 BOTTLE	CAPSULE	14	14
50090-0079-5	Cephalexin	10 in 1 BOTTLE	CAPSULE	10	14
50090-0079-6	Cephalexin	30 in 1 BOTTLE	CAPSULE	30	14
50090-0079-7	Cephalexin	100 in 1 BOTTLE	CAPSULE	100	14
50090-0079-8	Cephalexin	4 in 1 BOTTLE	CAPSULE	4	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0079-0	EA - Each	50090-0079	a86bd7ef-77e2-4aaa-ae0e-6c08c5581fe8	1	2018-08-13
50090-0079-1	EA - Each	50090-0079	f656bf36-e4a3-4e42-babf-d26de47a29f5	1	2018-08-13
50090-0079-2	EA - Each	50090-0079	c5567324-46f6-4193-b8fe-af86bfb6be58	1	2024-12-10
50090-0079-3	EA - Each	50090-0079	5d8e71eb-941b-4817-9028-aaa4810e92d2	1	2024-12-10
50090-0079-5	EA - Each	50090-0079	0ab0e485-c9ed-49a1-9e4d-1f009d2a5a64	1	2024-12-10
50090-0079-6	EA - Each	50090-0079	e17299ba-27ba-4e3f-a2fa-daba613714ee	1	2018-08-13
50090-0079-7	EA - Each	50090-0079	d80d24ff-37fb-4c20-8081-21673815e267	1	2024-12-10
50090-0079-8	EA - Each	50090-0079	9289cb66-24ff-4ef1-8923-2d5c0e6bd6c3	1	2024-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0079	CEPHALEXIN CAPSULE [A-S MEDICATION SOLUTIONS]	14	Current NDC, Legacy NDC, 8 package rows	20241027_99ef59d5-bc44-4727-86fe-dc81357207c3.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Cronus Pharma LLC	a4e861e2-5803-4c4a-a962-92f5755e1ab5	2025-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	A-S Medication Solutions	99ef59d5-bc44-4727-86fe-dc81357207c3	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253 ndc (product): 50090-0079
Cephalexin	CEPHALEXIN	A-S Medication Solutions	65b38519-1d8a-4aca-b415-c64cca84d085	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals, Inc.	216660f3-0329-ef7d-e063-6294a90a17df	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	Proficient Rx LP	e43271ef-c145-4145-b7f0-a02c237de2b5	2024-08-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af49507d-254f-296d-e053-2a95a90ad263	2024-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065253 application number: ANDA065253

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
309112	cephalexin 250 MG Oral Capsule	PSN	99ef59d5-bc44-4727-86fe-dc81357207c3	14
309114	cephalexin 500 MG Oral Capsule	PSN	99ef59d5-bc44-4727-86fe-dc81357207c3	14
309112	cephalexin 250 MG Oral Capsule	SCD	99ef59d5-bc44-4727-86fe-dc81357207c3	14
309114	cephalexin 500 MG Oral Capsule	SCD	99ef59d5-bc44-4727-86fe-dc81357207c3	14
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	99ef59d5-bc44-4727-86fe-dc81357207c3	14
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	99ef59d5-bc44-4727-86fe-dc81357207c3	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-0079-0	50090007900	20 CAPSULE in 1 BOTTLE (50090-0079-0)	20 capsule	2014-11-28	No	No	Current
50090-0079-1	50090007901	28 CAPSULE in 1 BOTTLE (50090-0079-1)	28 capsule	2014-11-28	No	No	Current
50090-0079-2	50090007902	40 CAPSULE in 1 BOTTLE (50090-0079-2)	40 capsule	2014-11-28	No	No	Current
50090-0079-3	50090007903	14 CAPSULE in 1 BOTTLE (50090-0079-3)	14 capsule	2014-11-28	No	No	Current
50090-0079-5	50090007905	10 CAPSULE in 1 BOTTLE (50090-0079-5)	10 capsule	2014-11-28	No	No	Current
50090-0079-6	50090007906	30 CAPSULE in 1 BOTTLE (50090-0079-6)	30 capsule	2014-11-28	No	No	Current
50090-0079-7	50090007907	100 CAPSULE in 1 BOTTLE (50090-0079-7)	100 capsule	2014-11-28	No	No	Current
50090-0079-8	50090007908	4 CAPSULE in 1 BOTTLE (50090-0079-8)	4 capsule	2014-11-28	No	No	Current