Cephalexin

Product NDC: 67877-255
11-digit product format: 678770255
Labeler code: 67877
Product ID: 67877-255_b0eb4846-bf8b-4322-b8c6-bfb2c252d5d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA090836
Marketing category: ANDA
Marketing start: 2012-06-04
Substance: CEPHALEXIN
Active strength: 750 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090836-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20
A090836-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20
A090836-003	CEPHALEXIN	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29
A090836-004	CEPHALEXIN	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090836-001	AB
A090836-002	AB
A090836-004	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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		2010-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		2010-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-003	CEPHALEXIN	EQ 333MG BASE	CAPSULE / ORAL			2013-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-004	CEPHALEXIN	EQ 750MG BASE	CAPSULE / ORAL	AB	RS	2013-03-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090836-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090836-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090836-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090836-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090836-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090836-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090836-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090836-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090836-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090836-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090836-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090836-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090836-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090836-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090836-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090836-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090836-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090836-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090836-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090836-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090836-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090836-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090836-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090836-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090836-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090836-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090836-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090836-001	AB	1	`301d65b070ca…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEPHALEXIN	750 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309112	Internal RxNorm lookup
309114	Internal RxNorm lookup
637173	Internal RxNorm lookup
645617	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
4fec8daf-6e09-4153-926f-64709dbdd26c	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
67877-255-01	Cephalexin	100 in 1 BOTTLE	CAPSULE	100	28
67877-255-05	Cephalexin	500 in 1 BOTTLE	CAPSULE	500	28
67877-255-10	Cephalexin	1000 in 1 BOTTLE	CAPSULE	1000	28
67877-255-20	Cephalexin	20 in 1 BOTTLE	CAPSULE	20	28
67877-255-23	Cephalexin	50 in 1 BOTTLE	CAPSULE	50	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-255-20	EA - Each	67877-255	a6871156-88de-4c1d-9f5f-f43dd267ac85	1	2013-06-04
67877-255-23	EA - Each	67877-255	1f6106b9-c4b3-4f6c-bb00-57622fd07323	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-255	CEPHALEXIN CAPSULE [ASCEND LABORATORIES, LLC]	28	Current NDC, Legacy NDC, 5 package rows	20220702_4fec8daf-6e09-4153-926f-64709dbdd26c.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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Northwind Health Company, LLC	4ecf9314-76e2-c270-e063-6294a90ad8db	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	HAWAII REPACK, INC.	d54abc0a-3c8f-4f02-bd55-406f0c5b925a	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	864d2046-b2c8-415c-814b-512bc4901c76	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	c600a2c0-42ab-4be8-b9b1-59ba39494b3f	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	af3e9919-3812-4917-bb6e-266a692ee4ab	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	a24a3c7c-c0f8-4107-ab30-751bea743d2d	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	3dc725a0-6e4b-45c6-9569-34ef65455845	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	e4e1ebcf-b43b-4dbe-9295-eeef67ba6272	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	d3527c0a-94e4-46a2-be77-d936abcd19ec	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	a6b5edf2-1ef8-46b7-977a-8c303900f3f0	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	0384c418-b4d4-4c06-9ed9-13e864b1980b	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	d6954168-9c7f-4a6c-9262-2e6bed5c9f24	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	7508351d-69fe-457c-b450-9a2343be2587	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	980b9dd9-cb61-4c4f-81ac-85ee5a7c2497	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	759c3856-8d3a-4036-926c-8508b573c736	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	5b9b212a-3a3e-4637-b23c-6d66d8cf1171	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	11cfefee-d75e-430c-8817-02dc57de0e88	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	43ca66ae-2ada-412d-bc5d-f53602f535a5	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	cf1c5d03-eddc-463a-84ad-4d59362c2cf8	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836
Cephalexin	CEPHALEXIN	Ascend Laboratories, LLC	4fec8daf-6e09-4153-926f-64709dbdd26c	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090836 application number: ANDA090836 ndc (product): 67877-255

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
637173	cephalexin 750 MG Oral Capsule	PSN	43ca66ae-2ada-412d-bc5d-f53602f535a5	104
637173	cephalexin 750 MG Oral Capsule	PSN	11cfefee-d75e-430c-8817-02dc57de0e88	104
637173	cephalexin 750 MG Oral Capsule	SCD	11cfefee-d75e-430c-8817-02dc57de0e88	104
637173	cephalexin 750 MG Oral Capsule	SCD	43ca66ae-2ada-412d-bc5d-f53602f535a5	104
637173	cephalexin 750 MG Oral Capsule	PSN	31afe835-8ec8-4ac0-8a2a-c3e9283fa6ea	102
637173	cephalexin 750 MG Oral Capsule	SCD	31afe835-8ec8-4ac0-8a2a-c3e9283fa6ea	102
637173	cephalexin 750 MG Oral Capsule	PSN	ea10d05a-2e39-4a30-8935-5555bc1e515e	101
637173	cephalexin 750 MG Oral Capsule	PSN	9a1f2ab7-d8af-444f-96c2-56b666d4c79a	101
637173	cephalexin 750 MG Oral Capsule	SCD	ea10d05a-2e39-4a30-8935-5555bc1e515e	101
637173	cephalexin 750 MG Oral Capsule	SCD	9a1f2ab7-d8af-444f-96c2-56b666d4c79a	101
309112	cephalexin 250 MG Oral Capsule	PSN	4fec8daf-6e09-4153-926f-64709dbdd26c	28
645617	cephalexin 333 MG Oral Capsule	PSN	4fec8daf-6e09-4153-926f-64709dbdd26c	28
309114	cephalexin 500 MG Oral Capsule	PSN	4fec8daf-6e09-4153-926f-64709dbdd26c	28
637173	cephalexin 750 MG Oral Capsule	PSN	4fec8daf-6e09-4153-926f-64709dbdd26c	28
309112	cephalexin 250 MG Oral Capsule	SCD	4fec8daf-6e09-4153-926f-64709dbdd26c	28
645617	cephalexin 333 MG Oral Capsule	SCD	4fec8daf-6e09-4153-926f-64709dbdd26c	28
309114	cephalexin 500 MG Oral Capsule	SCD	4fec8daf-6e09-4153-926f-64709dbdd26c	28
637173	cephalexin 750 MG Oral Capsule	SCD	4fec8daf-6e09-4153-926f-64709dbdd26c	28
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	4fec8daf-6e09-4153-926f-64709dbdd26c	28
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	4fec8daf-6e09-4153-926f-64709dbdd26c	28
309112	cephalexin 250 MG Oral Capsule	PSN	8073f183-e11f-41af-8bd1-1505bc7e044b	1
645617	cephalexin 333 MG Oral Capsule	PSN	8073f183-e11f-41af-8bd1-1505bc7e044b	1
309114	cephalexin 500 MG Oral Capsule	PSN	8073f183-e11f-41af-8bd1-1505bc7e044b	1
637173	cephalexin 750 MG Oral Capsule	PSN	8073f183-e11f-41af-8bd1-1505bc7e044b	1
309112	cephalexin 250 MG Oral Capsule	SCD	8073f183-e11f-41af-8bd1-1505bc7e044b	1
645617	cephalexin 333 MG Oral Capsule	SCD	8073f183-e11f-41af-8bd1-1505bc7e044b	1
309114	cephalexin 500 MG Oral Capsule	SCD	8073f183-e11f-41af-8bd1-1505bc7e044b	1
637173	cephalexin 750 MG Oral Capsule	SCD	8073f183-e11f-41af-8bd1-1505bc7e044b	1
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	8073f183-e11f-41af-8bd1-1505bc7e044b	1
309112	cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule	SY	8073f183-e11f-41af-8bd1-1505bc7e044b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-255-01	67877025501	100 CAPSULE in 1 BOTTLE (67877-255-01)	100 capsule	2012-06-04	0000-00-00	No	No	Current
67877-255-05	67877025505	500 CAPSULE in 1 BOTTLE (67877-255-05)	500 capsule	2012-06-04	0000-00-00	No	No	Current
67877-255-10	67877025510	1000 CAPSULE in 1 BOTTLE (67877-255-10)	1000 capsule	2012-06-04	0000-00-00	No	No	Current
67877-255-20	67877025520	20 CAPSULE in 1 BOTTLE (67877-255-20)	20 capsule	2012-06-04	0000-00-00	No	No	Current
67877-255-23	67877025523	50 CAPSULE in 1 BOTTLE (67877-255-23)	50 capsule	2012-06-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cephalexin	HAWAII REPACK, INC.	2026-08-18	HUMAN PRESCRIPTION DRUG LABEL	2
Cephalexin	Bryant Ranch Prepack	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	105
Cephalexin	Bryant Ranch Prepack	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	105
Cephalexin	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2026-06-17	Human Prescription Drug Label	29
Cephalexin	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	102
Cephalexin	Bryant Ranch Prepack	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	101
Cephalexin	Bryant Ranch Prepack	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	101
Cephalexin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-09-01	HUMAN PRESCRIPTION DRUG LABEL	1