Cephalexin

Product NDC: 55289-058
11-digit product format: 552890058
Labeler code: 55289
Product ID: 55289-058_4304de4b-4197-e324-e063-6394a90ad3d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA062702
Marketing category: ANDA
Marketing start: 1990-09-30
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

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
A062702-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		1987-02-13
A062702-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		1987-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062702-001	AB
A062702-002	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	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062702-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1987-02-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062702-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1987-02-13	`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	A062702-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062702-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062702-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062702-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062702-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062702-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062702-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062702-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062702-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062702-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062702-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062702-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062702-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062702-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062702-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062702-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062702-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062702-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062702-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062702-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062702-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062702-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062702-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062702-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062702-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062702-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062702-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062702-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062702-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062702-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062702-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062702-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062702-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062702-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062702-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062702-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062702-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062702-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062702-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062702-002	AB	1	`782e0a99824c…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
6ce11859-aa21-4b3f-bd59-3cd26deca82b	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
55289-058-10	Cephalexin	10 in 1 BOTTLE, PLASTIC	CAPSULE	10	25
55289-058-14	Cephalexin	14 in 1 BOTTLE, PLASTIC	CAPSULE	14	25
55289-058-20	Cephalexin	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	25
55289-058-28	Cephalexin	28 in 1 BOTTLE, PLASTIC	CAPSULE	28	25
55289-058-30	Cephalexin	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	25
55289-058-40	Cephalexin	40 in 1 BOTTLE, PLASTIC	CAPSULE	40	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-058-04	EA - Each	55289-058	b86f91d2-ecd4-4bbc-80d3-ea47129bd30f	1	2012-07-24
55289-058-08	EA - Each	55289-058	3ca02006-349c-42d5-8fb8-e36d3cd2c8ca	1	2012-07-24
55289-058-10	EA - Each	55289-058	b087d70b-6a40-4f33-8795-97d27d1dd03b	1	2012-07-24
55289-058-14	EA - Each	55289-058	2b36b440-d059-409d-a87b-b266c50d3a7a	1	2012-07-24
55289-058-20	EA - Each	55289-058	35d2e2fa-2b17-4d6f-8037-728b75a0acd8	1	2012-07-24
55289-058-21	EA - Each	55289-058	554a729c-7c3b-48c1-9e1e-6865938dd5d7	1	2012-07-24
55289-058-24	EA - Each	55289-058	def5bb03-52fb-4e47-83d0-ee22189f5e27	1	2012-07-24
55289-058-28	EA - Each	55289-058	56b5b7e5-03c2-4e11-9c76-9658adec9192	1	2012-07-24
55289-058-30	EA - Each	55289-058	6aaa7394-5e23-4304-bde0-e9613d519617	1	2012-07-24
55289-058-40	EA - Each	55289-058	054b394d-0441-4fee-a758-9cfd3be85e74	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55289-058	CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]	23	Current NDC, Legacy NDC, 6 package rows	20241011_6ce11859-aa21-4b3f-bd59-3cd26deca82b.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.	b73593ce-0b1f-4371-bae1-140742de3b42	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	Unit Dose Solutions, Inc.	53704ffd-b4f6-8b61-e063-6394a90a01f9	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	ad676021-44f3-4a97-a3dc-28a62fe982bb	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	3fed2817-fc0d-43cd-9f02-948fbc76672c	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	AVKARE	74f83298-57f7-4166-8dd8-db3e556a68d8	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	QPharma Inc	e8b3ece4-cf73-416c-8767-68f425df35f8	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	QPharma Inc	4e9a8ed3-c490-4a0e-bb29-5eea506f893b	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	6ce11859-aa21-4b3f-bd59-3cd26deca82b	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702 ndc (product): 55289-058
Cephalexin	CEPHALEXIN	A-S Medication Solutions	bff3912c-c39c-40c0-98d2-27c3d506c24d	2025-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	ade02343-3e4b-b1f1-e053-2995a90ac5fe	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	A-S Medication Solutions	fc426d0d-9774-4189-8d83-89aa85d926bb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	A-S Medication Solutions	5b7666f3-4014-45ce-8387-3298d9fe6d25	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	18518154-30ba-48a4-852a-3a7723030071	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	Proficient Rx LP	ada7b8a5-98f4-454c-b38f-92192d4db33f	2021-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702
Cephalexin	CEPHALEXIN	Teva Pharmaceuticals USA, Inc.	19307ff0-71de-477b-965d-ea243e5ede3a	2020-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062702 application number: ANDA062702

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	6ce11859-aa21-4b3f-bd59-3cd26deca82b	25
309114	cephalexin 500 MG Oral Capsule	SCD	6ce11859-aa21-4b3f-bd59-3cd26deca82b	25
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	6ce11859-aa21-4b3f-bd59-3cd26deca82b	25

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-058-04	55289005804	4 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-04)	4 capsule	2011-06-06	0000-00-00	No	No	Current
55289-058-08	55289005808	8 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-08)	8 capsule	2011-06-06	0000-00-00	No	No	Current
55289-058-10	55289005810	10 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-10)	10 capsule	2011-06-06	0000-00-00	No	No	Current
55289-058-14	55289005814	14 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-14)	14 capsule	2011-06-06	0000-00-00	No	No	Current
55289-058-20	55289005820	20 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-20)	20 capsule	2011-06-06	0000-00-00	No	No	Current
55289-058-21	55289005821	21 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-21)	21 capsule	2011-06-06	0000-00-00	No	No	Current
55289-058-24	55289005824	24 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-24)	24 capsule	2011-06-06	0000-00-00	No	No	Current
55289-058-28	55289005828	28 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-28)	28 capsule	2011-06-06	0000-00-00	No	No	Current
55289-058-30	55289005830	30 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-30)	30 capsule	2011-06-06	0000-00-00	No	No	Current
55289-058-40	55289005840	40 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-40)	40 capsule	2011-06-06	0000-00-00	No	No	Current