Application 062713

Type: ANDA
Sponsor: BELCHER PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEPHALEXIN	CEPHALEXIN	CAPSULE;ORAL	EQ 250MG BASE	No	No
002	CEPHALEXIN	CEPHALEXIN	CAPSULE;ORAL	EQ 500MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A062713-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB		1988-07-15
A062713-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB		1988-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062713-001	AB
A062713-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062713-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	1988-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062713-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	1988-07-15	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A062713-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062713-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062713-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062713-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062713-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062713-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062713-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062713-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062713-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062713-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062713-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062713-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062713-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062713-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062713-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062713-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062713-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062713-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062713-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062713-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062713-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062713-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062713-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062713-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062713-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062713-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062713-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062713-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062713-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062713-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062713-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062713-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062713-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062713-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062713-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062713-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062713-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062713-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062713-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062713-002	AB	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	AvKARE	03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062713 application number: ANDA062713 ndc (product): 42291-209 ndc (product): 42291-208
CEPHALEXIN	CEPHALEXIN	DIRECT RX	2d12e6a9-f7dd-25ed-e054-00144ff8d46c	2022-09-29	Warnings, Adverse reactions	Exact identifier ndc (product): 61919-522

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-082	Cephalexin	Cephalexin	Blenheim Pharmacal, Inc.	ANDA	Current
10544-868	Cephalexin	Cephalexin	Blenheim Pharmacal, Inc.	ANDA	Current
10544-945	Cephalexin	cephalexin	Blenheim Pharmacal, Inc.	ANDA	Current
10544-946	Cephalexin	cephalexin	Blenheim Pharmacal, Inc.	ANDA	Current
15749-801	Cephalexin	Cephalexin	American Antibiotics, Inc	ANDA	Current
15749-802	Cephalexin	Cephalexin	American Antibiotics, Inc	ANDA	Current
42291-208	Cephalexin	Cephalexin	AvKARE, Inc.	ANDA	Current
42291-208	Cephalexin	Cephalexin	AvKARE, Inc.	ANDA	Current
42291-208	Cephalexin	Cephalexin	AvKARE	ANDA	Current
42291-209	Cephalexin	Cephalexin	AvKARE, Inc.	ANDA	Current
42291-209	Cephalexin	Cephalexin	AvKARE, Inc.	ANDA	Current
42291-209	Cephalexin	Cephalexin	AvKARE	ANDA	Current
42582-211	Cephalexin	Cephalexin	Bi-Coastal Pharma International LLC	ANDA	Current
42582-211	Cephalexin	Cephalexin	Bi-Coastal Pharma International LLC	ANDA	Current
42582-211	Cephalexin	Cephalexin	Bi-Coastal Pharma International LLC	ANDA	Current
42582-212	Cephalexin	Cephalexin	Bi-Coastal Pharma International LLC	ANDA	Current
42582-212	Cephalexin	Cephalexin	Bi-Coastal Pharma International LLC	ANDA	Current
42582-212	Cephalexin	Cephalexin	Bi-Coastal Pharma International LLC	ANDA	Current
50090-0084	Cephalexin	Cephalexin	A-S Medication Solutions LLC	ANDA	Current
50436-1020	Cephalexin	cephalexin	Unit Dose Services	ANDA	Current
51655-025	Cephalexin	Cephalexin	Northwind Pharmaceuticals	ANDA	Current
55700-009	Cephalexin	Cephalexin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-364	Cephalexin	cephalexin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-029	CEPHALEXIN	CEPHALEXIN	DIRECT RX	ANDA	Current
61919-522	CEPHALEXIN	CEPHALEXIN	DirectRX	ANDA	Current
61919-522	CEPHALEXIN	CEPHALEXIN	DIRECT RX	ANDA	Current
61919-522	CEPHALEXIN	CEPHALEXIN	DIRECT RX	ANDA	Current
62250-801	Cephalexin	Cephalexin	Belcher Pharmaceuticals, LLC	ANDA	Current
62250-801	Cephalexin	Cephalexin	Belcher Pharmaceuticals, LLC	ANDA	Current
62250-802	Cephalexin	Cephalexin	Belcher Pharmaceuticals, LLC	ANDA	Current
62250-802	Cephalexin	Cephalexin	Belcher Pharmaceuticals, LLC	ANDA	Current
63187-287	Cephalexin	Cephalexin	Proficient Rx LP	ANDA	Current
63187-454	Cephalexin	Cephalexin	Proficient Rx LP	ANDA	Current
64205-101	Cephalexin	Cephalexin	ReadyMeds	ANDA	Current
64205-102	Cephalexin	Cephalexin	ReadyMeds	ANDA	Current
64725-0101	Cephalexin	Cephalexin	TYA Pharmaceuticals	ANDA	Current
64725-1021	Cephalexin	Cephalexin	TYA Pharmaceuticals	ANDA	Current
67296-1211	Cephalexin	Cephalexin	RedPharm Drug, Inc.	ANDA	Current
67296-1211	Cephalexin	Cephalexin	RedPharm Drug, Inc.	ANDA	Current
67296-1362	Cephalexin	Cephalexin	RedPharm Drug, Inc.	ANDA	Current
67296-1362	Cephalexin	Cephalexin	RedPharm Drug, Inc.	ANDA	Current
68788-8994	Cephalexin	cephalexin	Preferred Pharmaceuticals Inc.	ANDA	Current
69543-102	Cephalexin	cephalexin	Virtus Pharmaceuticals	ANDA	Current
69543-102	Cephalexin	cephalexin	Virtus Pharmaceuticals	ANDA	Current
69543-102	Cephalexin	cephalexin	Virtus Pharmaceuticals	ANDA	Current