Application 062775

Type: ANDA
Sponsor: BARR

Application Products#

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062775-001	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL			1987-04-22

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062775-001	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	1987-04-22	`f41ea6bd6efb…`

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 6 of 8 · 151 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	f4ced8c7-a276-4a44-a60c-f8d1689a2bdf	2024-07-26	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	6e5f9616-ddf2-19c4-e053-2991aa0a372a	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	ada33464-b416-9ac6-e053-2a95a90af787	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	ade02343-3e4b-b1f1-e053-2995a90ac5fe	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	a33280d4-7caf-f74b-e053-2a95a90a90c3	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc	945552cb-90e4-41fb-afe2-8ee8785e94da	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	3fcb3f88-9dfc-444d-952a-1d1967720525	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	4eb58a7e-1c92-4be3-b702-e522e0fbf425	2024-06-21	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Asclemed USA, Inc.	20f8cc57-231c-4d36-a209-ff9e5735d65c	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	90a76d24-e5a9-9000-e053-2a95a90ae8af	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	6be20569-df34-04d9-e053-2991aa0a94fd	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	728c5212-dbd8-8df5-e053-2a91aa0a9579	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	681c235f-6dee-1401-e053-2991aa0addc0	2024-06-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	73920373-b45d-45d6-b183-d962467dde36	2024-05-24	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	fc426d0d-9774-4189-8d83-89aa85d926bb	2024-05-22	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	712a6789-7aab-4114-ae92-d1c7686c6b96	2024-05-16	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	A-S Medication Solutions	5b7666f3-4014-45ce-8387-3298d9fe6d25	2024-05-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
cephalexin	CEPHALEXIN	NuCare Pharmaceuticals,Inc.	141bd050-5dfc-68fa-e063-6394a90a6d86	2024-03-20	Warnings, Adverse reactions	Name fallback brand name: cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	ADVANCED RX PHARMACY OF TENNESSEE, LLC	af49507d-254f-296d-e053-2a95a90ad263	2024-03-12	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN

Reported adverse events (FAERS/openFDA)#

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