Application 065215

Type: ANDA
Sponsor: HIKMA

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
A065215-001	CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL			2006-01-24
A065215-002	CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL			2006-01-24

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	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL		2006-01-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL		2006-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2006-01-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2006-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2006-01-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2006-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2006-01-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2006-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2006-01-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2006-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065215-001	CEPHALEXIN	EQ 250MG BASE	CAPSULE / ORAL	AB	2006-01-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065215-002	CEPHALEXIN	EQ 500MG BASE	CAPSULE / ORAL	AB	2006-01-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065215-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065215-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065215-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065215-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065215-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065215-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065215-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065215-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065215-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065215-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065215-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065215-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065215-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065215-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065215-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065215-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065215-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065215-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065215-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065215-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065215-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065215-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065215-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065215-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065215-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065215-002	AB	1	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	A065215-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065215-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065215-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065215-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065215-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065215-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065215-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065215-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065215-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065215-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065215-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065215-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065215-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065215-002	AB	1	`3bdfa0b2c4d7…`

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 8 · 156 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	864d2046-b2c8-415c-814b-512bc4901c76	2026-08-12	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	c600a2c0-42ab-4be8-b9b1-59ba39494b3f	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	af3e9919-3812-4917-bb6e-266a692ee4ab	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	a24a3c7c-c0f8-4107-ab30-751bea743d2d	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	3dc725a0-6e4b-45c6-9569-34ef65455845	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	PD-Rx Pharmaceuticals, Inc.	e4e1ebcf-b43b-4dbe-9295-eeef67ba6272	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	b73593ce-0b1f-4371-bae1-140742de3b42	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	d3527c0a-94e4-46a2-be77-d936abcd19ec	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	2506895d-f3e0-4be9-95cb-7a6fd44de46d	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	AvKARE	03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Preferred Pharmaceuticals Inc.	88426cb3-1c0c-439b-9f1a-aa169040c29f	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	REMEDYREPACK INC.	a6b5edf2-1ef8-46b7-977a-8c303900f3f0	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Aurobindo Pharma Limited	655f38e8-1c4d-4cbc-9f52-bb881f065b2d	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	0384c418-b4d4-4c06-9ed9-13e864b1980b	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	d6954168-9c7f-4a6c-9262-2e6bed5c9f24	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	7508351d-69fe-457c-b450-9a2343be2587	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	980b9dd9-cb61-4c4f-81ac-85ee5a7c2497	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	759c3856-8d3a-4036-926c-8508b573c736	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	5b9b212a-3a3e-4637-b23c-6d66d8cf1171	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN
Cephalexin	CEPHALEXIN	Bryant Ranch Prepack	11cfefee-d75e-430c-8817-02dc57de0e88	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Cephalexin generic name: CEPHALEXIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9897	Cephalexin	Cephalexin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9897	Cephalexin	Cephalexin	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9898	Cephalexin	Cephalexin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9898	Cephalexin	Cephalexin	West-Ward Pharmaceuticals Corp	ANDA	Current
0440-1243	Cephalexin	Cephalexin	Liberty Pharmaceuticals, Inc.	ANDA	Current
10544-066	Cephalexin	Cephalexin	Blenheim Pharmacal, Inc.	ANDA	Current
10544-617	Cephalexin	Cephalexin	Blenheim Pharmacal, Inc.	ANDA	Current
52959-031	Cephalexin	Cephalexin	H.J. Harkins Company, Inc.	ANDA	Current
61786-277	Cephalexin	Cephalexin	REMEDYREPACK INC.	ANDA	Current
63874-111	Cephalexin	Cephalexin	Altura Pharmaceuticals, Inc.	ANDA	Current
63874-112	Cephalexin	Cephalexin	Altura Pharmaceuticals, Inc.	ANDA	Current
66116-398	Cephalexin	Cephalexin	MedVantx, Inc.	ANDA	Current