Cefpodoxime Proxetil

Product NDC: 69292-510
Requested package NDC: 69292-510-50
11-digit product format: 692920510
Labeler code: 69292
Product ID: 69292-510_849a91fa-6412-4985-a567-528c508e6815
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefpodoxime Proxetil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amici Pharmaceuticals, LLC.
Application: ANDA210568
Marketing category: ANDA
Marketing start: 2022-08-26
Marketing end: 0000-00-00
Substance: CEFPODOXIME PROXETIL
Active strength: 100 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69292-510	69292-510-50	D	Discontinued by firm		2026-08-03

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
A210568-001	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB		2022-05-18
A210568-002	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB		2022-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210568-001	AB
A210568-002	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 2 · 58 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	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A210568-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210568-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210568-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210568-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210568-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210568-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210568-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210568-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210568-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210568-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210568-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210568-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210568-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210568-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210568-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210568-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210568-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210568-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210568-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210568-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210568-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210568-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210568-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210568-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210568-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210568-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210568-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210568-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210568-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210568-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210568-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210568-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210568-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210568-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210568-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210568-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210568-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210568-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210568-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210568-002	AB	1	`9b2671bbb829…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69292-510-01	EA - Each	69292-510	57812873-8996-406b-a4e8-e2edf2616db2	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69292-510	CEFPODOXIME PROXETIL TABLET, FILM COATED [AMICI PHARMACEUTICALS, LLC.]	1	Legacy NDC	20220902_849a91fa-6412-4985-a567-528c508e6815.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	REMEDYREPACK INC.	dae9cbf2-65b5-49fa-898b-924c39b86c57	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Golden State Medical Supply, Inc.	fb313728-09f1-aff8-e053-6394a90a30a8	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	NuCare Pharmaceuticals,Inc.	fe827f61-9336-72e7-e053-6394a90af75f	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	NuCare Pharmaceuticals,Inc.	1b405104-650b-c8e3-e063-6294a90a9e8a	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Amici Pharmaceuticals, LLC.	9d6d7f50-9838-47e3-8214-53e2dbeeadea	2023-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Ascend Laboratories, LLC	ce5646cb-a450-4c2c-8499-6ecf71b12b0e	2023-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Ascend Laboratories, LLC	5d5ca5b6-282b-4683-908c-854782255739	2022-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2TB00A1Z7N	CEFPODOXIME PROXETIL	87239-81-4	CEFPODOXIME PROXETIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69292-510-50	69292051050	500 TABLET, FILM COATED in 1 BOTTLE (69292-510-50)	2022-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefpodoxime Proxetil - Amici Pharmaceuticals, LLC. \| Alkem Laboratories Limited	Amici Pharmaceuticals, LLC. \| Alkem Laboratories Limited	2022-08-25	Human Prescription Drug Label	1