Cefpodoxime Proxetil

Product NDC: 68071-3441
11-digit product format: 680713441
Labeler code: 68071
Product ID: 68071-3441_2d80b340-7ddc-adf0-e063-6294a90af485
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefpodoxime Proxetil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA210568
Marketing category: ANDA
Marketing start: 2023-02-13
Substance: CEFPODOXIME PROXETIL
Active strength: 200 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3441-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3441-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3441-2	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 60 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	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	A210568-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210568-002	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cefpodoxime Proxetil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFPODOXIME PROXETIL	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2TB00A1Z7N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309078	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
fe827f61-9336-72e7-e053-6394a90af75f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e28aad34-15f4-8358-f1eb-20900c754318	Product name	2	20230125
bd926630-c211-e651-84da-4ef72dbed2c5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-3441-2	2025-02-06	C162847	48780-1	2cef2736-9c88-d83d-e063-dadaa90ab31f	fe827f61-9336-72e7-e053-6394a90af75f
68071-3441-2	2025-01-30	C162847	48780-1	2cef2736-9c88-d83d-e063-dadaa90ab31f	fe827f61-9336-72e7-e053-6394a90af75f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3441-2	Cefpodoxime Proxetil	20 in 1 BOTTLE	TABLET, FILM COATED	20		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3441	CEFPODOXIME PROXETIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 1 package rows	20250209_fe827f61-9336-72e7-e053-6394a90af75f.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 ndc (product): 68071-3441
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309078	cefpodoxime proxetil 200 MG Oral Tablet	PSN	fe827f61-9336-72e7-e053-6394a90af75f	2
309078	cefpodoxime 200 MG Oral Tablet	SCD	fe827f61-9336-72e7-e053-6394a90af75f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3441-2	68071344102	20 TABLET, FILM COATED in 1 BOTTLE (68071-3441-2)	2023-06-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SILICON DIOXIDE - NuCare Pharmaceuticals,Inc. \| NuCare Pharmaceutuicals,Inc.	NuCare Pharmaceuticals,Inc. \| NuCare Pharmaceutuicals,Inc.	2025-02-06	HUMAN PRESCRIPTION DRUG LABEL	2