CEFPODOXIME PROXETIL

Product NDC: 68071-2742
11-digit product format: 680712742
Labeler code: 68071
Product ID: 68071-2742_e07b3225-cca0-9012-e053-2a95a90a7cab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEFPODOXIME PROXETIL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA065370
Marketing category: ANDA
Marketing start: 2007-06-11
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2742		I	Inactivated by FDA		2026-10-05
excluded package	package	68071-2742	68071-2742-1	I	Inactivated by FDA		2026-10-05

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2742-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2742-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2742-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2742-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2742-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2742-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2742-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2742-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2742-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

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
A065370-001	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB		2007-06-11
A065370-002	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB		2007-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065370-001	AB
A065370-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065370-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065370-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065370-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065370-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065370-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065370-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065370-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065370-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065370-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065370-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065370-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065370-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065370-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065370-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065370-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065370-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065370-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065370-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065370-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065370-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065370-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065370-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065370-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065370-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065370-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065370-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065370-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065370-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065370-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065370-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065370-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065370-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065370-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065370-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065370-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065370-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065370-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065370-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065370-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065370-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

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
68071-2742-1	2025-01-30	C162847	48780-1	2cef2736-7438-d83d-e063-dadaa90ab31f	Cefpodoxime Proxetil Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2742-1	CEFPODOXIME PROXETIL	10 in 1 BOTTLE	TABLET, FILM COATED	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2742	CEFPODOXIME PROXETIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20220603_e07b2d69-b206-529a-e053-2995a90a149f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Redpharm Drug	59d848e9-de7a-669b-e063-6394a90a2b35	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065370 application number: ANDA065370
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Cronus Pharma LLC	bc9c338c-1fc7-4bc2-a357-a78e433cbe9d	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065370 application number: ANDA065370
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	c36f2137-98bb-4583-89f7-6bce9582c465	2024-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065370 application number: ANDA065370
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	4587a7c1-cd6c-4946-a0dd-fcfe0c8504b9	2024-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065370 application number: ANDA065370

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
309076	cefpodoxime proxetil 100 MG Oral Tablet	PSN	e07b2d69-b206-529a-e053-2995a90a149f	1
309076	cefpodoxime 100 MG Oral Tablet	SCD	e07b2d69-b206-529a-e053-2995a90a149f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2742-1	68071274201	10 TABLET, FILM COATED in 1 BOTTLE (68071-2742-1)	2022-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefpodoxime Proxetil Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2022-06-02	HUMAN PRESCRIPTION DRUG LABEL	1