CEFPODOXIME PROXETIL

Product NDC: 69043-007
Requested package NDC: 69043-007-25
11-digit product format: 690430007
Labeler code: 69043
Product ID: 69043-007_36f0759f-b50b-4a49-869b-d73f5ad7d8cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEFPODOXIME PROXETIL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cronus Pharma LLC
Application: ANDA065370
Marketing category: ANDA
Marketing start: 2007-06-11
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

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.

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309076	Internal RxNorm lookup
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
bc9c338c-1fc7-4bc2-a357-a78e433cbe9d	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69043-007-01	CEFPODOXIME PROXETIL	100 in 1 BOTTLE	TABLET, FILM COATED	100		6
69043-007-25	CEFPODOXIME PROXETIL	250 in 1 BOTTLE	TABLET, FILM COATED	250		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69043-007	CEFPODOXIME PROXETIL TABLET, FILM COATED [CRONUS PHARMA LLC]	6	Current NDC, Legacy NDC, 2 package rows	20240106_bc9c338c-1fc7-4bc2-a357-a78e433cbe9d.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 ndc (package): 69043-007-25 ndc (product): 69043-007 ndc11 (package): 69043000725
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	bc9c338c-1fc7-4bc2-a357-a78e433cbe9d	6
309078	cefpodoxime proxetil 200 MG Oral Tablet	PSN	bc9c338c-1fc7-4bc2-a357-a78e433cbe9d	6
309076	cefpodoxime 100 MG Oral Tablet	SCD	bc9c338c-1fc7-4bc2-a357-a78e433cbe9d	6
309078	cefpodoxime 200 MG Oral Tablet	SCD	bc9c338c-1fc7-4bc2-a357-a78e433cbe9d	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69043-007-25	69043000725	250 TABLET, FILM COATED in 1 BOTTLE (69043-007-25)	2023-10-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefpodoxime Proxetil Tablets, USP Rx only	Cronus Pharma LLC \| Aurobindo Pharma Limited	2024-01-04	Human Prescription Drug Label	6