CEFPODOXIME PROXETIL

Product NDC: 55289-393
11-digit product format: 552890393
Labeler code: 55289
Product ID: 55289-393_dd0401d5-c552-7684-e053-2995a90aafbe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEFPODOXIME PROXETIL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA065370
Marketing category: ANDA
Marketing start: 2007-06-11
Marketing end: 0000-00-00
Substance: CEFPODOXIME PROXETIL
Active strength: 200 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	55289-393		D	Discontinued by firm		2026-08-17
excluded package	package	55289-393	55289-393-02	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	55289-393		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55289-393	55289-393-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	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…`
2022-03-09 01:35 UTC	2022-03	A065370-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065370-002	AB	1	`bb7c543d1eb4…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-393-02	EA - Each	55289-393	dc09623b-695b-4101-b57e-4410b716f938	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFPODOXIME PROXETIL	ACTIVE INGREDIENT	2TB00A1Z7N	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
CEFPODOXIME	ACTIVE MOIETY	7R4F94TVGY	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55289-393	CEFPODOXIME PROXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	16	Legacy NDC	20241012_8b7f7043-5bfb-47a5-80cb-4f3f65358dff.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-393-02	55289039302	2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-393-02)	2010-06-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefpodoxime Proxetil Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	16