Cefpodoxime Proxetil

Product NDC: 16714-402
Requested package NDC: 16714-402-01
11-digit product format: 167140402
Labeler code: 16714
Product ID: 16714-402_3c3d4973-bfda-476f-b094-52ac4648d7f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefpodoxime Proxetil
Dosage form: GRANULE, FOR SUSPENSION
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA065409
Marketing category: ANDA
Marketing start: 2007-06-08
Substance: CEFPODOXIME PROXETIL
Active strength: 50 mg/5mL
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
A065409-001	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL			2007-06-08
A065409-002	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		RS	2007-06-08

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065409-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL		2007-06-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065409-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	RS	2007-06-08	`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	50 mg/5mL

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
309077	Internal RxNorm lookup
309079	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
5310de78-22c3-4bee-9956-854e767b6bef	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	SPL version
16714-402-01	Cefpodoxime Proxetil	1 in 1 CARTON	GRANULE, FOR SUSPENSION	1	7
16714-402-01	Cefpodoxime Proxetil	50 mL in 1 BOTTLE	GRANULE, FOR SUSPENSION	50	7
16714-402-02	Cefpodoxime Proxetil	1 in 1 CARTON	GRANULE, FOR SUSPENSION	1	7
16714-402-02	Cefpodoxime Proxetil	100 mL in 1 BOTTLE	GRANULE, FOR SUSPENSION	100	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-402-01	ML - Milliliter	16714-402	36d02003-ba9f-47d8-b39d-dc814025eecd	1	2013-03-03
16714-402-02	ML - Milliliter	16714-402	6cbc39b6-25af-401e-a932-8cbe1d292d77	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFPODOXIME PROXETIL	ACTIVE INGREDIENT	2TB00A1Z7N	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
CEFPODOXIME	ACTIVE MOIETY	7R4F94TVGY	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-402	CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC]	7	Current NDC, Legacy NDC, 4 package rows	20240105_5310de78-22c3-4bee-9956-854e767b6bef.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	Rising Pharma Holdings, Inc.	edf589b2-f796-4522-a5e6-2bd0a833922f	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065409 application number: ANDA065409
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	NorthStar Rx LLC	5310de78-22c3-4bee-9956-854e767b6bef	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065409 application number: ANDA065409 ndc (package): 16714-402-01 ndc (product): 16714-402 ndc11 (package): 16714040201
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	63777889-d306-4fc3-88da-b24859040ef4	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065409 application number: ANDA065409

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
309077	cefpodoxime 100 MG in 5 mL Oral Suspension	PSN	5310de78-22c3-4bee-9956-854e767b6bef	7
309079	cefpodoxime 50 MG in 5 mL Oral Suspension	PSN	5310de78-22c3-4bee-9956-854e767b6bef	7
309079	cefpodoxime 10 MG/ML Oral Suspension	SCD	5310de78-22c3-4bee-9956-854e767b6bef	7
309077	cefpodoxime 20 MG/ML Oral Suspension	SCD	5310de78-22c3-4bee-9956-854e767b6bef	7
309077	cefpodoxime (as cefpodoxime proxetil) 100 MG per 5 ML Oral Suspension	SY	5310de78-22c3-4bee-9956-854e767b6bef	7
309079	cefpodoxime (as cefpodoxime proxetil) 50 MG per 5 ML Oral Suspension	SY	5310de78-22c3-4bee-9956-854e767b6bef	7
309077	cefpodoxime 100 MG per 5 ML Oral Suspension	SY	5310de78-22c3-4bee-9956-854e767b6bef	7
309079	cefpodoxime 50 MG per 5 ML Oral Suspension	SY	5310de78-22c3-4bee-9956-854e767b6bef	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-402-01	16714040201	1 BOTTLE in 1 CARTON (16714-402-01) / 50 mL in 1 BOTTLE	1 bottle	2007-06-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefpodoxime Proxetil - NorthStar Rx LLC \| Aurobindo Pharma Limited	NorthStar Rx LLC \| Aurobindo Pharma Limited	2024-01-04	Human Prescription Drug Label	7