Cefprozil

Product NDC: 67296-1180
11-digit product format: 672961180
Labeler code: 67296
Product ID: 67296-1180_d60ff571-d1c8-0675-e053-2995a90a15aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefprozil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA065340
Marketing category: ANDA
Marketing start: 2007-05-24
Marketing end: 0000-00-00
Substance: CEFPROZIL
Active strength: 500 mg/1
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	67296-1180		I	Inactivated by FDA		2026-10-05
excluded package	package	67296-1180	67296-1180-2	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 · 10 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
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1180-2	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1180-2	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1180-2	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1180-2	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1180-2	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A065340-001	CEFPROZIL	CEFPROZIL	250MG	TABLET / ORAL	AB		2007-05-24
A065340-002	CEFPROZIL	CEFPROZIL	500MG	TABLET / ORAL	AB		2007-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065340-001	AB
A065340-002	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	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`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	A065340-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065340-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065340-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065340-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065340-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065340-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065340-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065340-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065340-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065340-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065340-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065340-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065340-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065340-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065340-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065340-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065340-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065340-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065340-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065340-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065340-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065340-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065340-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065340-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065340-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065340-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065340-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065340-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065340-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065340-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065340-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065340-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065340-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065340-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065340-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065340-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065340-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065340-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065340-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065340-002	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
228ef569-e7f1-4dcf-b820-c09522f86f2e	Product name	1	20250129

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1180-2	2026-01-29	C162847	48780-1	1030e364-ff94-111a-e063-dadaa90a10e2	4ec8c25f-a8c3-63da-e054-00144ff8d46c
67296-1180-2	2024-07-15	C162847	48780-1	1030e364-ff94-111a-e063-dadaa90a10e2	4ec8c25f-a8c3-63da-e054-00144ff8d46c
67296-1180-2	2024-01-30	C162847	48780-1	1030e364-ff94-111a-e063-dadaa90a10e2	4ec8c25f-a8c3-63da-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1180-2	Cefprozil	20 in 1 BOTTLE	TABLET, FILM COATED	20		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1180	CEFPROZIL TABLET, FILM COATED [REDPHARM DRUG, INC.]	4	Legacy NDC, 1 package rows	20240716_4ec8c25f-a8c3-63da-e054-00144ff8d46c.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
Cefprozil	CEFPROZIL	A-S Medication Solutions	d5d28d57-1f3c-4c80-ad78-0f67635f5428	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065340 application number: ANDA065340
Cefprozil	CEFPROZIL	NorthStar Rx LLC	6133611e-19c1-4df2-8c23-8573aaf63020	2024-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065340 application number: ANDA065340
Cefprozil	CEFPROZIL	Aurobindo Pharma Limited	b9111a81-07c4-4458-b994-a4ad504986d8	2024-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065340 application number: ANDA065340
Cefprozil	CEFPROZIL	Rising Pharma Holdings, Inc.	af24a86f-8072-49a6-94ec-2f17fe81812b	2024-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065340 application number: ANDA065340

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4W0459ZA4V	CEFPROZIL	121123-17-9	CEFPROZIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197453	cefprozil 500 MG Oral Tablet	PSN	4ec8c25f-a8c3-63da-e054-00144ff8d46c	4
197453	cefprozil 500 MG Oral Tablet	SCD	4ec8c25f-a8c3-63da-e054-00144ff8d46c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1180-2	67296118002	20 TABLET, FILM COATED in 1 BOTTLE (67296-1180-2)	2007-05-24	0000-00-00	No	No	Current