Cefprozil

Product NDC: 65862-069
Requested package NDC: 65862-069-01
11-digit product format: 658620069
Labeler code: 65862
Product ID: 65862-069_6397ff45-3c37-40c3-a924-d036bb896b3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefprozil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065340
Marketing category: ANDA
Marketing start: 2007-05-24
Substance: CEFPROZIL
Active strength: 500 mg/1
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 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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`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	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…`
2022-03-09 01:35 UTC	2022-03	A065340-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065340-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cefprozil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFPROZIL	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4W0459ZA4V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197452	Internal RxNorm lookup
197453	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
b9111a81-07c4-4458-b994-a4ad504986d8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
228ef569-e7f1-4dcf-b820-c09522f86f2e	Product name	1	20250129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-069-01	Cefprozil	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
65862-069-05	Cefprozil	500 in 1 BOTTLE	TABLET, FILM COATED	500	11
65862-069-30	Cefprozil	30 in 1 BOTTLE	TABLET, FILM COATED	30	11
65862-069-50	Cefprozil	50 in 1 BOTTLE	TABLET, FILM COATED	50	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-069-01	EA - Each	65862-069	d860de18-c7ff-4779-88fc-059156fe63ff	1	2012-07-24
65862-069-50	EA - Each	65862-069	588eb842-86c6-4361-b032-bbb652e58fb6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFPROZIL	ACTIVE INGREDIENT	4W0459ZA4V	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
CEFPROZIL ANHYDROUS	ACTIVE MOIETY	1M698F4H4E	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-069	CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	11	Current NDC, Legacy NDC, 4 package rows	20240507_b9111a81-07c4-4458-b994-a4ad504986d8.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 ndc (package): 65862-069-01 ndc (product): 65862-069 ndc11 (package): 65862006901
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
197452	cefprozil 250 MG Oral Tablet	PSN	b9111a81-07c4-4458-b994-a4ad504986d8	11
197453	cefprozil 500 MG Oral Tablet	PSN	b9111a81-07c4-4458-b994-a4ad504986d8	11
197452	cefprozil 250 MG Oral Tablet	SCD	b9111a81-07c4-4458-b994-a4ad504986d8	11
197453	cefprozil 500 MG Oral Tablet	SCD	b9111a81-07c4-4458-b994-a4ad504986d8	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-069-01	65862006901	100 TABLET, FILM COATED in 1 BOTTLE (65862-069-01)	2007-05-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefprozil Tablets, USP Rx Only	Aurobindo Pharma Limited	2024-05-05	Human Prescription Drug Label	11