Cefprozil

Product NDC: 57237-034
Requested package NDC: 57237-034-01
11-digit product format: 572370034
Labeler code: 57237
Product ID: 57237-034_2288a04a-b86b-4c3b-8e12-e61531cf5b43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefprozil
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA065381
Marketing category: ANDA
Marketing start: 2007-01-30
Substance: CEFPROZIL
Active strength: 125 mg/5mL
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
A065381-001	CEFPROZIL	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-01-30
A065381-002	CEFPROZIL	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065381-001	AB
A065381-002	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	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A065381-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065381-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065381-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065381-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065381-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065381-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065381-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065381-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065381-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065381-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065381-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065381-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065381-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065381-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065381-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065381-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065381-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065381-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065381-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065381-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065381-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A065381-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065381-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065381-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065381-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065381-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065381-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065381-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065381-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065381-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065381-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065381-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065381-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065381-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065381-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065381-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065381-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065381-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065381-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065381-002	AB	1	`f41ea6bd6efb…`

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: Cefprozil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFPROZIL	125 mg/5mL

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
309080	Internal RxNorm lookup
309081	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
d7fac9cc-30e1-4762-a01b-04f1bd3b2a56	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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57237-034-01	Cefprozil	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	7
57237-034-50	Cefprozil	50 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	50	7
57237-034-75	Cefprozil	75 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	75	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-034-01	ML - Milliliter	57237-034	e21e9d1a-0a71-4512-87b0-b60a0719672c	1	2014-04-03
57237-034-50	ML - Milliliter	57237-034	5a572c97-17d8-4615-8ddc-c4c37eabd011	1	2014-04-03
57237-034-75	ML - Milliliter	57237-034	c3390d4e-cd12-4de7-9fae-edaf960ca916	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFPROZIL	ACTIVE INGREDIENT	4W0459ZA4V	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
CEFPROZIL ANHYDROUS	ACTIVE MOIETY	1M698F4H4E	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-034	CEFPROZIL POWDER, FOR SUSPENSION [RISING PHARMA HOLDINGS, INC.]	7	Current NDC, Legacy NDC, 3 package rows	20240524_d7fac9cc-30e1-4762-a01b-04f1bd3b2a56.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	NorthStar Rx LLC	8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065381 application number: ANDA065381
Cefprozil	CEFPROZIL	Rising Pharma Holdings, Inc.	d7fac9cc-30e1-4762-a01b-04f1bd3b2a56	2024-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065381 application number: ANDA065381 ndc (package): 57237-034-01 ndc (product): 57237-034 ndc11 (package): 57237003401
Cefprozil	CEFPROZIL	Aurobindo Pharma Limited	97675251-70b8-43bc-93ea-f9ef6bb8cb68	2024-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065381 application number: ANDA065381
Cefprozil	CEFPROZIL	A-S Medication Solutions	8e292a8d-9fd6-45fb-8fb5-d8cb25a4b46d	2024-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065381 application number: ANDA065381

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
309080	cefprozil 125 MG in 5 mL Oral Suspension	PSN	d7fac9cc-30e1-4762-a01b-04f1bd3b2a56	7
309081	cefprozil 250 MG in 5 mL Oral Suspension	PSN	d7fac9cc-30e1-4762-a01b-04f1bd3b2a56	7
309080	cefprozil 25 MG/ML Oral Suspension	SCD	d7fac9cc-30e1-4762-a01b-04f1bd3b2a56	7
309081	cefprozil 50 MG/ML Oral Suspension	SCD	d7fac9cc-30e1-4762-a01b-04f1bd3b2a56	7
309080	cefprozil 125 MG per 5 ML Oral Suspension	SY	d7fac9cc-30e1-4762-a01b-04f1bd3b2a56	7
309081	cefprozil 250 MG per 5 ML Oral Suspension	SY	d7fac9cc-30e1-4762-a01b-04f1bd3b2a56	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-034-01	57237003401	100 mL in 1 BOTTLE (57237-034-01)	100 ml	2007-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefprozil for Oral Suspension, USP Rx only	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-05-18	Human Prescription Drug Label	7