NDC 55566-2800-0 - CERVIDIL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 55566-2800
Requested NDC: 55566-2800-0
Package NDCs from labels: 55566-2800-0, 55566-2800-1
Manufacturer: Ferring Pharmaceuticals Inc. | Ferring Controlled Therapeutics Ltd | EUROAPI Hungary Ltd. | Kyowa Pharma Chemical Co., Ltd.
Effective date: 2023-06-02
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
CERVIDIL	Ferring Pharmaceuticals Inc. \| Ferring Controlled Therapeutics Ltd \| EUROAPI Hungary Ltd. \| Kyowa Pharma Chemical Co., Ltd.	2023-06-02	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55566-2800-0	CERVIDIL	10 mg in 1 POUCH	INSERT	10		10
55566-2800-1	CERVIDIL	1 in 1 CARTON	INSERT	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55566-2800	CERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]	10	Current NDC, Legacy NDC, 2 package rows	20230607_f3bc9031-0620-4a50-b440-f661cadfeb1d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55566-2800-1	EA - Each	55566-2800	32d9ee4b-22fb-4ebe-b05b-6868d45ffa8a	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DINOPROSTONE	ACTIVE INGREDIENT	K7Q1JQR04M	CERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]	2
DINOPROSTONE	ACTIVE MOIETY	K7Q1JQR04M	CERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]	2

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prepidil	DINOPROSTONE	Pharmacia & Upjohn Company LLC	ab03de5b-782c-4f81-a8dc-7ef9969dd0cf	2025-10-22	Warnings, Adverse reactions	Exact identifier unii: K7Q1JQR04M
CERVIDIL	DINOPROSTONE	Ferring Pharmaceuticals Inc.	f3bc9031-0620-4a50-b440-f661cadfeb1d	2023-06-02	Warnings, Adverse reactions	Exact identifier application number: NDA020411 ndc (package): 55566-2800-1 ndc (package): 55566-2800-0 ndc (product): 55566-2800 ndc11 (package): 55566280000 rxcui: 597959 rxcui: 597957 spl id: e99e60a2-51eb-417e-b2c4-67d5df479ea7 spl set id: f3bc9031-0620-4a50-b440-f661cadfeb1d unii: K7Q1JQR04M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.