FDA.reportPublic FDA data

CERVIDIL

Product NDC
55566-2800
11-digit product format
555662800
Labeler code
55566
Product ID
55566-2800_e99e60a2-51eb-417e-b2c4-67d5df479ea7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DINOPROSTONE
Dosage form
INSERT
Route
VAGINAL
Labeler
Ferring Pharmaceuticals Inc.
Application
NDA020411
Marketing category
NDA
Marketing start
1995-03-30
Substance
DINOPROSTONE
Active strength
10 mg/241mg
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DINOPROSTONE10 mg/241mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK7Q1JQR04M
Rxcui597957, 597959

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec05fe7c-3d4a-04dc-e557-6592b22322f9Product name120150831
66f853e1-4ba2-ac23-4f5d-e914cffa20b6Product name120150828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55566-2800-0CERVIDIL10 mg in 1 POUCHINSERT1010
55566-2800-1CERVIDIL1 in 1 CARTONINSERT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55566-2800-1EA - Each55566-280032d9ee4b-22fb-4ebe-b05b-6868d45ffa8a12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DINOPROSTONEACTIVE INGREDIENTK7Q1JQR04MCERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]2
DINOPROSTONEACTIVE MOIETYK7Q1JQR04MCERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55566-2800CERVIDIL (DINOPROSTONE) INSERT [FERRING PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 2 package rows20230607_f3bc9031-0620-4a50-b440-f661cadfeb1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597959Cervidil 10 MG Vaginal InsertPSNf3bc9031-0620-4a50-b440-f661cadfeb1d10
597957dinoprostone 10 MG Vaginal InsertPSNf3bc9031-0620-4a50-b440-f661cadfeb1d10
597959dinoprostone 10 MG Vaginal Insert [Cervidil]SBDf3bc9031-0620-4a50-b440-f661cadfeb1d10
597957dinoprostone 10 MG Vaginal InsertSCDf3bc9031-0620-4a50-b440-f661cadfeb1d10
597959Cervidil 10 MG Drug ImplantSYf3bc9031-0620-4a50-b440-f661cadfeb1d10
597959Cervidil 10 MG Vaginal InsertSYf3bc9031-0620-4a50-b440-f661cadfeb1d10
597957PGE2 10 MG Vaginal InsertSYf3bc9031-0620-4a50-b440-f661cadfeb1d10
597959PGE2 10 MG Vaginal Insert [Cervidil]SYf3bc9031-0620-4a50-b440-f661cadfeb1d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55566-2800-05556628000010 mg in 1 POUCH10 mgHistorical
55566-2800-1555662800011 POUCH in 1 CARTON (55566-2800-1) / 10 mg in 1 POUCH (55566-2800-0) 1 pouch1995-03-300000-00-00NoNoCurrent