FDA.reportPublic FDA data

Crinone

Product NDC
55056-0806
11-digit product format
550560806
Labeler code
55056
Product ID
55056-0806_f2c9bbef-22b9-413b-930d-e84fbea8247b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
progesterone
Dosage form
GEL
Route
VAGINAL
Labeler
Columbia Laboratories, Inc.
Application
NDA020701
Marketing category
NDA
Marketing start
1997-05-13
Marketing end
0000-00-00
Substance
PROGESTERONE
Active strength
90 mg/1.125g
Pharmacologic classes
Progesterone [CS],Progesterone [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55056-0806-22019-10-21C16284748780-1956f9ecf-bb83-621f-e053-dbdaa90a74adCrinone® 4% Crinone® 8% (progesterone gel)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55056-0806-2Crinone1.125 g in 1 APPLICATORGEL1.1252
55056-0806-2Crinone6 in 1 CARTONGEL62

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
progesteroneACTIVE INGREDIENT4G7DS2Q64YCRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.]2
progesteroneACTIVE MOIETY4G7DS2Q64YCRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.]2
carbomer 934INACTIVE INGREDIENTZ135WT9208CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXCRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPCRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.]2
palm oilINACTIVE INGREDIENT5QUO05548ZCRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.]2
polycarbophilINACTIVE INGREDIENTW25LM17A4WCRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.]2
sorbic acidINACTIVE INGREDIENTX045WJ989BCRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RCRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55056-0806CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.]2Legacy NDC, 2 package rows20091214_2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153579Crinone 4 % Vaginal GelPSN2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
153580Crinone 8 % Vaginal GelPSN2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
312643progesterone 4 % Vaginal GelPSN2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
312645progesterone 8 % Vaginal GelPSN2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
153579progesterone 0.04 MG/MG Vaginal Gel [Crinone]SBD2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
153580progesterone 0.08 MG/MG Vaginal Gel [Crinone]SBD2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
312643progesterone 0.04 MG/MG Vaginal GelSCD2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
312645progesterone 0.08 MG/MG Vaginal GelSCD2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
153579Crinone 0.04 MG/MG Vaginal GelSY2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
153580Crinone 0.08 MG/MG Vaginal GelSY2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
153579Crinone 4 % Vaginal GelSY2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
153580Crinone 8 % Vaginal GelSY2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
312643progesterone 4 % Vaginal GelSY2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62
312645progesterone 8 % Vaginal GelSY2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55056-0806-2550560806021.125 g in 1 APPLICATOR1.125 gHistorical