FDA.reportPublic FDA data

ENDOMETRIN

Product NDC
55566-6500
11-digit product format
555666500
Labeler code
55566
Product ID
55566-6500_036428ab-ccb8-450f-8509-ccea24452cd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
INSERT
Route
VAGINAL
Labeler
Ferring Pharmaceuticals Inc.
Application
NDA022057
Marketing category
NDA
Marketing start
2007-06-21
Substance
PROGESTERONE
Active strength
100 mg/1
Pharmacologic classes
Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ENDOMETRIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROGESTERONE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4G7DS2Q64Y
Rxcui725094, 725098

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55566-6500-1ENDOMETRIN1 in 1 BLISTER PACKINSERT124
55566-6500-2ENDOMETRIN21 in 1 CARTONINSERT2124
55566-6500-3ENDOMETRIN1 in 1 CARTONINSERT124
55566-6500-4ENDOMETRIN21 in 1 BLISTER PACKINSERT2124
55566-6500-7ENDOMETRIN21 in 1 CARTONINSERT2124
55566-6500-8ENDOMETRIN21 in 1 CARTONINSERT2124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55566-6500-1EA - Each55566-6500d5bfa955-c304-4c23-8343-ff0c538da2de12014-05-02
55566-6500-2EA - Each55566-65004275c563-b289-4c4b-aa34-20bf2af11a1e12012-07-24
55566-6500-3EA - Each55566-6500be904677-f734-410c-bfa1-9b3abdc2846912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ProgesteroneACTIVE INGREDIENT4G7DS2Q64YENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]11
ProgesteroneACTIVE MOIETY4G7DS2Q64YENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]11
Adipic AcidINACTIVE INGREDIENT76A0JE0FKJENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]11
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]11
Magnesium StearateINACTIVE INGREDIENT70097M6I30ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]11
Povidone K29/32INACTIVE INGREDIENT390RMW2PEQENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]11
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]11
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QOENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]11
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]11
Starch, CornINACTIVE INGREDIENTO8232NY3SJENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55566-6500ENDOMETRIN (PROGESTERONE) INSERT [FERRING PHARMACEUTICALS INC.]21Current NDC, Legacy NDC, 6 package rows20250410_2ba50fa9-b349-40cb-9a4b-1af8faa4ec09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
725098Endometrin 100 MG Vaginal InsertPSN2ba50fa9-b349-40cb-9a4b-1af8faa4ec0924
725094progesterone 100 MG Vaginal TabletPSN2ba50fa9-b349-40cb-9a4b-1af8faa4ec0924
725098progesterone 100 MG Vaginal Insert [Endometrin]SBD2ba50fa9-b349-40cb-9a4b-1af8faa4ec0924
725094progesterone 100 MG Vaginal InsertSCD2ba50fa9-b349-40cb-9a4b-1af8faa4ec0924
725098Endometrin 100 MG Vaginal InsertSY2ba50fa9-b349-40cb-9a4b-1af8faa4ec0924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55566-6500-1555666500011 in 1 BLISTER PACKHistorical
55566-6500-25556665000221 in 1 CARTONHistorical
55566-6500-3555666500031 CARTON in 1 CARTON (55566-6500-3) / 21 BLISTER PACK in 1 CARTON (55566-6500-2) / 1 INSERT in 1 BLISTER PACK (55566-6500-1) 1 carton2007-06-210000-00-00NoNoCurrent
55566-6500-45556665000421 in 1 BLISTER PACKHistorical
55566-6500-75556665000721 in 1 CARTONHistorical
55566-6500-85556665000821 CARTON in 1 CARTON (55566-6500-8) / 21 BLISTER PACK in 1 CARTON (55566-6500-7) / 21 INSERT in 1 BLISTER PACK (55566-6500-4) 21 carton2007-06-21YesNoHistorical