Progesterone vaginal insert

Product NDC
70700-201
11-digit product format
707000201
Labeler code
70700
Product ID
70700-201_5264f1f1-0a2d-1506-22f5-71074729ece9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
INSERT
Route
VAGINAL
Labeler
XIROMED, LLC
Application
ANDA218391
Marketing category
ANDA
Marketing start
2025-09-23
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
Progesterone vaginal insert
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROGESTERONE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4G7DS2Q64Y
Rxcui725094

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
70700-201-68Progesterone vaginal insert1 in 1 BLISTER PACKINSERT14
70700-201-69Progesterone vaginal insert21 in 1 CARTONINSERT214
70700-201-70Progesterone vaginal insert1 in 1 CARTONINSERT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-201-70EA - Each70700-20193e6f9b6-81c0-4357-abe5-6565c245608c12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
725094progesterone 100 MG Vaginal TabletPSN473ab609-5b9e-3cb8-68d5-4a459a2ea6c14
725094progesterone 100 MG Vaginal InsertSCD473ab609-5b9e-3cb8-68d5-4a459a2ea6c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70700-201-68707000201681 in 1 BLISTER PACKHistorical
70700-201-697070002016921 in 1 CARTONHistorical
70700-201-70707000201701 CARTON in 1 CARTON (70700-201-70) / 21 BLISTER PACK in 1 CARTON (70700-201-69) / 1 INSERT in 1 BLISTER PACK (70700-201-68) 1 carton2025-09-23NoNoHistorical