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NDC 50261-0110-02 IMVEXXY 10 ug/1 Details
IMVEXXY 10 ug/1
IMVEXXY is a VAGINAL INSERT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mayne Pharma LLC. The primary component is ESTRADIOL.
Product Information
NDC | 50261-0110 |
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Product ID | 50261-110_b33c36b2-f0a2-4525-a841-75c3ba011961 |
Associated GPIs | 55350020009940 55350020009930 |
GCN Sequence Number | 078477 |
GCN Sequence Number Description | estradiol INSERT 10 MCG VAGINAL |
HIC3 | Q4D |
HIC3 Description | VAGINAL ESTROGEN FOR SEXUAL DYSFUNCTION |
GCN | 44813 |
HICL Sequence Number | 001421 |
HICL Sequence Number Description | ESTRADIOL |
Brand/Generic | Brand |
Proprietary Name | IMVEXXY |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | estradiol |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INSERT |
Route | VAGINAL |
Active Ingredient Strength | 10 |
Active Ingredient Units | ug/1 |
Substance Name | ESTRADIOL |
Labeler Name | Mayne Pharma LLC |
Pharmaceutical Class | Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC] |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA208564 |
Listing Certified Through | 2024-12-31 |
Package
NDC 50261-0110-02 (50261011002)
NDC Package Code | 50261-110-02 |
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Billing NDC | 50261011002 |
Package | 1 BLISTER PACK in 1 CARTON (50261-110-02) / 2 INSERT in 1 BLISTER PACK |
Marketing Start Date | 2018-07-09 |
NDC Exclude Flag | N |
Pricing Information | N/A |