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NDC 50261-0104-02 IMVEXXY 4 ug/1 Details
IMVEXXY 4 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 | 50261-0104 |
|---|---|
| Product ID | 50261-104_b33c36b2-f0a2-4525-a841-75c3ba011961 |
| Associated GPIs | 55350020009920 55350020009910 |
| GCN Sequence Number | 078478 |
| GCN Sequence Number Description | estradiol INSERT 4 MCG VAGINAL |
| HIC3 | Q4D |
| HIC3 Description | VAGINAL ESTROGEN FOR SEXUAL DYSFUNCTION |
| GCN | 44814 |
| 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 | 4 |
| 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 50261-0104-02 (50261010402)
| NDC Package Code | 50261-104-02 |
|---|---|
| Billing NDC | 50261010402 |
| Package | 1 BLISTER PACK in 1 CARTON (50261-104-02) / 2 INSERT in 1 BLISTER PACK |
| Marketing Start Date | 2018-08-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |