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NDC 69751-0100-12 Phexxi 50; 90; 20 mg/5g; mg/5g; mg/5g Details
Phexxi 50; 90; 20 mg/5g; mg/5g; mg/5g
Phexxi is a VAGINAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Evofem, Inc.. The primary component is CITRIC ACID MONOHYDRATE; LACTIC ACID, L-; POTASSIUM BITARTRATE.
MedlinePlus Drug Summary
The combination of lactic acid, citric acid, and potassium bitartrate is used to prevent pregnancy when used just before vaginal sex in women who can become pregnant. It does not prevent pregnancy when used after vaginal sex. The combination of lactic acid, citric acid, and potassium bitartrate is in a class of medications called non-hormonal contraceptives. It works by lowering the pH of the vagina and reducing sperm motility. Lactic acid, citric acid, and potassium bitartrate may prevent pregnancy, but this medication will not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
Related Packages: 69751-0100-12Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lactic Acid, Citric Acid, and Potassium Bitartrate Vaginal Contraceptive
Product Information
| NDC | 69751-0100 |
|---|---|
| Product ID | 69751-100_11e3cfeb-3ae2-4e97-88f9-3e4cdf770659 |
| Associated GPIs | 55329903404020 |
| GCN Sequence Number | 081105 |
| GCN Sequence Number Description | lactic acid/citric/potassium GEL/PF APP 1.8-1-0.4% VAGINAL |
| HIC3 | G9A |
| HIC3 Description | CONTRACEPTIVES,INTRAVAGINAL |
| GCN | 48142 |
| HICL Sequence Number | 046568 |
| HICL Sequence Number Description | LACTIC ACID/CITRIC ACID/POTASSIUM BITARTRATE |
| Brand/Generic | Brand |
| Proprietary Name | Phexxi |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | lactic acid, L-, citric acid monohydrate, and potassium bitartrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GEL |
| Route | VAGINAL |
| Active Ingredient Strength | 50; 90; 20 |
| Active Ingredient Units | mg/5g; mg/5g; mg/5g |
| Substance Name | CITRIC ACID MONOHYDRATE; LACTIC ACID, L-; POTASSIUM BITARTRATE |
| Labeler Name | Evofem, Inc. |
| Pharmaceutical Class | Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208352 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69751-0100-12 (69751010012)
| NDC Package Code | 69751-100-12 |
|---|---|
| Billing NDC | 69751010012 |
| Package | 12 APPLICATOR in 1 BOX (69751-100-12) / 5 g in 1 APPLICATOR (69751-100-01) |
| Marketing Start Date | 2020-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 5.56494 |
| Pricing Unit | GM |
| Effective Date | 2024-01-01 |
| NDC Description | PHEXXI 1.8-1-0.4% VAGINAL GEL |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |