lactic acid, L-, citric acid monohydrate, and potassium bitartrate
lactic acid, L-, citric acid monohydrate, and potassium bitartrate is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Phexxi, Phexx. Available dosage form: gel.
Drug Details
- Generic Name
- lactic acid, L-, citric acid monohydrate, and potassium bitartrate
- Brand Names
- Phexxi, Phexx
- Application Number
- NDA208352
- Sponsor
- Evofem, Inc.
- NDC Codes
- 2
- Dosage Forms
- GEL
- Routes
- VAGINAL
- Active Ingredients
- LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, POTASSIUM BITARTRATE
Indications and Usage
1 INDICATIONS AND USAGE PHEXXI is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. PHEXXI is a combination of lactic acid, citric acid, and potassium bitartrate indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. ( 1 ) Limitations of Use: PHEXXI is not effective for the prevention of pregnancy when administered after intercourse. Limitations of Use PHEXXI is not effective for the prevention of pregnancy when administered after intercourse [see Dosage and Administration (2.1) ].