Prescription drug · NDA
Phexxi NDC 69751-100
lactic acid, l-, citric acid monohydrate, and potassium bitartrate · Lactic acid, L- 90 mg/5g + 2 more ingredients · Gel · Vaginal · Evofem, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69751-100-03 | 69751010003 | 3 APPLICATOR in 1 BOX (69751-100-03) / 5 g in 1 APPLICATOR (69751-100-01)Marketed from May 24, 2021 · Sample package | |
| 69751-100-12 | 69751010012 | 12 APPLICATOR in 1 BOX (69751-100-12) / 5 g in 1 APPLICATOR (69751-100-01)Marketed from Sep 1, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Phexxi
- Generic name (nonproprietary)
- lactic acid, l-, citric acid monohydrate, and potassium bitartrate
- Active ingredients
- Lactic acid, L- — 90 mg/5gCitric acid monohydrate — 50 mg/5gPotassium bitartrate — 20 mg/5g
- Dosage form
- Gel
- Route
- Vaginal
- Labeler
- Evofem, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208352
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 69751-100_11e3cfeb-3ae2-4e97-88f9-3e4cdf770659SPL ID 11e3cfeb-3ae2-4e97-88f9-3e4cdf770659SPL set ID 173ff411-7227-47b0-94dc-844e1ebaf14eRxCUI 2385348, 2385353UNII F9S9FFU82N, 2968PHW8QP, NPT6P8P3UU
- Pharmacologic class
- Anti-coagulant; Calculi Dissolution Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N469751010003followed by a unit qualifier and the quantityPackage 69751-0100-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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) ].
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208352
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Phexxlactic acid, l-, citric acid monohydrate, and potassium bitartrate | Lactic acid, L- 90 mg/5g + 2 more ingredients | GelVaginal | Evofem, Inc. | 69751-101 |