NDC codes

FDA NDC Directory
Product NDC (as listed)69751-100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69751-0100Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
69751-100-03697510100033 APPLICATOR in 1 BOX (69751-100-03) / 5 g in 1 APPLICATOR (69751-100-01)Marketed from May 24, 2021 · Sample package
69751-100-126975101001212 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
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

N469751010003 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 208352

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 208352
ProductStrengthForm · routeLabelerProduct NDC
Phexxlactic acid, l-, citric acid monohydrate, and potassium bitartrateLactic acid, L- 90 mg/5g + 2 more ingredientsGelVaginalEvofem, Inc.69751-101

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