Phexxi

Orange BookUNIISPLATC A09AB

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerEvofem, Inc.

CountryUS (United States)

ATC codeA09AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6975110003
3 APPLICATOR in 1 BOX (69751-100-03) / 5 g in 1 APPLICATOR (69751-100-01)
ndc11
6975110012
12 APPLICATOR in 1 BOX (69751-100-12) / 5 g in 1 APPLICATOR (69751-100-01)

Annotations

UNII (FDA Substance ID)

2968PHW8QP

CITRIC ACID MONOHYDRATE

RxCUI 221079

Orange Book

N208352

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2968PHW8QP",
    "rxcui": "221079",
    "inchikey": "YASYEJJMZJALEJ-UHFFFAOYSA-N",
    "display_name": "CITRIC ACID MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "173ff411-7227-47b0-94dc-844e1ebaf14e": {
      "match": "brand_token",
      "title": "PHEXXI (LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE) GEL [EVOFEM, INC.]",
      "spl_version": "7",
      "published_date": "2023-11-22"
    }
  },
  "productid": "69751-100_11e3cfeb-3ae2-4e97-88f9-3e4cdf770659",
  "productndc": "69751-100",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "208352",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1%;1.8%;0.4%",
        "product_no": "001",
        "approval_date": "May 22, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CITRIC ACID MONOHYDRATE; LACTIC ACID, L-; POTASSIUM BITARTRATE",
  "proprietary_name": "Phexxi",
  "active_ingred_unit": "mg/5g; mg/5g; mg/5g",
  "application_number": "NDA208352",
  "marketing_category": "NDA",
  "nonproprietary_name": "lactic acid, L-, citric acid monohydrate, and potassium bitartrate",
  "start_marketing_date": "20200801",
  "active_numerator_strength": "50; 90; 20"
}

Related drugs

Other records sharing ATC code A09AB.

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