DIVIGEL

Orange BookUNIISPLATC G03CA03

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

Identification

ManufacturerVertical Pharmaceuticals, LLC

CountryUS (United States)

ATC codeG03CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6802508607
7 PACKET in 1 CARTON (68025-086-07) / 1.25 g in 1 PACKET
ndc11
6802508630
30 PACKET in 1 CARTON (68025-086-30) / 1.25 g in 1 PACKET

Annotations

UNII (FDA Substance ID)

4TI98Z838E

ESTRADIOL

RxCUI 4083

Orange Book

N022038

ABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4TI98Z838E",
    "rxcui": "4083",
    "inchikey": "VOXZDWNPVJITMN-ZBRFXRBCSA-N",
    "display_name": "ESTRADIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "59e610dc-883e-4f07-9ec6-a5841b0bf9fb": {
      "match": "brand_token",
      "title": "DIVIGEL (ESTRADIOL) GEL [VERTICAL PHARMACEUTICALS, LLC]",
      "spl_version": "31",
      "published_date": "2026-03-05"
    }
  },
  "productid": "68025-086_077120b4-1172-49bc-b197-363f410589ab",
  "productndc": "68025-086",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "022038",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1% (0.25GM/PACKET)",
        "product_no": "001",
        "approval_date": "Jun 4, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1% (0.5GM/PACKET)",
        "product_no": "002",
        "approval_date": "Jun 4, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1% (1GM/PACKET)",
        "product_no": "003",
        "approval_date": "Jun 4, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1% (0.75GM/PACKET)",
        "product_no": "004",
        "approval_date": "Aug 17, 2018"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.1% (1.25GM/PACKET)",
        "product_no": "005",
        "approval_date": "Dec 12, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL",
  "proprietary_name": "DIVIGEL",
  "active_ingred_unit": "mg/1.25g",
  "application_number": "NDA022038",
  "marketing_category": "NDA",
  "nonproprietary_name": "estradiol",
  "start_marketing_date": "20191217",
  "active_numerator_strength": "1.25"
}

Related drugs

Other records sharing ATC code G03CA03.

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