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United States · US · US:68462-711_732fcf7c-ebfa-4c6d-a06e-5e2ed8d90ef7
ESTRADIOL VAGINAL INSERTS
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168462711718 APPLICATOR in 1 CARTON (68462-711-71) / 1 TABLET, FILM COATED in 1 APPLICATOR
- ndc11684627118818 APPLICATOR in 1 CARTON (68462-711-88) / 1 TABLET, FILM COATED in 1 APPLICATOR
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A210264
AB
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": "VAGINAL",
"spl_meta": {
"50c786d6-91bd-4eea-9455-ff2abc08372f": {
"match": "brand_token",
"title": "ESTRADIOL AND NORETHINDRONE ACETATE TABLET [INGENUS PHARMACEUTICALS, LLC]",
"spl_version": "5",
"published_date": "2026-06-01"
}
},
"productid": "68462-711_732fcf7c-ebfa-4c6d-a06e-5e2ed8d90ef7",
"productndc": "68462-711",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210264",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MCG",
"product_no": "001",
"approval_date": "Sep 14, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "ESTRADIOL VAGINAL INSERTS",
"active_ingred_unit": "ug/1",
"application_number": "ANDA210264",
"marketing_category": "ANDA",
"nonproprietary_name": "estradiol",
"start_marketing_date": "20180917",
"active_numerator_strength": "10"
}Related drugs
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