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United States · US · US:0904-7577_1843fe79-7628-4f8e-9b51-e0be7562e43d
Megestrol Acetate
Orange BookUNIISPLATC L02AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeL02AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1109047577184 TRAY in 1 CASE (0904-7577-18) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7577-66)
- ndc11090475777210 TRAY in 1 CASE (0904-7577-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7577-66)
Annotations
UNII (FDA Substance ID)
TJ2M0FR8ES
MEGESTROL ACETATE
RxCUI 29451
Orange Book
A077404
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TJ2M0FR8ES",
"rxcui": "29451",
"inchikey": "RQZAXGRLVPAYTJ-GQFGMJRRSA-N",
"display_name": "MEGESTROL ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2dc921d5-e423-4379-a345-151e87d13651": {
"match": "brand_token",
"title": "MEGESTROL ACETATE SUSPENSION [UPSHER-SMITH LABORATORIES, LLC]",
"spl_version": "19",
"published_date": "2026-05-01"
}
},
"productid": "0904-7577_1843fe79-7628-4f8e-9b51-e0be7562e43d",
"productndc": "0904-7577",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "077404",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Feb 16, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MEGESTROL ACETATE",
"proprietary_name": "Megestrol Acetate",
"active_ingred_unit": "mg/10mL",
"application_number": "ANDA077404",
"marketing_category": "ANDA",
"nonproprietary_name": "Megestrol Acetate",
"start_marketing_date": "20251229",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code L02AB01.
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