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United States · US · US:69339-160_2de58bb1-eff3-471a-8760-7006d7c54030
Megestrol Acetate
Orange BookUNIISPLATC L02AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNatco Pharma USA LLC
CountryUS (United States)
ATC codeL02AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1169339160163 TRAY in 1 CASE (69339-160-16) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-160-01)
- ndc1169339160174 TRAY in 1 CASE (69339-160-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-160-01)
- ndc1169339160185 TRAY in 1 CASE (69339-160-18) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-160-01)
- ndc11693391601910 TRAY in 1 CASE (69339-160-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-160-01)
Annotations
UNII (FDA Substance ID)
TJ2M0FR8ES
MEGESTROL ACETATE
RxCUI 29451
Orange Book
A075671
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": "69339-160_2de58bb1-eff3-471a-8760-7006d7c54030",
"productndc": "69339-160",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "075671",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Jul 25, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MEGESTROL ACETATE",
"proprietary_name": "Megestrol Acetate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA075671",
"marketing_category": "ANDA",
"nonproprietary_name": "Megestrol Acetate",
"start_marketing_date": "20230731",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code L02AB01.
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