🇺🇸
United States · US · US:0121-0945_e4cbdf23-39ea-4f8e-b7b3-139b45d169f6
Megestrol Acetate
Orange BookUNIISPLATC L02AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeL02AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11012109450010 TRAY in 1 CASE (0121-0945-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0945-10)
- ndc1101210945404 TRAY in 1 CASE (0121-0945-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0945-10)
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": "0121-0945_e4cbdf23-39ea-4f8e-b7b3-139b45d169f6",
"productndc": "0121-0945",
"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/10mL",
"application_number": "ANDA075671",
"marketing_category": "ANDA",
"nonproprietary_name": "Megestrol Acetate",
"start_marketing_date": "20010725",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code L02AB01.
Access this data programmatically
Query Megestrol Acetate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.