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United States · US · US:0548-5701_8ef1da8b-5fce-4375-9186-39f75adc4f1b
Medroxyprogesterone Acetate
Orange BookUNIISPLATC L02AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmphastar Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL02AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105485701001 SYRINGE in 1 CARTON (0548-5701-00) / 1 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
C2QI4IOI2G
MEDROXYPROGESTERONE ACETATE
RxCUI 1000112
Orange Book
A077334
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "C2QI4IOI2G",
"rxcui": "1000112",
"inchikey": "PSGAAPLEWMOORI-PEINSRQWSA-N",
"display_name": "MEDROXYPROGESTERONE ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR",
"spl_meta": {
"1020bb60-4f13-4cd7-aaa1-c556752c84b7": {
"match": "brand_token",
"title": "MEDROXYPROGESTERONE ACETATE TABLET [REMEDYREPACK INC.]",
"spl_version": "1",
"published_date": "2026-05-28"
}
},
"productid": "0548-5701_8ef1da8b-5fce-4375-9186-39f75adc4f1b",
"productndc": "0548-5701",
"dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"orange_book": {
"appl_no": "077334",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG/ML",
"product_no": "001",
"approval_date": "Nov 28, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MEDROXYPROGESTERONE ACETATE",
"proprietary_name": "Medroxyprogesterone Acetate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA077334",
"marketing_category": "ANDA",
"nonproprietary_name": "Medroxyprogesterone acetate",
"start_marketing_date": "20171128",
"active_numerator_strength": "150"
}Related drugs
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