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United States · US · US:69238-1290_e351b5e4-d97c-4b2b-8d12-ca34987d2b88
Beclomethasone Dipropionate
Orange BookUNIISPLATC R03BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeR03BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169238129041 CANISTER in 1 CARTON (69238-1290-4) / 120 AEROSOL, METERED in 1 CANISTER
Annotations
UNII (FDA Substance ID)
5B307S63B2
BECLOMETHASONE DIPROPIONATE
RxCUI 1348
Orange Book
A213811
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5B307S63B2",
"rxcui": "1348",
"inchikey": "KUVIULQEHSCUHY-XYWKZLDCSA-N",
"display_name": "BECLOMETHASONE DIPROPIONATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"d853c96f-21a3-4def-931d-4d47d16acd62": {
"match": "brand_token",
"title": "BECLOMETHASONE DIPROPIONATE AEROSOL, METERED [AMNEAL PHARMACEUTICALS NY LLC]",
"spl_version": "12",
"published_date": "2025-12-19"
}
},
"productid": "69238-1290_e351b5e4-d97c-4b2b-8d12-ca34987d2b88",
"productndc": "69238-1290",
"dosage_form": "AEROSOL, METERED",
"orange_book": {
"appl_no": "213811",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "0.04MG/INH",
"product_no": "001",
"approval_date": "Dec 16, 2025"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "0.08MG/INH",
"product_no": "002",
"approval_date": "Dec 16, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BECLOMETHASONE DIPROPIONATE",
"proprietary_name": "Beclomethasone Dipropionate",
"active_ingred_unit": "ug/1",
"application_number": "ANDA213811",
"marketing_category": "ANDA",
"nonproprietary_name": "Beclomethasone Dipropionate",
"start_marketing_date": "20251217",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code R03BA01.
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