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United States · US · US:70518-4506_508a41a9-403b-e409-e063-6294a90ad6fa
ORPHENADRINE CITRATE
Orange BookUNIISPLATC M03BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeM03BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11705184506014 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4506-0)
- ndc11705184506114 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4506-1)
- ndc11705184506250 POUCH in 1 BOX (70518-4506-2) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4506-3)
Annotations
UNII (FDA Substance ID)
X0A40N8I4S
ORPHENADRINE CITRATE
RxCUI 7716
Orange Book
A040284
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "X0A40N8I4S",
"rxcui": "7716",
"inchikey": "MMMNTDFSPSQXJP-UHFFFAOYSA-N",
"display_name": "ORPHENADRINE CITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7905e80f-b60b-48e8-8e63-a3e50211bfe4": {
"match": "brand_token",
"title": "ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]",
"spl_version": "3",
"published_date": "2026-04-30"
}
},
"productid": "70518-4506_508a41a9-403b-e409-e063-6294a90ad6fa",
"productndc": "70518-4506",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "040284",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jun 19, 1998"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ORPHENADRINE CITRATE",
"proprietary_name": "ORPHENADRINE CITRATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040284",
"marketing_category": "ANDA",
"nonproprietary_name": "ORPHENADRINE CITRATE",
"start_marketing_date": "20251015",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code M03BC01.
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