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United States · US · US:43063-407_47d2a4d7-5572-e023-e063-6394a90a3617
ORPHENADRINE CITRATE
Orange BookUNIISPLATC M03BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeM03BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11430634071414 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-14)
- ndc11430634072020 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-20)
- ndc11430634073030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-30)
- ndc11430634076060 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-407-60)
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": "43063-407_47d2a4d7-5572-e023-e063-6394a90a3617",
"productndc": "43063-407",
"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": "19980619",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code M03BC01.
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