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United States · US · US:0641-6182_dde13b7f-78fb-4b9a-bc16-a41bf45042be
Orphenadrine citrate
Orange BookUNIISPLATC M03BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeM03BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11064161822525 BOX in 1 BOX (0641-6182-25) / 10 VIAL in 1 BOX (0641-6182-10) / 2 mL in 1 VIAL (0641-6182-01)
Annotations
UNII (FDA Substance ID)
X0A40N8I4S
ORPHENADRINE CITRATE
RxCUI 7716
Orange Book
A040463
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
"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": "0641-6182_dde13b7f-78fb-4b9a-bc16-a41bf45042be",
"productndc": "0641-6182",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "040463",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "30MG/ML",
"product_no": "001",
"approval_date": "Mar 4, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ORPHENADRINE CITRATE",
"proprietary_name": "Orphenadrine citrate",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA040463",
"marketing_category": "ANDA",
"nonproprietary_name": "Orphenadrine citrate",
"start_marketing_date": "20030428",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code M03BC01.
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