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United States · US · US:25021-651_393d82d5-94f5-43fd-b5c8-d0554795233f

Orphenadrine Citrate

Orange BookUNIISPLATC M03BC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeM03BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2502165102
    10 VIAL in 1 CARTON (25021-651-02) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
X0A40N8I4S
ORPHENADRINE CITRATE
RxCUI 7716
Orange Book
A090585
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": "25021-651_393d82d5-94f5-43fd-b5c8-d0554795233f",
  "productndc": "25021-651",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "090585",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30MG/ML",
        "product_no": "001",
        "approval_date": "Aug 30, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ORPHENADRINE CITRATE",
  "proprietary_name": "Orphenadrine Citrate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090585",
  "marketing_category": "ANDA",
  "nonproprietary_name": "orphenadrine citrate",
  "start_marketing_date": "20111001",
  "active_numerator_strength": "30"
}

Related drugs

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