Orphenadrine Citrate

Orange BookUNIISPLATC M03BC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNuCare Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeM03BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6626715820
20 TABLET, EXTENDED RELEASE in 1 BOTTLE (66267-158-20)
ndc11
6626715830
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (66267-158-30)

Annotations

UNII (FDA Substance ID)

X0A40N8I4S

ORPHENADRINE CITRATE

RxCUI 7716

Orange Book

A040284

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": "66267-158_1f93e675-f088-ddc1-e063-6294a90a42ba",
  "productndc": "66267-158",
  "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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