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United States · US · US:63629-1564_1a6afbdf-cba9-4ed0-9d82-1f47fb32dd7a

Orphenadrine Citrate

Orange BookUNIISPLATC M03BC01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM03BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    6362915640
    56 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-0)
  • ndc11
    6362915641
    20 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-1)
  • ndc11
    6362915642
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-2)
  • ndc11
    6362915643
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-3)
  • ndc11
    6362915644
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-4)
  • ndc11
    6362915645
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-5)
  • ndc11
    6362915646
    28 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-6)
  • ndc11
    6362915647
    45 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-7)
  • ndc11
    6362915648
    14 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-8)
  • ndc11
    6362915649
    120 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-9)

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": "63629-1564_1a6afbdf-cba9-4ed0-9d82-1f47fb32dd7a",
  "productndc": "63629-1564",
  "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

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