Orphenadrine Citrate

Orange BookUNIISPLATC M03BC01

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

Identification

ManufacturerPreferred Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeM03BC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6878891381
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-1)
ndc11
6878891382
20 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-2)
ndc11
6878891383
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-3)
ndc11
6878891384
14 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-4)
ndc11
6878891386
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-6)
ndc11
6878891388
120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-8)
ndc11
6878891389
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-9138-9)

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": "68788-9138_0352ec7a-81c3-46fb-a72d-3283c64acec8",
  "productndc": "68788-9138",
  "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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