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United States · US · US:0115-1911_b5f5cd6c-3874-4507-bbd4-72e8c5bfe17f

Rimantadine Hydrochloride

Orange BookUNIISPLATC J05AC02

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeJ05AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0115191101
    100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01)
  • ndc11
    0115191102
    500 TABLET, FILM COATED in 1 BOTTLE (0115-1911-02)

Annotations

UNII (FDA Substance ID)
JEI07OOS8Y
RIMANTADINE HYDROCHLORIDE
RxCUI 82093
Orange Book
A076132
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "JEI07OOS8Y",
    "rxcui": "82093",
    "inchikey": "OZBDFBJXRJWNAV-UHFFFAOYSA-N",
    "display_name": "RIMANTADINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "49f7d69a-820b-4c75-a31d-b2104c019c12": {
      "match": "brand_token",
      "title": "RIMANTADINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
      "spl_version": "10",
      "published_date": "2024-01-01"
    }
  },
  "productid": "0115-1911_b5f5cd6c-3874-4507-bbd4-72e8c5bfe17f",
  "productndc": "0115-1911",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076132",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 30, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RIMANTADINE HYDROCHLORIDE",
  "proprietary_name": "Rimantadine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076132",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rimantadine Hydrochloride",
  "start_marketing_date": "20211116",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code J05AC02.

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