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United States · US · US:70518-4594_4dc43e85-741c-b323-e063-6394a90a0d75

Rifabutin

Orange BookUNIISPLATC J04AB04

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ04AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051845940
    60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4594-0)

Annotations

UNII (FDA Substance ID)
1W306TDA6S
RIFABUTIN
RxCUI 55672
Orange Book
A215041
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1W306TDA6S",
    "rxcui": "55672",
    "inchikey": "ATEBXHFBFRCZMA-VXTBVIBXSA-N",
    "display_name": "RIFABUTIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "10fb5949-5572-47bd-aaf0-018d9978cad8": {
      "match": "brand_token",
      "title": "RIFABUTIN CAPSULE [A2A INTEGRATED PHARMACEUTICALS]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70518-4594_4dc43e85-741c-b323-e063-6394a90a0d75",
  "productndc": "70518-4594",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "215041",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Dec 17, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RIFABUTIN",
  "proprietary_name": "Rifabutin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215041",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rifabutin",
  "start_marketing_date": "20260324",
  "active_numerator_strength": "150"
}

Related drugs

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