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United States · US · US:0781-3481_7eeef6bf-1bb2-42d7-9ee2-1a3865b9b11c

Tigecycline

Orange BookUNIISPLATC J01AA12

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeJ01AA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0781348192
    10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3481-92) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3481-70)

Annotations

UNII (FDA Substance ID)
70JE2N95KR
TIGECYCLINE
RxCUI 384455
Orange Book
A091620
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "70JE2N95KR",
    "rxcui": "384455",
    "inchikey": "FPZLLRFZJZRHSY-HJYUBDRYSA-N",
    "display_name": "TIGECYCLINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; PARENTERAL",
  "spl_meta": {
    "6e9a34af-8dee-4ba2-9157-2f5cb46958a9": {
      "match": "brand_token",
      "title": "TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]",
      "spl_version": "1",
      "published_date": "2026-04-02"
    }
  },
  "productid": "0781-3481_7eeef6bf-1bb2-42d7-9ee2-1a3865b9b11c",
  "productndc": "0781-3481",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "091620",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "May 27, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIGECYCLINE",
  "proprietary_name": "Tigecycline",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA091620",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tigecycline",
  "start_marketing_date": "20171130",
  "active_numerator_strength": "50"
}

Related drugs

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