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United States · US · US:60505-6098_d4e75cae-c197-e995-7903-2d41c6c1371d

Tigecycline

Orange BookUNIISPLATC J01AA12

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

Identification

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

Packs · 1

  • ndc11
    6050560981
    10 VIAL, SINGLE-USE in 1 CARTON (60505-6098-1) / 5 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
70JE2N95KR
TIGECYCLINE
RxCUI 384455
Orange Book
A204439
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",
  "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": "60505-6098_d4e75cae-c197-e995-7903-2d41c6c1371d",
  "productndc": "60505-6098",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "204439",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 21, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIGECYCLINE",
  "proprietary_name": "Tigecycline",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA204439",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TIGECYCLINE",
  "start_marketing_date": "20190409",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code J01AA12.

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