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United States · US · US:55150-228_a5262444-a326-478c-a6d6-b515ef3d1219

Tigecycline

Orange BookUNIISPLATC J01AA12

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

Identification

ManufacturerEugia US LLC
CountryUS (United States)
ATC codeJ01AA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515022810
    10 VIAL, SINGLE-DOSE in 1 CARTON (55150-228-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
70JE2N95KR
TIGECYCLINE
RxCUI 384455
Orange Book
A206335
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": "55150-228_a5262444-a326-478c-a6d6-b515ef3d1219",
  "productndc": "55150-228",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "206335",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 11, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIGECYCLINE",
  "proprietary_name": "Tigecycline",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206335",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tigecycline",
  "start_marketing_date": "20190611",
  "active_numerator_strength": "50"
}

Related drugs

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