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United States · US · US:71288-019_944a7489-75b7-4841-a189-1bb66fa83e30

Tigecycline

Orange BookUNIISPLATC J01AA12

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

Identification

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

Packs · 1

  • ndc11
    7128801911
    10 VIAL, SINGLE-DOSE in 1 CARTON (71288-019-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-019-10)

Annotations

UNII (FDA Substance ID)
70JE2N95KR
TIGECYCLINE
RxCUI 384455
Orange Book
A214020
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": "71288-019_944a7489-75b7-4841-a189-1bb66fa83e30",
  "productndc": "71288-019",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214020",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "May 13, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIGECYCLINE",
  "proprietary_name": "Tigecycline",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA214020",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tigecycline",
  "start_marketing_date": "20210513",
  "active_numerator_strength": "50"
}

Related drugs

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