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United States · US · US:70121-1647_c21de58f-dcd0-46f7-a6d9-0ff5ba5863a1

Tigecycline

Orange BookUNIISPLATC J01AA12

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

Identification

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

Packs · 1

  • ndc11
    7012116477
    10 VIAL in 1 CARTON (70121-1647-7) / 5 mL in 1 VIAL (70121-1647-1)

Annotations

UNII (FDA Substance ID)
70JE2N95KR
TIGECYCLINE
RxCUI 384455
Orange Book
N211158
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": "70121-1647_c21de58f-dcd0-46f7-a6d9-0ff5ba5863a1",
  "productndc": "70121-1647",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "211158",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Aug 2, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIGECYCLINE",
  "proprietary_name": "Tigecycline",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA211158",
  "marketing_category": "NDA",
  "nonproprietary_name": "Tigecycline",
  "start_marketing_date": "20180131",
  "active_numerator_strength": "50"
}

Related drugs

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