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United States · US · US:0008-4990_471458bc-2d5f-470b-a6a4-f4bf0eacf95b

Tygacil

Orange BookUNIISPLATC J01AA12

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

Identification

ManufacturerWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
CountryUS (United States)
ATC codeJ01AA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0008499020
    10 VIAL, SINGLE-DOSE in 1 CARTON (0008-4990-20) / 5 mL in 1 VIAL, SINGLE-DOSE (0008-4990-19)

Annotations

UNII (FDA Substance ID)
70JE2N95KR
TIGECYCLINE
RxCUI 384455
Orange Book
N021821
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": {
    "fd826e47-1b77-4ffd-bb22-fda3379903b0": {
      "match": "brand_token",
      "title": "TYGACIL (TIGECYCLINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]",
      "spl_version": "15",
      "published_date": "2025-11-19"
    }
  },
  "productid": "0008-4990_471458bc-2d5f-470b-a6a4-f4bf0eacf95b",
  "productndc": "0008-4990",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "021821",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "50MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 15, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIGECYCLINE",
  "proprietary_name": "Tygacil",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA021821",
  "marketing_category": "NDA",
  "nonproprietary_name": "TIGECYCLINE",
  "start_marketing_date": "20080615",
  "active_numerator_strength": "50"
}

Related drugs

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