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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
- ndc11701211647710 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
Other records sharing ATC code J01AA12.
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