🇺🇸
United States · US · US:66220-315_7664f8a4-33c4-4f30-998e-86333640c44d
VIBATIV
Orange BookUNIISPLATC J01XA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCumberland Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01XA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1166220315111 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-11) / 50 mL in 1 VIAL, SINGLE-DOSE
- ndc11662203152212 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-22) / 50 mL in 1 VIAL, SINGLE-DOSE
- ndc1166220315444 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-44) / 50 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
0701472ZG0
TELAVANCIN HYDROCHLORIDE
RxCUI 864624
Orange Book
N022110
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0701472ZG0",
"rxcui": "864624",
"inchikey": "GSSIWSIRBWAZHG-ACOPVEIWSA-N",
"display_name": "TELAVANCIN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"5359b759-db7c-4672-9e8a-59c93869bd91": {
"match": "brand_token",
"title": "VIBATIV (TELAVANCIN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]",
"spl_version": "6",
"published_date": "2025-12-23"
}
},
"productid": "66220-315_7664f8a4-33c4-4f30-998e-86333640c44d",
"productndc": "66220-315",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "022110",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 250MG BASE/VIAL",
"product_no": "001",
"approval_date": "Sep 11, 2009"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 750MG BASE/VIAL",
"product_no": "002",
"approval_date": "Sep 11, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TELAVANCIN HYDROCHLORIDE",
"proprietary_name": "VIBATIV",
"active_ingred_unit": "mg/mL",
"application_number": "NDA022110",
"marketing_category": "NDA",
"nonproprietary_name": "telavancin hydrochloride",
"start_marketing_date": "20210101",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code J01XA03.
Access this data programmatically
Query VIBATIV and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.