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United States · US · US:63323-286_cdcd6c58-85cf-4d7e-9d97-b7c282a4f6b9
Naropin
In shortageOrange BookUNIISPLATC N01BB09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeN01BB09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc11633232860012 BOTTLE in 1 CASE (63323-286-00) / 100 mL in 1 BOTTLE (63323-286-03)
- ndc1163323286205 AMPULE in 1 BOX (63323-286-20) / 20 mL in 1 AMPULE (63323-286-01)
- ndc11633232862325 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-23) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-286-05)
- ndc1163323286301 VIAL, SINGLE-DOSE in 1 BOX (63323-286-30) / 30 mL in 1 VIAL, SINGLE-DOSE
- ndc1163323286315 VIAL, SINGLE-DOSE in 1 BOX (63323-286-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-09)
- ndc11633232863525 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-35) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-11)
- ndc11633232866312 BOTTLE in 1 CASE (63323-286-63) / 200 mL in 1 BOTTLE (63323-286-33)
Annotations
UNII (FDA Substance ID)
V910P86109
ROPIVACAINE HYDROCHLORIDE
RxCUI 1298851
Orange Book
N020533
APAPAPAPAPAPAPAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ropivacaine Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "V910P86109",
"rxcui": "1298851",
"inchikey": "VSHFRHVKMYGBJL-CKUXDGONSA-N",
"display_name": "ROPIVACAINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "EPIDURAL; INFILTRATION; PERINEURAL",
"spl_meta": {
"6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02": {
"match": "brand_token",
"title": "NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]",
"spl_version": "5",
"published_date": "2025-11-17"
}
},
"productid": "63323-286_cdcd6c58-85cf-4d7e-9d97-b7c282a4f6b9",
"productndc": "63323-286",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "020533",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "20MG/10ML (2MG/ML)",
"product_no": "001",
"approval_date": "May 1, 1998"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "40MG/20ML (2MG/ML)",
"product_no": "002",
"approval_date": "Sep 24, 1996"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "100MG/20ML (5MG/ML)",
"product_no": "003",
"approval_date": "May 1, 1998"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "150MG/20ML (7.5MG/ML)",
"product_no": "004",
"approval_date": "Sep 24, 1996"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "100MG/10ML (10MG/ML)",
"product_no": "005",
"approval_date": "Sep 24, 1996"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "200MG/100ML (2MG/ML)",
"product_no": "006",
"approval_date": "Sep 24, 1996"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "400MG/200ML (2MG/ML)",
"product_no": "007",
"approval_date": "Sep 24, 1996"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "150MG/30ML (5MG/ML)",
"product_no": "008",
"approval_date": "Sep 24, 1996"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "500MG/100ML (5MG/ML)",
"product_no": "009",
"approval_date": "Jan 4, 2011"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "1GM/200ML (5MG/ML)",
"product_no": "010",
"approval_date": "Jan 4, 2011"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "200MG/20ML (10MG/ML)",
"product_no": "011",
"approval_date": "Sep 24, 1996"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "012",
"approval_date": "Sep 24, 1996"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "013",
"approval_date": "May 1, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ROPIVACAINE HYDROCHLORIDE",
"shortage_reason": "Ropivacaine Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "Naropin",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020533",
"marketing_category": "NDA",
"nonproprietary_name": "ROPIVACAINE HYDROCHLORIDE",
"start_marketing_date": "19960924",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N01BB09.
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