Ropivacaine Hydrochloride

In shortageOrange BookUNIISPLATC N01BB09

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSportpharm LLC

CountryUS (United States)

ATC codeN01BB09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8576609801
1 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-01) / 30 mL in 1 VIAL, SINGLE-DOSE
ndc11
8576609825
25 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-25) / 30 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

V910P86109

ROPIVACAINE HYDROCHLORIDE

RxCUI 1298851

Orange Book

A205612

APAPAPAPAPAPAP

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": {
    "3849f5ce-d077-4318-935d-294be6948142": {
      "match": "brand_token",
      "title": "ROPIVACAINE HYDROCHLORIDE INJECTION [ARMAS PHARMACEUTICALS INC.]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "85766-098_503911bf-380c-d5f2-e063-6294a90ac760",
  "productndc": "85766-098",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "205612",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MG/20ML (2MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/100ML (2MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/20ML (5MG/ML)",
        "product_no": "003",
        "approval_date": "Jul 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "150MG/30ML (5MG/ML)",
        "product_no": "004",
        "approval_date": "Jul 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "150MG/20ML (7.5MG/ML)",
        "product_no": "005",
        "approval_date": "Jul 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/10ML (10MG/ML)",
        "product_no": "006",
        "approval_date": "Jul 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/20ML (10MG/ML)",
        "product_no": "007",
        "approval_date": "Jul 13, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROPIVACAINE HYDROCHLORIDE",
  "shortage_reason": "Ropivacaine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Ropivacaine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA205612",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ropivacaine Hydrochloride",
  "start_marketing_date": "20160915",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N01BB09.

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