ROPIVACAINE HYDROCHLORIDE

In shortageOrange BookUNIISPLATC N01BB09

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

Identification

ManufacturerMylan Institutional LLC

CountryUS (United States)

ATC codeN01BB09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6745779899
10 POUCH in 1 CARTON (67457-798-99) / 1 BAG in 1 POUCH (67457-798-10) / 100 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

V910P86109

ROPIVACAINE HYDROCHLORIDE

RxCUI 1298851

Orange Book

A206091

APAP

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": "67457-798_78b68980-9e8d-4f38-ba2a-a9d520451f5d",
  "productndc": "67457-798",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "206091",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/100ML (2MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 26, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "400MG/200ML (2MG/ML)",
        "product_no": "002",
        "approval_date": "Oct 26, 2023"
      }
    ],
    "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": "ANDA206091",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ROPIVACAINE HYDROCHLORIDE",
  "start_marketing_date": "20240318",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N01BB09.

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