ropivacaine hydrochloride

In shortageOrange BookUNIISPLATC N01BB09

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

Identification

ManufacturerSagent Pharmaceuticals

CountryUS (United States)

ATC codeN01BB09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
2502167182
10 BAG in 1 CARTON (25021-671-82) / 100 mL in 1 BAG
ndc11
2502167187
10 BAG in 1 CARTON (25021-671-87) / 200 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

V910P86109

ROPIVACAINE HYDROCHLORIDE

RxCUI 1298851

Orange Book

A206166

APAPAPAP

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",
  "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": "25021-671_41f4446a-ca6e-465e-9a79-8c4f99eb1ac3",
  "productndc": "25021-671",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "206166",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/100ML (2MG/ML)",
        "product_no": "001",
        "approval_date": "Jun 11, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "400MG/200ML (2MG/ML)",
        "product_no": "002",
        "approval_date": "Jun 11, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/100ML (5MG/ML)",
        "product_no": "003",
        "approval_date": "Jun 11, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/200ML (5MG/ML)",
        "product_no": "004",
        "approval_date": "Jun 11, 2018"
      }
    ],
    "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": "ANDA206166",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ropivacaine hydrochloride",
  "start_marketing_date": "20181215",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N01BB09.

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