ZYNRELEF

Orange BookUNIISPLATC N01BB

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

Identification

ManufacturerHeron Therapeutics, Inc.

CountryUS (United States)

ATC codeN01BB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4742650301
1 CARTON in 1 KIT (47426-503-01) / 1 VIAL, SINGLE-DOSE in 1 CARTON (47426-503-03) / 2.3 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

Y8335394RO

BUPIVACAINE

RxCUI 1815

Orange Book

N211988

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "Y8335394RO",
    "rxcui": "1815",
    "inchikey": "LEBVLXFERQHONN-UHFFFAOYSA-N",
    "display_name": "BUPIVACAINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INFILTRATION",
  "spl_meta": {
    "dab484a7-9353-43ba-9e74-7fab910c712b": {
      "match": "brand_token",
      "title": "ZYNRELEF (BUPIVACAINE AND MELOXICAM) SOLUTION [HERON THERAPEUTICS, INC.]",
      "spl_version": "16",
      "published_date": "2026-04-30"
    }
  },
  "productid": "47426-503_ab2a0921-41d7-4b3b-ace9-6adccb12c5e9",
  "productndc": "47426-503",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "211988",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)",
        "product_no": "001",
        "approval_date": "May 12, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)",
        "product_no": "002",
        "approval_date": "May 12, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)",
        "product_no": "003",
        "approval_date": "May 12, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)",
        "product_no": "004",
        "approval_date": "May 12, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPIVACAINE; MELOXICAM",
  "proprietary_name": "ZYNRELEF",
  "active_ingred_unit": "mg/7mL; mg/7mL",
  "application_number": "NDA211988",
  "marketing_category": "NDA",
  "nonproprietary_name": "BUPIVACAINE and MELOXICAM",
  "start_marketing_date": "20241201",
  "active_numerator_strength": "200; 6"
}

Related drugs

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