Treprostinil

Orange BookUNIISPLATC B01AC21

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

Identification

ManufacturerDr.Reddy's Laboratories Inc.,

CountryUS (United States)

ATC codeB01AC21

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359864611
1 VIAL in 1 CARTON (43598-646-11) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

RUM6K67ESG

TREPROSTINIL

RxCUI 343048

Orange Book

A210214

APAPAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "RUM6K67ESG",
    "rxcui": "343048",
    "inchikey": "PAJMKGZZBBTTOY-ZFORQUDYSA-N",
    "display_name": "TREPROSTINIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "4a684b13-669d-4721-8ed4-30cc7762b0b8": {
      "match": "brand_token",
      "title": "TREPROSTINIL INJECTION, SOLUTION [ALEMBIC PHARMACEUTICALS INC.]",
      "spl_version": "8",
      "published_date": "2025-03-13"
    }
  },
  "productid": "43598-646_61347918-bb33-236c-6a2e-280b59e7ab31",
  "productndc": "43598-646",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210214",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "May 22, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "2.5MG/ML",
        "product_no": "002",
        "approval_date": "May 22, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/ML",
        "product_no": "003",
        "approval_date": "May 22, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "004",
        "approval_date": "May 22, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TREPROSTINIL",
  "proprietary_name": "Treprostinil",
  "active_ingred_unit": "mg/20mL",
  "application_number": "ANDA210214",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Treprostinil",
  "start_marketing_date": "20230213",
  "active_numerator_strength": "50"
}

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