Sterile Diluent for Treprostinil

Orange BookUNIISPL

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

Identification

ManufacturerDr.Reddy's Laboratories Inc.,

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359812611
1 VIAL in 1 CARTON (43598-126-11) / 50 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

059QF0KO0R

WATER

RxCUI 11295

Orange Book

A210214

APAPAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "059QF0KO0R",
    "rxcui": "11295",
    "inchikey": "XLYOFNOQVPJJNP-UHFFFAOYSA-N",
    "display_name": "WATER",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "39df5fc7-f66e-1605-e063-6394a90a0054": {
      "match": "brand_token",
      "title": "STERILE ALCOHOL PAD PATCH [KINGSTAR MEDICAL (XIANNING) CO., LTD.]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "43598-126_61347918-bb33-236c-6a2e-280b59e7ab31",
  "productndc": "43598-126",
  "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": "WATER",
  "proprietary_name": "Sterile Diluent for Treprostinil",
  "active_ingred_unit": "mL/mL",
  "application_number": "ANDA210214",
  "marketing_category": "ANDA",
  "nonproprietary_name": "water",
  "start_marketing_date": "20230213",
  "active_numerator_strength": "1"
}

Access this data programmatically

Query Sterile Diluent for Treprostinil and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs