Back to search
🇺🇸

United States · US · US:76451-013_47d37f1c-3d95-ec07-e063-6394a90a8d2f

Ammonia

Orange BookUNIISPLATC V09GX05

Last synced from FDA National Drug Code directory (United States) on

Identification

Manufacturer3D Imaging Drug Design and Development LLC
CountryUS (United States)
ATC codeV09GX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7645101310
    10 mL in 1 VIAL, GLASS (76451-013-10)

Annotations

UNII (FDA Substance ID)
9OQO0E343Z
AMMONIA N-13
RxCUI 1305558
Orange Book
A203779
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9OQO0E343Z",
    "rxcui": "1305558",
    "inchikey": "QGZKDVFQNNGYKY-BJUDXGSMSA-N",
    "display_name": "AMMONIA N-13",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "61e196ba-3812-4ffd-8032-12b215378fef": {
      "match": "brand_token",
      "title": "AMMONIA N 13 (AMMONIA N-13) INJECTION [IONETIX CORPORATION]",
      "spl_version": "17",
      "published_date": "2026-03-30"
    }
  },
  "productid": "76451-013_47d37f1c-3d95-ec07-e063-6394a90a8d2f",
  "productndc": "76451-013",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "203779",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30mCi-300mCi/8ML (3.75-37.5mCi/ML)",
        "product_no": "001",
        "approval_date": "Oct 19, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMMONIA N-13",
  "proprietary_name": "Ammonia",
  "active_ingred_unit": "mCi/mL",
  "application_number": "ANDA203779",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMMONIA N-13",
  "start_marketing_date": "20120102",
  "active_numerator_strength": "37.5"
}

Related drugs

Other records sharing ATC code V09GX05.

Access this data programmatically

Query Ammonia 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.