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United States · US · US:0338-0289_ed7dbe8e-a9a1-447a-9aab-654150b3d618

Glycine

Orange BookUNIISPLATC B05CX03

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeB05CX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0338028947
    3000 mL in 1 BAG (0338-0289-47)

Annotations

UNII (FDA Substance ID)
TE7660XO1C
GLYCINE
RxCUI 4919
Orange Book
N017865
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "TE7660XO1C",
    "rxcui": "4919",
    "inchikey": "DHMQDGOQFOQNFH-UHFFFAOYSA-N",
    "display_name": "GLYCINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "IRRIGATION",
  "spl_meta": {
    "d4665408-04d8-4ad7-8589-708d4defb869": {
      "match": "brand_token",
      "title": "GLYCINE SOLUTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "12",
      "published_date": "2026-02-26"
    }
  },
  "productid": "0338-0289_ed7dbe8e-a9a1-447a-9aab-654150b3d618",
  "productndc": "0338-0289",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "017865",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "1.5GM/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYCINE",
  "proprietary_name": "Glycine",
  "active_ingred_unit": "g/100mL",
  "application_number": "NDA017865",
  "marketing_category": "NDA",
  "nonproprietary_name": "Glycine",
  "start_marketing_date": "19800530",
  "active_numerator_strength": "1.5"
}

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