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United States · US · US:0310-6627_a84753f1-6ac5-4a47-a382-29972938ccaa

SymlinPen

In shortageOrange BookUNIISPLATC A10BX05

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

Identification

ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeA10BX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0310662702
    2 CARTRIDGE in 1 CARTON (0310-6627-02) / 2.7 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)
726I6TE06G
PRAMLINTIDE ACETATE
RxCUI 356773
Orange Book
N021332
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pramlintide Acetate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "726I6TE06G",
    "rxcui": "356773",
    "inchikey": null,
    "display_name": "PRAMLINTIDE ACETATE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "4aea30ff-eb0d-45c1-b114-3127966328ff": {
      "match": "brand_token",
      "title": "SYMLINPEN (PRAMLINTIDE ACETATE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]",
      "spl_version": "18",
      "published_date": "2024-08-20"
    }
  },
  "productid": "0310-6627_a84753f1-6ac5-4a47-a382-29972938ccaa",
  "productndc": "0310-6627",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "021332",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)",
        "product_no": "001",
        "approval_date": "Mar 16, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Sep 25, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Sep 25, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRAMLINTIDE ACETATE",
  "shortage_reason": "Pramlintide Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "SymlinPen",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA021332",
  "marketing_category": "NDA",
  "nonproprietary_name": "pramlintide acetate",
  "start_marketing_date": "20150108",
  "active_numerator_strength": "1000"
}

Related drugs

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