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United States · US · US:15370-305_4d2a603a-e0f8-43d4-a726-af60ffc6e744

POKONZA

In shortageOrange BookUNIISPLATC A12BA51

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

Identification

ManufacturerCarwin Pharmaceutical Associates, LLC
CountryUS (United States)
ATC codeA12BA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1537030504
    4 POUCH in 1 CARTON (15370-305-04) / .79 g in 1 POUCH (15370-305-01)
  • ndc11
    1537030530
    30 POUCH in 1 CARTON (15370-305-30) / .79 g in 1 POUCH (15370-305-01)
  • ndc11
    1537030560
    60 POUCH in 1 CARTON (15370-305-60) / .79 g in 1 POUCH (15370-305-01)

Annotations

UNII (FDA Substance ID)
660YQ98I10
POTASSIUM CHLORIDE
RxCUI 8591
Orange Book
N208019
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Potassium Citrate Tablet, Extended Release
Raw payload (JSON)
{
  "unii": {
    "unii": "660YQ98I10",
    "rxcui": "8591",
    "inchikey": "WCUXLLCKKVVCTQ-UHFFFAOYSA-M",
    "display_name": "POTASSIUM CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2d938cbf-27aa-4f9c-a582-5564d3b72465": {
      "match": "brand_token",
      "title": "POKONZA POTASSIUM CHLORIDE (POTASSIUM CHLORIDE) LIQUID [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]",
      "spl_version": "1",
      "published_date": "2026-01-30"
    }
  },
  "productid": "15370-305_4d2a603a-e0f8-43d4-a726-af60ffc6e744",
  "productndc": "15370-305",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "208019",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "20MEQ",
        "product_no": "001",
        "approval_date": "Aug 19, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MEQ",
        "product_no": "002",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40MEQ",
        "product_no": "003",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15MEQ",
        "product_no": "004",
        "approval_date": "Nov 12, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POTASSIUM CHLORIDE",
  "shortage_reason": "Potassium Citrate Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "POKONZA",
  "active_ingred_unit": "g/.79g",
  "application_number": "NDA208019",
  "marketing_category": "NDA",
  "nonproprietary_name": "Potassium Chloride",
  "start_marketing_date": "20230919",
  "active_numerator_strength": ".75"
}

Related drugs

Other records sharing ATC code A12BA51.

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