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United States · US · US:43386-169_b48fb85d-87f5-0c70-e053-2a95a90a7011

POTASSIUM CHLORIDE

In shortageOrange BookUNIISPLATC A12BA51

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

Identification

ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeA12BA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4338616901
    473 mL in 1 BOTTLE (43386-169-01)

Annotations

UNII (FDA Substance ID)
660YQ98I10
POTASSIUM CHLORIDE
RxCUI 8591
Orange Book
A209786
AAAA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Potassium Chloride 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": {
    "ff67f638-5b53-406a-962a-87773a91fc48": {
      "match": "brand_token",
      "title": "POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-05-28"
    }
  },
  "productid": "43386-169_b48fb85d-87f5-0c70-e053-2a95a90a7011",
  "productndc": "43386-169",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "209786",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "20MEQ/15ML",
        "product_no": "001",
        "approval_date": "Aug 29, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "40MEQ/15ML",
        "product_no": "002",
        "approval_date": "Aug 29, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POTASSIUM CHLORIDE",
  "shortage_reason": "Potassium Chloride Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "POTASSIUM CHLORIDE",
  "active_ingred_unit": "meq/15mL",
  "application_number": "ANDA209786",
  "marketing_category": "ANDA",
  "nonproprietary_name": "POTASSIUM CHLORIDE",
  "start_marketing_date": "20180924",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code A12BA51.

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