Potassium Citrate

In shortageOrange BookUNIISPLATC A12BA02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.

CountryUS (United States)

ATC codeA12BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6838253701
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-537-01)
ndc11
6838253705
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-537-05)
ndc11
6838253706
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-537-06)
ndc11
6838253710
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-537-10)
ndc11
6838253716
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-537-16)
ndc11
6838253730
10 BLISTER PACK in 1 CARTON (68382-537-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

EE90ONI6FF

POTASSIUM CITRATE

RxCUI 221149

Orange Book

A203546

ABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Potassium Citrate Tablet, Extended Release

Raw payload (JSON)

{
  "unii": {
    "unii": "EE90ONI6FF",
    "rxcui": "221149",
    "inchikey": "PJAHUDTUZRZBKM-UHFFFAOYSA-K",
    "display_name": "POTASSIUM CITRATE",
    "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": "68382-537_b0382b88-fcc4-44de-b66d-a93dabc596f8",
  "productndc": "68382-537",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203546",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MEQ",
        "product_no": "001",
        "approval_date": "Aug 6, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MEQ",
        "product_no": "002",
        "approval_date": "Aug 6, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MEQ",
        "product_no": "003",
        "approval_date": "Aug 6, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POTASSIUM CITRATE",
  "shortage_reason": "Potassium Citrate Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Potassium Citrate",
  "active_ingred_unit": "meq/1",
  "application_number": "ANDA203546",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Potassium Citrate",
  "start_marketing_date": "20140812",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code A12BA02.

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