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United States · US · US:43386-030_a1083256-d69a-4ff6-be4e-9719451792ef

Monobasic Sodium Phosphate and Dibasic Sodium Phosphate

In shortageOrange BookUNIISPL

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

Identification

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

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
22ADO53M6F
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
RxCUI 314838
Orange Book
A079247
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sodium Chloride 0.9% Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "22ADO53M6F",
    "rxcui": "314838",
    "inchikey": "BNIILDVGGAEEIG-UHFFFAOYSA-L",
    "display_name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e2fcc382-6fac-4438-ad02-ebc8528dd59a": {
      "match": "brand_token",
      "title": "MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE TABLET [LUPIN PHARMACEUTICALS,INC.]",
      "spl_version": "5",
      "published_date": "2024-01-31"
    }
  },
  "productid": "43386-030_a1083256-d69a-4ff6-be4e-9719451792ef",
  "productndc": "43386-030",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "079247",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.398GM;1.102GM",
        "product_no": "001",
        "approval_date": "Dec 30, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "Monobasic Sodium Phosphate and Dibasic Sodium Phosphate",
  "active_ingred_unit": "g/1; g/1",
  "application_number": "ANDA079247",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Monobasic Sodium Phosphate and Dibasic Sodium Phosphate",
  "start_marketing_date": "20120120",
  "active_numerator_strength": ".398; 1.105"
}

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