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United States · US · US:68094-077_78d523ef-d924-4154-9b2b-3d5a79a75052

Lithium

Orange BookUNIISPLATC N05AN01

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

Identification

ManufacturerPrecision Dose, Inc.
CountryUS (United States)
ATC codeN05AN01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6809407762
    3 TRAY in 1 CASE (68094-077-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-077-59)

Annotations

UNII (FDA Substance ID)
5Z6E9K79YV
LITHIUM CITRATE
RxCUI 52105
Orange Book
A218036
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5Z6E9K79YV",
    "rxcui": "52105",
    "inchikey": "HXGWMCJZLNWEBC-UHFFFAOYSA-K",
    "display_name": "LITHIUM CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "51b503f5-211f-a9cc-e063-6294a90a9895": {
      "match": "brand_token",
      "title": "LITHIUM CARBONATE ER (LITHIUM CARBONATE) TABLET [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-14"
    }
  },
  "productid": "68094-077_78d523ef-d924-4154-9b2b-3d5a79a75052",
  "productndc": "68094-077",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "218036",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 300MG CARBONATE/5ML",
        "product_no": "001",
        "approval_date": "Aug 14, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LITHIUM CITRATE",
  "proprietary_name": "Lithium",
  "active_ingred_unit": "meq/5mL",
  "application_number": "ANDA218036",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lithium Citrate",
  "start_marketing_date": "20251024",
  "active_numerator_strength": "8"
}

Related drugs

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