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United States · US · US:71656-072_3ccc30e9-1f5d-5715-e063-6394a90a6bc1

Lithium

Orange BookUNIISPLATC N05AN01

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

Identification

ManufacturerSaptalis Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN05AN01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7165607216
    473 mL in 1 BOTTLE (71656-072-16)
  • ndc11
    7165607250
    5 TRAY in 1 CASE (71656-072-50) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (71656-072-05)

Annotations

UNII (FDA Substance ID)
5Z6E9K79YV
LITHIUM CITRATE
RxCUI 52105
Orange Book
A217183
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": "71656-072_3ccc30e9-1f5d-5715-e063-6394a90a6bc1",
  "productndc": "71656-072",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "217183",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 300MG CARBONATE/5ML",
        "product_no": "001",
        "approval_date": "Mar 18, 2024"
      }
    ],
    "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": "ANDA217183",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lithium",
  "start_marketing_date": "20240328",
  "active_numerator_strength": "8"
}

Related drugs

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