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United States · US · US:43063-901_415d2a6b-7242-213c-e063-6294a90a5092

Lithium Carbonate

Orange BookUNIISPLATC N05AN01

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05AN01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4306390101
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-901-01)
  • ndc11
    4306390130
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-901-30)

Annotations

UNII (FDA Substance ID)
2BMD2GNA4V
LITHIUM CARBONATE
RxCUI 42351
Orange Book
A076691
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2BMD2GNA4V",
    "rxcui": "42351",
    "inchikey": "XGZVUEUWXADBQD-UHFFFAOYSA-L",
    "display_name": "LITHIUM CARBONATE",
    "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": "43063-901_415d2a6b-7242-213c-e063-6294a90a5092",
  "productndc": "43063-901",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076691",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "450MG",
        "product_no": "001",
        "approval_date": "Jan 5, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LITHIUM CARBONATE",
  "proprietary_name": "Lithium Carbonate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076691",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lithium Carbonate",
  "start_marketing_date": "20040113",
  "active_numerator_strength": "450"
}

Related drugs

Other records sharing ATC code N05AN01.

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