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United States · US · US:0054-0021_5e0351f3-360d-4044-a40a-a36f0008cf92

Lithium Carbonate

Orange BookUNIISPLATC N05AN01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN05AN01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0054002125
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-25)
  • ndc11
    0054002129
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0021-29)

Annotations

UNII (FDA Substance ID)
2BMD2GNA4V
LITHIUM CARBONATE
RxCUI 42351
Orange Book
A076832
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": "0054-0021_5e0351f3-360d-4044-a40a-a36f0008cf92",
  "productndc": "0054-0021",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076832",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Oct 28, 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": "ANDA076832",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lithium Carbonate",
  "start_marketing_date": "20041028",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code N05AN01.

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