Lithium Carbonate

Orange BookUNIISPLATC N05AN01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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
0054252725
100 CAPSULE, GELATIN COATED in 1 BOTTLE (0054-2527-25)
ndc11
0054252731
1000 CAPSULE, GELATIN COATED in 1 BOTTLE (0054-2527-31)

Annotations

UNII (FDA Substance ID)

2BMD2GNA4V

LITHIUM CARBONATE

RxCUI 42351

Orange Book

N017812

ABABAB

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": "0054-2527_a9e58e66-6569-4c3b-993f-b4236904296e",
  "productndc": "0054-2527",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "017812",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Jan 28, 1987"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Jan 28, 1987"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LITHIUM CARBONATE",
  "proprietary_name": "Lithium Carbonate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA017812",
  "marketing_category": "NDA",
  "nonproprietary_name": "Lithium Carbonate",
  "start_marketing_date": "19801126",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code N05AN01.

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