Codeine sulfate

Orange BookUNIISPLATC N02AA59

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN02AA59

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054024324
10 BLISTER PACK in 1 BOX (0054-0243-24) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

11QV9BS0CB

CODEINE SULFATE

RxCUI 91104

Orange Book

N022402

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "11QV9BS0CB",
    "rxcui": "91104",
    "inchikey": "BOLDZXRCJAJADM-AAXBYHQXSA-N",
    "display_name": "CODEINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5819bdf7-300e-45b8-8f3a-447b53656293": {
      "match": "brand_token",
      "title": "CODEINE SULFATE TABLET [LANNETT COMPANY, INC.]",
      "spl_version": "29",
      "published_date": "2026-02-05"
    }
  },
  "productid": "0054-0243_b04f74f8-d960-4b7a-988a-372d9a1e1406",
  "productndc": "0054-0243",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "022402",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Jul 16, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jul 16, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "Jul 16, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CODEINE SULFATE",
  "proprietary_name": "Codeine sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022402",
  "marketing_category": "NDA",
  "nonproprietary_name": "codeine sulfate",
  "start_marketing_date": "20090716",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code N02AA59.

Access this data programmatically

Query Codeine sulfate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs