Codeine Sulfate

Orange BookUNIISPLATC N02AA59

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

Identification

ManufacturerLannett Company, Inc.

CountryUS (United States)

ATC codeN02AA59

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0527169801
100 TABLET in 1 BOTTLE (0527-1698-01)
ndc11
0527169891
4 BLISTER PACK in 1 CARTON (0527-1698-91) / 25 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

11QV9BS0CB

CODEINE SULFATE

RxCUI 91104

Orange Book

A203046

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": "0527-1698_aa8c1550-c22e-4945-8664-7a3d66523843",
  "productndc": "0527-1698",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203046",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Jun 13, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jun 13, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "003",
        "approval_date": "Jun 13, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CODEINE SULFATE",
  "proprietary_name": "Codeine Sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203046",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Codeine Sulfate",
  "start_marketing_date": "20140613",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code N02AA59.

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