codeine sulfate

Generic: codeine sulfate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name codeine sulfate
Generic Name codeine sulfate
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

codeine sulfate 15 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0243
Product ID 0054-0243_b04f74f8-d960-4b7a-988a-372d9a1e1406
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022402
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2009-07-16

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540243
Hyphenated Format 0054-0243

Supplemental Identifiers

RxCUI
997170 997287 997296
UNII
11QV9BS0CB

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name codeine sulfate (source: ndc)
Generic Name codeine sulfate (source: ndc)
Application Number NDA022402 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BOX (0054-0243-24) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

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

Ingredients (1)

codeine sulfate (15 mg/1)

Linked Drug Pages (1)

Codeine sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b04f74f8-d960-4b7a-988a-372d9a1e1406", "openfda": {"unii": ["11QV9BS0CB"], "rxcui": ["997170", "997287", "997296"], "spl_set_id": ["010905f9-3bcb-4b50-9fe8-a3ad0010f14c"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BOX (0054-0243-24)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "0054-0243-24", "marketing_start_date": "20090716"}], "brand_name": "Codeine sulfate", "product_id": "0054-0243_b04f74f8-d960-4b7a-988a-372d9a1e1406", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0054-0243", "dea_schedule": "CII", "generic_name": "codeine sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Codeine sulfate", "active_ingredients": [{"name": "CODEINE SULFATE", "strength": "15 mg/1"}], "application_number": "NDA022402", "marketing_category": "NDA", "marketing_start_date": "20090716", "listing_expiration_date": "20261231"}