codeine sulfate

Generic: codeine sulfate

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name codeine sulfate
Generic Name codeine sulfate
Labeler lannett company, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

codeine sulfate 15 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-1727
Product ID 0527-1727_aa8c1550-c22e-4945-8664-7a3d66523843
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203046
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2014-06-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05271727
Hyphenated Format 0527-1727

Supplemental Identifiers

RxCUI
997170 997287 997296
UPC
0305271699015
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 ANDA203046 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (0527-1727-91) / 25 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0527-1727-91 4 BLISTER PACK in 1 CARTON (0527-1727-91) / 25 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": "aa8c1550-c22e-4945-8664-7a3d66523843", "openfda": {"upc": ["0305271699015"], "unii": ["11QV9BS0CB"], "rxcui": ["997170", "997287", "997296"], "spl_set_id": ["5819bdf7-300e-45b8-8f3a-447b53656293"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (0527-1727-91)  / 25 TABLET in 1 BLISTER PACK", "package_ndc": "0527-1727-91", "marketing_start_date": "20140613"}], "brand_name": "Codeine Sulfate", "product_id": "0527-1727_aa8c1550-c22e-4945-8664-7a3d66523843", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0527-1727", "dea_schedule": "CII", "generic_name": "Codeine Sulfate", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Codeine Sulfate", "active_ingredients": [{"name": "CODEINE SULFATE", "strength": "15 mg/1"}], "application_number": "ANDA203046", "marketing_category": "ANDA", "marketing_start_date": "20140613", "listing_expiration_date": "20271231"}