NDC 0527-1699

Codeine Sulfate

Codeine Sulfate

Codeine Sulfate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Codeine Sulfate.

• Product ID: 0527-1699_3db82243-1649-4470-91af-af12a932f456
• NDC: 0527-1699
• Product Type: Human Prescription Drug
• Proprietary Name: Codeine Sulfate
• Generic Name: Codeine Sulfate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-06-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203046
• Labeler Name: Lannett Company, Inc.
• Substance Name: CODEINE SULFATE
• Active Ingredient Strength: 60 mg/1
• Pharm Classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0527-1699-01

100 TABLET in 1 BOTTLE (0527-1699-01)

• Marketing Start Date: 2014-06-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0527-1699-01 [00527169901]

Codeine Sulfate TABLET

• Marketing Category: ANDA
• Application Number: ANDA203046
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-06-13

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE SULFATE	60 mg/1

OpenFDA Data

• SPL SET ID: 5819bdf7-300e-45b8-8f3a-447b53656293
• Manufacturer:
  • Lannett Company, Inc.
• UNII:
  • 11QV9BS0CB
• RxNorm Concept Unique ID - RxCUI:
  • 997287
  • 997170
  • 997296
• UPC Code:
  • 0305271698018
  • 0305271699015

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

NDC Crossover Matching brand name "Codeine Sulfate" or generic name "Codeine Sulfate"

NDC	Brand Name	Generic Name
0054-0243	Codeine sulfate	codeine sulfate
0054-0244	Codeine sulfate	codeine sulfate
0054-0245	Codeine sulfate	codeine sulfate
0527-1698	Codeine Sulfate	Codeine Sulfate
0527-1699	Codeine Sulfate	Codeine Sulfate
0527-1727	Codeine Sulfate	Codeine Sulfate