NDC 0054-0245

Codeine sulfate

Codeine Sulfate

Codeine sulfate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Codeine Sulfate.

• Product ID: 0054-0245_45ae2b1b-8f8f-4189-af20-72b61d46298b
• NDC: 0054-0245
• Product Type: Human Prescription Drug
• Proprietary Name: Codeine sulfate
• Generic Name: Codeine Sulfate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-16
• Marketing Category: NDA / NDA
• Application Number: NDA022402
• Labeler Name: West-Ward Pharmaceuticals Corp.
• 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: 2020-12-31

Packaging

NDC 0054-0245-25

100 TABLET in 1 BOTTLE (0054-0245-25)

• Marketing Start Date: 2009-07-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0054-0245-25 [00054024525]

Codeine sulfate TABLET

• Marketing Category: NDA
• Application Number: NDA022402
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-07-16

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE SULFATE	60 mg/1

OpenFDA Data

• SPL SET ID: 010905f9-3bcb-4b50-9fe8-a3ad0010f14c
• Manufacturer:
  • West-Ward Pharmaceuticals Corp.
• UNII:
  • 11QV9BS0CB
• RxNorm Concept Unique ID - RxCUI:
  • 997287
  • 997296
• UPC Code:
  • 0300540244255
  • 0300540245252

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