NDC 54348-015

ACETAMINOPHEN with CODEINE

Acetaminophen, Codeine Phosphate

ACETAMINOPHEN with CODEINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pharmpak, Inc.. The primary component is Codeine Phosphate; Acetaminophen.

• Product ID: 54348-015_ab7b039f-49a0-4c2b-b1ad-b14e89448cc8
• NDC: 54348-015
• Product Type: Human Prescription Drug
• Proprietary Name: ACETAMINOPHEN with CODEINE
• Generic Name: Acetaminophen, Codeine Phosphate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-12-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA089805
• Labeler Name: PharmPak, Inc.
• Substance Name: CODEINE PHOSPHATE; ACETAMINOPHEN
• Active Ingredient Strength: 30 mg/1; mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CIII
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 54348-015-01

1 BLISTER PACK in 1 BOX (54348-015-01) > 1 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2013-12-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54348-015-01 [54348001501]

ACETAMINOPHEN with CODEINE TABLET

• Marketing Category: ANDA
• Application Number: ANDA089805
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-12-31
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE PHOSPHATE	30 mg/1

OpenFDA Data

• SPL SET ID: 36adb32c-638c-4d6e-b66a-1a1c35174ce6
• Manufacturer:
  • PharmPak, Inc.
• UNII:
  • GSL05Y1MN6
  • 362O9ITL9D
• RxNorm Concept Unique ID - RxCUI:
  • 993781

Pharmacological Class

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