NDC 10191-1035

CODEINUM

Codeine

CODEINUM is a Sublingual Pellet in the Human Prescription Drug category. It is labeled and distributed by Remedy Makers. The primary component is Codeine Anhydrous.

• Product ID: 10191-1035_1b04bb5f-aaa5-12ed-e054-00144ff8d46c
• NDC: 10191-1035
• Product Type: Human Prescription Drug
• Proprietary Name: CODEINUM
• Generic Name: Codeine
• Dosage Form: Pellet
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2015-07-14
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: Remedy Makers
• Substance Name: CODEINE ANHYDROUS
• Active Ingredient Strength: 9 [hp_X]/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 10191-1035-2

170 PELLET in 1 VIAL, GLASS (10191-1035-2)

• Marketing Start Date: 2015-07-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10191-1035-2 [10191103502]

CODEINUM PELLET

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-07-14
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE ANHYDROUS	9 [hp_X]/1

OpenFDA Data

• SPL SET ID: 1b04bb5f-aaa4-12ed-e054-00144ff8d46c
• Manufacturer:
  • Remedy Makers
• UNII:
  • UX6OWY2V7J
• UPC Code:
  • 0310191103528

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
10191-1033	CODEINUM	CODEINE
10191-1034	CODEINUM	CODEINE
10191-1035	CODEINUM	CODEINE
10191-1036	CODEINUM	CODEINE
10191-1037	CODEINUM	CODEINE
10191-1038	CODEINUM	CODEINE
10191-1045	CODEINUM	CODEINE BASE