63187-595 : Promethazine Hydrochloride and Codeine Phosphate Oral Syrup

NDC:	63187-595
Labeler:	Proficient Rx Lp
Product Type:	Human Prescription Drug
Drug Name:	Promethazine Hydrochloride and Codeine Phosphate
Dosage Form:	Oral Syrup
Application #:	ANDA090180
Rev. Date:	Mar 17, 2010
CSA Schedule:	CV (US) [1]

^[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

• 63187-595-04: 118 ML IN 1 BOTTLE (63187‑595‑04)

Active Ingredients:

• Promethazine Hydrochloride
• Codeine Phosphate

Pharmaceutical Classes:

• Phenothiazine [EPC]
• Phenothiazines [CS]
• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.

• 0121-0547 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Pharmaceutical Associates, Inc.
• 12634-907 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Apotheca, Inc
• 17856-0065 Promethazine Hydrochloride and Codeine Phosphate Oral Solution by Atlantic Biologicals Corp.
• 17856-0139 Promethazine Hydrochloride and Codeine Phosphate Oral Solution by Atlantic Biologicals Corp.
• 17856-0804 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Atlantic Biologicals Corps
• 27808-065 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Tris Pharma Inc
• 50090-1482 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by A-s Medication Solutions LLC
• 50383-804 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Hi-tech Pharmacal Co., Inc.
• 52125-587 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Remedyrepack Inc.
• 57664-185 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Caraco Pharmaceutical Laboratories, Ltd.
• 65162-695 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Amneal Pharmaceuticals LLC
• 68788-9385 Promethazine Hydrochloride and Codeine Phosphate Oral Syrup by Preferred Pharmaceuticals, Inc.
• 70408-185 Promethazine Hydrochloride and Codeine Phosphate Oral Solution by Nostrum Laboratories, Inc.
• 70752-139 Promethazine Hydrochloride and Codeine Phosphate Oral Solution by Quagen Pharmaceuticals LLC
• 72162-2042 Promethazine Hydrochloride and Codeine Phosphate Oral Solution by Bryant Ranch Prepack

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