52959-118 : Promethazine With Codeine Oral Syrup

NDC:	52959-118
Labeler:	H.j. Harkins Company, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Promethazine With Codeine
Dosage Form:	Oral Syrup
Application #:	ANDA088875
Rev. Date:	Dec 8, 2015
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:

• 52959-118-04: 118 ML IN 1 BOTTLE, PLASTIC (52959‑118‑04)
• 52959-118-08: 236 ML IN 1 BOTTLE, PLASTIC (52959‑118‑08)

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.

• 0121-0928 Promethazine With Codeine Oral Solution by Pharmaceutical Associates, Inc.
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• 12634-909 Promethazine With Codeine Oral Liquid by Apotheca, Inc.
• 17856-0605 Promethazine With Codeine Oral Solution by Atlantic Biologicals Corp.
• 17856-1585 Promethazine With Codeine Oral Syrup by Atlantic Biologicals Corps
• 21695-336 Promethazine With Codeine Oral Syrup by Rebel Distributors Corp
• 33261-391 Promethazine With Codeine Oral Syrup by Aidarex Pharmaceuticals LLC
• 49999-152 Promethazine With Codeine Oral Syrup by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
• 50090-2247 Promethazine With Codeine Oral Syrup by A-s Medication Solutions
• 50090-4127 Promethazine With Codeine Oral Solution by A-s Medication Solutions
• 50436-1029 Promethazine With Codeine Oral Syrup by Unit Dose Services
• 53002-3270 Promethazine With Codeine Oral Solution by Rpk Pharmaceuticals, Inc.
• 54569-1056 Promethazine With Codeine Oral Syrup by A-s Medication Solutions LLC
• 54868-1029 Promethazine With Codeine Oral Syrup by Physicians Total Care, Inc.
• 63187-271 Promethazine With Codeine Oral Syrup by Proficient Rx Lp
• 67296-0516 Promethazine With Codeine Oral Solution by Redpharm Drug, Inc.
• 68071-1606 Promethazine With Codeine Oral Solution by Nucare Pharmaceuticals, Inc.
• 68071-4037 Promethazine With Codeine Oral Solution by Nucare Pharmaceuticals, Inc.
• 68788-9895 Promethazine With Codeine Oral Syrup by Preferred Pharmaceuticals, Inc
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