0472-1627 : Prometh With Codeine Oral Syrup

NDC:	0472-1627
Labeler:	Actavis Mid Atlantic LLC
Product Type:	Human Prescription Drug
Drug Name:	Prometh With Codeine
Dosage Form:	Oral Syrup
Application #:	ANDA088763
Rev. Date:	Jan 3, 2003
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:

• 0472-1627-04: 118 ML IN 1 BOTTLE (0472‑1627‑04)
• 0472-1627-08: 237 ML IN 1 BOTTLE (0472‑1627‑08)
• 0472-1627-16: 473 ML IN 1 BOTTLE (0472‑1627‑16)

Active Ingredients:

• Codeine Phosphate
• Promethazine Hydrochloride

Pharmaceutical Classes:

• Phenothiazine [EPC]
• Phenothiazines [Chemical/Ingredient]
• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.

• 42254-140 Prometh With Codeine Oral Syrup by Rebel Distributors Corp
• 52125-596 Prometh With Codeine Oral Syrup by Remedyrepack Inc.
• 63629-1607 Prometh With Codeine Oral Syrup by Bryant Ranch Prepack

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