0440-8195 : Promethazine Hydrochloride 25 mg/1 Oral Tablet

NDC:	0440-8195
Labeler:	Liberty Pharmaceuticals, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Promethazine Hydrochloride
Dosage Form:	Oral Tablet
Application #:	ANDA040712
Rev. Date:	Jul 17, 2012
CSA Schedule:	CIV (US) [1]

^[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	K;3
Shapes:	Round
Colors:	White
Size (mm):	8
Segments: *	4
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 4 indicates a scored pill which can be broken into 4 equal pieces.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

• 0440-8195-12: 12 TABLET IN 1 BOTTLE, PLASTIC (0440‑8195‑12)

Active Ingredients:

• Promethazine Hydrochloride

Inactive Ingredients:

• Lactose Monohydrate
• Magnesium Stearate
• Methylcellulose (100 Mpa.s)

Pharmaceutical Classes:

• Phenothiazine [EPC]
• Phenothiazines [CS]

Related Products:

Based on records with the same trade name.

• 0440-5195 Promethazine Hydrochloride 25 mg Oral Tablet by Liberty Pharmaceuticals, Inc.
• 0115-1040 Promethazine Hydrochloride 12.5 mg Oral Tablet by Global Pharmaceuticals, Division of Impax Laboratories Inc.
• 0115-1041 Promethazine Hydrochloride 25 mg Oral Tablet by Global Pharmaceuticals, Division of Impax Laboratories Inc.
• 0115-1042 Promethazine Hydrochloride 50 mg Oral Tablet by Global Pharmaceuticals, Division of Impax Laboratories Inc.
• 0121-0927 Promethazine Hydrochloride 6.25 mg/5ml Oral Solution by Pharmaceutical Associates, Inc.
• 0143-9868 Promethazine Hydrochloride 50 mg/ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp
• 0143-9869 Promethazine Hydrochloride 25 mg/ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp
• 0378-7028 Promethazine Hydrochloride 12.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 0378-7029 Promethazine Hydrochloride 25 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 0378-7030 Promethazine Hydrochloride 50 mg Oral Tablet by Mylan Pharmaceuticals Inc.
• 0404-9940 Promethazine Hydrochloride 25 mg/ml Intramuscular; Intravenous Injection by Henry Schein, Inc.
• 0404-9941 Promethazine Hydrochloride 25 mg/ml Intramuscular; Intravenous Injection by Henry Schein, Inc.
• 0404-9942 Promethazine Hydrochloride 50 mg/ml Intramuscular Injection by Henry Schein, Inc.
• 0409-2312 Promethazine Hydrochloride 25 mg/ml Intramuscular; Intravenous Injection, Solution by Hospira, Inc.
• 0591-5307 Promethazine Hydrochloride 25 mg Oral Tablet by Watson Laboratories, Inc.
• 0591-5319 Promethazine Hydrochloride 50 mg Oral Tablet by Watson Laboratories, Inc.
• 0603-1584 Promethazine Hydrochloride 6.25 mg/5ml Oral Syrup by Qualitest Pharmaceuticals
• 0603-5437 Promethazine Hydrochloride 12.5 mg Oral Tablet by Qualitest Pharmaceuticals
• 0603-5438 Promethazine Hydrochloride 25 mg Oral Tablet by Qualitest Pharmaceuticals
• 0603-5439 Promethazine Hydrochloride 50 mg Oral Tablet by Qualitest Pharmaceuticals
• More related products ...

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