PHENTERMINE HYDROCHLORIDE- phentermine hydrochloride tablet 
Northwind Pharmaceuticals

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NDC: 51655-875-25

MFG: 53489-676-10

Phentermine HCL 37.5 MG C IV

60 tablets

Rx only

Lot#:

Exp. Date:

Each tablet contains: Phentermine hydrochloride, USP....37.5mg

Dosage: See package insert

Store at 68 to 77 degrees F.

Store in a tight, light-resistance container (See USP) Keep out of the reach of children.

Mfg by: Mutual Pharmaceuticals Co., Inc Philadelphia, PA 19124 Lot #

Distributed by: Northwind Pharmaceuticals, Indianapolis, IN 46256

Phentermine HCL 51655-875

NDC: 51655-875-90

Phentermine HCL 37.5 MG    C IV

45 Tablets             Rx Only

Lot:                      Exp:

Store at 20C to 25C (68-77F)

Manufactured by Mutual Pharmaceuticals Co Inc

Manufacture Address: Philadelphia, PA 19124

Manufacture NDC: 53489-676-10     Mfg Lot: 6677501

Distributed by: Northwind Pharmaceuticals Indianapolis, IN 46256

51655-875-90

NDC: 51655-875-24

Phentermine HCL 37.5 MG C IV

30 Tablets                 Rx Only

Lot:                          Exp:

Store at 20C to 25C (68-77F)

Manufactured by Mutual Pharmaceuticals Co Inc

Manufacture Address: Philadelphia, PA 19124

Manufacture NDC: 53489-676-10 Mfg Lot: 6677501

Distributed by: Northwind Pharmaceuticals Indianapolis, IN 46256

51655-875-24

NDC: 51655-875-25

Phentermine HCL 37.5 MG C IV

60 Tablets Rx Only

Lot: Exp:

Store at 20C to 25C (68-77F)

Manufactured by Mutual Pharmaceuticals Co Inc

Manufacture Address: Philadelphia, PA 19124

Manufacture NDC: 53489-676-10 Mfg Lot: 6677501

Distributed by: Northwind Pharmaceuticals Indianapolis, IN 46256

51655-875-25

Indications and Usage

Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1)

The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use

Dosage and Administration

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

Late evening administration should be avoided (risk of insomnia).

Phentermine hydrochloride tablets can be taken with or without food

Contraindications

History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) During or within 14 days following the administration of monoamine oxidase inhibitors

Hyperthyroidism

Glaucoma

Agitated states

History of drug abuse

Pregnancy

Nursing

Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines

Warning and Precautions

Coadministration with other drugs for weight loss is not recommended (safety and efficacy of combination not established). Rare cases of primary pulmonary hypertension have been reported. Phentermine should be discontinued in case of new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema. Rare cases of serious regurgitant cardiac valvular disease have been reported. Tolerance to the anorectic effect usually develops within a few weeks. If this occurs, phentermine should be discontinued. The recommended dose should not be exceeded. Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle. Risk of abuse and dependence. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Concomitant alcohol use may result in an adverse drug reaction. Use caution in patients with even mild hypertension (risk of increase in blood pressure). A reduction in dose of insulin or oral hypoglycemic medication may be required in some patients.

PHENTERMINE HYDROCHLORIDE 
phentermine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-875(NDC:53489-676)
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP) PHENTERMINE37.5 mg
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize13mm
FlavorImprint Code MP;273
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51655-875-2560 in 1 BOTTLE, DISPENSING
2NDC:51655-875-9045 in 1 BOTTLE, DISPENSING
3NDC:51655-875-2430 in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04052605/15/2014
Labeler - Northwind Pharmaceuticals (036986393)
Registrant - Northwind Pharmaceuticals (036986393)
Establishment
NameAddressID/FEIBusiness Operations
Northwind Pharmaceuticals036986393repack(51655-875)

Revised: 8/2014
Document Id: f34fbc55-732a-4573-a843-33c0f325571b
Set id: d1d74574-9ebc-45fc-86e9-8cbd59acacd4
Version: 2
Effective Time: 20140820
 
Northwind Pharmaceuticals