NDC 0527-1398

Phentermine Resin ER

Phentermine Resin

Phentermine Resin ER is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Phentermine.

• Product ID: 0527-1398_7bbef403-d696-4690-a1b1-8fd2d48eb52e
• NDC: 0527-1398
• Product Type: Human Prescription Drug
• Proprietary Name: Phentermine Resin ER
• Generic Name: Phentermine Resin
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2011-07-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040872
• Labeler Name: Lannett Company, Inc.
• Substance Name: PHENTERMINE
• Active Ingredient Strength: 15 mg/1
• Pharm Classes: Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0527-1398-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-1398-01)

• Marketing Start Date: 2011-07-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0527-1398-01 [00527139801]

Phentermine Resin ER CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA040872
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-07-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PHENTERMINE	15 mg/1

OpenFDA Data

• SPL SET ID: 7ca86c66-409b-4852-8631-c3ada6e60738
• Manufacturer:
  • Lannett Company, Inc.
• UNII:
  • C045TQL4WP
• RxNorm Concept Unique ID - RxCUI:
  • 826586
  • 826832
• UPC Code:
  • 0305271366016
  • 0305271398017

Pharmacological Class

• Appetite Suppression [PE]
• Increased Sympathetic Activity [PE]
• Sympathomimetic Amine Anorectic [EPC]

NDC Crossover Matching brand name "Phentermine Resin ER" or generic name "Phentermine Resin"

NDC	Brand Name	Generic Name
0527-1366	Phentermine Resin	Phentermine Resin
0527-1398	Phentermine Resin	Phentermine Resin