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 ID0527-1398_7bbef403-d696-4690-a1b1-8fd2d48eb52e
NDC0527-1398
Product TypeHuman Prescription Drug
Proprietary NamePhentermine Resin ER
Generic NamePhentermine Resin
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-07-28
Marketing CategoryANDA / ANDA
Application NumberANDA040872
Labeler NameLannett Company, Inc.
Substance NamePHENTERMINE
Active Ingredient Strength15 mg/1
Pharm ClassesAppetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0527-1398-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-1398-01)
Marketing Start Date2011-07-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-1398-01 [00527139801]

Phentermine Resin ER CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040872
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PHENTERMINE15 mg/1

OpenFDA Data

SPL SET ID:7ca86c66-409b-4852-8631-c3ada6e60738
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0527-1366Phentermine ResinPhentermine Resin
    0527-1398Phentermine ResinPhentermine Resin

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