0527-1438 NDC - PHENTERMINE HYDROCHLORIDE

Drug Information

Product NDC: 0527-1438

Proprietary Name: Phentermine Hydrochloride

Non Proprietary Name: Phentermine Hydrochloride

Active Ingredient(s):
  • 30 mg/1 PHENTERMINE HYDROCHLORIDE


Administration Route(s): ORAL

Dosage Form(s): CAPSULE

Pharmacy Class(es):
  • Appetite Suppression [PE];
  • Increased Sympathetic Activity [PE];
  • Sympathomimetic Amine Anorectic [EPC]

Labeler Information

Labeler Name: Lannett Company, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA091359
Marketing Category: ANDA
Start Marketing Date:7/19/2010
DEA Schedule:CIV

Package Information

No. Package Code Package Description Billing Unit
10527-1438-01100 CAPSULE in 1 BOTTLE (0527-1438-01)EA
20527-1438-101000 CAPSULE in 1 BOTTLE (0527-1438-10)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0527-1438The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEPhentermine HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEPhentermine HydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/19/2010This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA091359This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMELannett Company, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEPHENTERMINE HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH30 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESAppetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] 
DEA SCHEDULECIVThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 8/3/2018