MedPath
FDA Approval

Phentermine Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
UNIT DOSE SERVICES
DUNS: 831995316
Effective Date
February 27, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

UNIT DOSE SERVICES

UNIT DOSE SERVICES

831995316

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Phentermine Hydrochloride

Product Details

NDC Product Code
50436-3175
Application Number
ANDA040886
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 16, 2023
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
Code: 0K2I505OTVClass: ACTIBQuantity: 30 mg in 1 1
© Copyright 2025. All Rights Reserved by MedPath