phentermine hydrochloride

Generic: phentermine hydrochloride

Labeler: martek pharmacal co.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phentermine hydrochloride
Generic Name phentermine hydrochloride
Labeler martek pharmacal co.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phentermine hydrochloride 37.5 mg/1

Manufacturer
Martek Pharmacal Co.

Identifiers & Regulatory

Product NDC 84053-025
Product ID 84053-025_3a9b5a93-de52-2dd1-e063-6394a90a311d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040876
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-02-01

Pharmacologic Class

Classes
appetite suppression [pe] increased sympathetic activity [pe] sympathomimetic amine anorectic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84053025
Hyphenated Format 84053-025

Supplemental Identifiers

RxCUI
803353
UNII
0K2I505OTV

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name phentermine hydrochloride (source: ndc)
Generic Name phentermine hydrochloride (source: ndc)
Application Number ANDA040876 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 37.5 mg/1
source: ndc
Packaging
  • 7 TABLET in 1 BOTTLE (84053-025-07)
  • 14 TABLET in 1 BOTTLE (84053-025-14)
  • 28 TABLET in 1 BOTTLE (84053-025-28)
  • 56 TABLET in 1 BOTTLE (84053-025-56)
source: ndc

Packages (4)

84053-025-07 7 TABLET in 1 BOTTLE (84053-025-07) 84053-025-14 14 TABLET in 1 BOTTLE (84053-025-14) 84053-025-28 28 TABLET in 1 BOTTLE (84053-025-28) 84053-025-56 56 TABLET in 1 BOTTLE (84053-025-56)

Ingredients (1)

phentermine hydrochloride (37.5 mg/1)

Linked Drug Pages (1)

Phentermine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a9b5a93-de52-2dd1-e063-6394a90a311d", "openfda": {"unii": ["0K2I505OTV"], "rxcui": ["803353"], "spl_set_id": ["c4e9ec2e-4660-4442-93d7-c05a16e137b5"], "manufacturer_name": ["Martek Pharmacal Co."]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET in 1 BOTTLE (84053-025-07)", "package_ndc": "84053-025-07", "marketing_start_date": "20240201"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (84053-025-14)", "package_ndc": "84053-025-14", "marketing_start_date": "20240201"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (84053-025-28)", "package_ndc": "84053-025-28", "marketing_start_date": "20240201"}, {"sample": false, "description": "56 TABLET in 1 BOTTLE (84053-025-56)", "package_ndc": "84053-025-56", "marketing_start_date": "20240201"}], "brand_name": "Phentermine Hydrochloride", "product_id": "84053-025_3a9b5a93-de52-2dd1-e063-6394a90a311d", "dosage_form": "TABLET", "pharm_class": ["Appetite Suppression [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic Amine Anorectic [EPC]"], "product_ndc": "84053-025", "dea_schedule": "CIV", "generic_name": "Phentermine Hydrochloride", "labeler_name": "Martek Pharmacal Co.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phentermine Hydrochloride", "active_ingredients": [{"name": "PHENTERMINE HYDROCHLORIDE", "strength": "37.5 mg/1"}], "application_number": "ANDA040876", "marketing_category": "ANDA", "marketing_start_date": "20240201", "listing_expiration_date": "20261231"}