phentermine hydrochloride

Generic: phentermine hydrochloride

Labeler: solco healthcare u.s., llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phentermine hydrochloride
Generic Name phentermine hydrochloride
Labeler solco healthcare u.s., llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phentermine hydrochloride 37.5 mg/1

Manufacturer
Solco Healthcare U.S., LLC

Identifiers & Regulatory

Product NDC 43547-404
Product ID 43547-404_e7560e52-6bb6-4f57-be5b-5132bb9f5471
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040377
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2002-01-04

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 43547404
Hyphenated Format 43547-404

Supplemental Identifiers

RxCUI
803353
UPC
0343547404031
UNII
0K2I505OTV

Packaging Origin

Original Packager
true

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 ANDA040377 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 37.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (43547-404-03)
  • 100 TABLET in 1 BOTTLE, PLASTIC (43547-404-10)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (43547-404-11)
  • 500 TABLET in 1 BOTTLE, PLASTIC (43547-404-50)
source: ndc

Packages (4)

43547-404-03 30 TABLET in 1 BOTTLE, PLASTIC (43547-404-03) 43547-404-10 100 TABLET in 1 BOTTLE, PLASTIC (43547-404-10) 43547-404-11 1000 TABLET in 1 BOTTLE, PLASTIC (43547-404-11) 43547-404-50 500 TABLET in 1 BOTTLE, PLASTIC (43547-404-50)

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": "e7560e52-6bb6-4f57-be5b-5132bb9f5471", "openfda": {"upc": ["0343547404031"], "unii": ["0K2I505OTV"], "rxcui": ["803353"], "spl_set_id": ["e4024b8a-25cb-4681-9bb4-44a38c74fe4b"], "manufacturer_name": ["Solco Healthcare U.S., LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43547-404-03)", "package_ndc": "43547-404-03", "marketing_start_date": "20020104"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (43547-404-10)", "package_ndc": "43547-404-10", "marketing_start_date": "20020104"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (43547-404-11)", "package_ndc": "43547-404-11", "marketing_start_date": "20170104"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (43547-404-50)", "package_ndc": "43547-404-50", "marketing_start_date": "20250421"}], "brand_name": "Phentermine Hydrochloride", "product_id": "43547-404_e7560e52-6bb6-4f57-be5b-5132bb9f5471", "dosage_form": "TABLET", "pharm_class": ["Appetite Suppression [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic Amine Anorectic [EPC]"], "product_ndc": "43547-404", "dea_schedule": "CIV", "generic_name": "Phentermine Hydrochloride", "labeler_name": "Solco Healthcare U.S., LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phentermine Hydrochloride", "active_ingredients": [{"name": "PHENTERMINE HYDROCHLORIDE", "strength": "37.5 mg/1"}], "application_number": "ANDA040377", "marketing_category": "ANDA", "marketing_start_date": "20020104", "listing_expiration_date": "20261231"}