phentermine hydrochloride

Generic: phentermine hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phentermine hydrochloride
Generic Name phentermine hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phentermine hydrochloride 37.5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-108
Product ID 76420-108_b2ddcdd0-7292-99df-e053-2a95a90a8818
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205008
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2017-01-24

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 76420108
Hyphenated Format 76420-108

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 ANDA205008 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 37.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (76420-108-30)
source: ndc

Packages (1)

76420-108-30 30 TABLET in 1 BOTTLE (76420-108-30)

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": "b2ddcdd0-7292-99df-e053-2a95a90a8818", "openfda": {"unii": ["0K2I505OTV"], "rxcui": ["803353"], "spl_set_id": ["de76ed27-ac43-4923-b73f-461d33941f6b"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-108-30)", "package_ndc": "76420-108-30", "marketing_start_date": "20201030"}], "brand_name": "Phentermine hydrochloride", "product_id": "76420-108_b2ddcdd0-7292-99df-e053-2a95a90a8818", "dosage_form": "TABLET", "pharm_class": ["Appetite Suppression [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic Amine Anorectic [EPC]"], "product_ndc": "76420-108", "dea_schedule": "CIV", "generic_name": "phentermine hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phentermine hydrochloride", "active_ingredients": [{"name": "PHENTERMINE HYDROCHLORIDE", "strength": "37.5 mg/1"}], "application_number": "ANDA205008", "marketing_category": "ANDA", "marketing_start_date": "20170124", "listing_expiration_date": "20261231"}