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 CAPSULE
Routes
ORAL
Active Ingredients

phentermine hydrochloride 30 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-586
Product ID 76420-586_04472220-f8f9-1f1a-e063-6294a90a2bb2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205019
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 76420586
Hyphenated Format 76420-586

Supplemental Identifiers

RxCUI
900038 968766
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 ANDA205019 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (76420-586-10)
  • 30 CAPSULE in 1 BOTTLE (76420-586-30)
  • 60 CAPSULE in 1 BOTTLE (76420-586-60)
  • 90 CAPSULE in 1 BOTTLE (76420-586-90)
source: ndc

Packages (4)

76420-586-10 100 CAPSULE in 1 BOTTLE (76420-586-10) 76420-586-30 30 CAPSULE in 1 BOTTLE (76420-586-30) 76420-586-60 60 CAPSULE in 1 BOTTLE (76420-586-60) 76420-586-90 90 CAPSULE in 1 BOTTLE (76420-586-90)

Ingredients (1)

phentermine hydrochloride (30 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": "04472220-f8f9-1f1a-e063-6294a90a2bb2", "openfda": {"unii": ["0K2I505OTV"], "rxcui": ["900038", "968766"], "spl_set_id": ["22683183-a828-47a4-9e52-38175d7c6f21"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76420-586-10)", "package_ndc": "76420-586-10", "marketing_start_date": "20230901"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (76420-586-30)", "package_ndc": "76420-586-30", "marketing_start_date": "20230901"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (76420-586-60)", "package_ndc": "76420-586-60", "marketing_start_date": "20230901"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (76420-586-90)", "package_ndc": "76420-586-90", "marketing_start_date": "20230901"}], "brand_name": "Phentermine Hydrochloride", "product_id": "76420-586_04472220-f8f9-1f1a-e063-6294a90a2bb2", "dosage_form": "CAPSULE", "pharm_class": ["Appetite Suppression [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic Amine Anorectic [EPC]"], "product_ndc": "76420-586", "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": "30 mg/1"}], "application_number": "ANDA205019", "marketing_category": "ANDA", "marketing_start_date": "20170124", "listing_expiration_date": "20261231"}