phentermine hydrochloride

Generic: phentermine hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phentermine hydrochloride
Generic Name phentermine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phentermine hydrochloride 37.5 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 53489-676
Product ID 53489-676_39e24c57-7266-2bf6-e063-6294a90afdd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040526
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2013-08-12

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 53489676
Hyphenated Format 53489-676

Supplemental Identifiers

RxCUI
803353
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 ANDA040526 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 37.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (53489-676-01)
  • 250 TABLET in 1 BOTTLE, PLASTIC (53489-676-03)
  • 500 TABLET in 1 BOTTLE, PLASTIC (53489-676-05)
  • 60 TABLET in 1 BOTTLE, PLASTIC (53489-676-06)
  • 30 TABLET in 1 BOTTLE, PLASTIC (53489-676-07)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (53489-676-10)
source: ndc

Packages (6)

53489-676-01 100 TABLET in 1 BOTTLE, PLASTIC (53489-676-01) 53489-676-03 250 TABLET in 1 BOTTLE, PLASTIC (53489-676-03) 53489-676-05 500 TABLET in 1 BOTTLE, PLASTIC (53489-676-05) 53489-676-06 60 TABLET in 1 BOTTLE, PLASTIC (53489-676-06) 53489-676-07 30 TABLET in 1 BOTTLE, PLASTIC (53489-676-07) 53489-676-10 1000 TABLET in 1 BOTTLE, PLASTIC (53489-676-10)

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": "39e24c57-7266-2bf6-e063-6294a90afdd1", "openfda": {"unii": ["0K2I505OTV"], "rxcui": ["803353"], "spl_set_id": ["02b8f684-b1ca-4ab7-9567-bcacc6a92779"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (53489-676-01)", "package_ndc": "53489-676-01", "marketing_start_date": "20130812"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE, PLASTIC (53489-676-03)", "package_ndc": "53489-676-03", "marketing_start_date": "20130812"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (53489-676-05)", "package_ndc": "53489-676-05", "marketing_start_date": "20130812"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (53489-676-06)", "package_ndc": "53489-676-06", "marketing_start_date": "20130812"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (53489-676-07)", "package_ndc": "53489-676-07", "marketing_start_date": "20130812"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (53489-676-10)", "package_ndc": "53489-676-10", "marketing_start_date": "20130812"}], "brand_name": "Phentermine Hydrochloride", "product_id": "53489-676_39e24c57-7266-2bf6-e063-6294a90afdd1", "dosage_form": "TABLET", "pharm_class": ["Appetite Suppression [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic Amine Anorectic [EPC]"], "product_ndc": "53489-676", "dea_schedule": "CIV", "generic_name": "Phentermine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phentermine Hydrochloride", "active_ingredients": [{"name": "PHENTERMINE HYDROCHLORIDE", "strength": "37.5 mg/1"}], "application_number": "ANDA040526", "marketing_category": "ANDA", "marketing_start_date": "20130812", "listing_expiration_date": "20261231"}