phentermine and topiramate extended-release (43598-627)

Drug Facts

Product Profile

Brand Name phentermine and topiramate extended-release

Generic Name phentermine and topiramate extended-release

Labeler dr.reddys laboratories inc

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

phentermine hydrochloride 15 mg/1, topiramate 92 mg/1

Manufacturer

Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-627

Product ID 43598-627_67155108-ea36-1f02-9acd-46329845e85c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208175

DEA Schedule civ

Listing Expiration 2026-12-31

Marketing Start 2025-06-01

Pharmacologic Class

Mechanism of Action

cytochrome p450 3a4 inducers [moa] cytochrome p450 2c19 inhibitors [moa]

Physiologic Effect

decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598627

Hyphenated Format 43598-627

Supplemental Identifiers

RxCUI

1302827 1302839 1302850 1313059

UPC

0343598626307 0343598624303 0343598625300

UNII

0K2I505OTV 0H73WJJ391

NUI

N0000008486 N0000185506 N0000182140

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 and topiramate extended-release (source: ndc)

Generic Name phentermine and topiramate extended-release (source: ndc)

Application Number ANDA208175 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

15 mg/1
92 mg/1

source: ndc

Packaging

30 CAPSULE in 1 BOTTLE (43598-627-30)

source: ndc

Packages (1)

43598-627-30 30 CAPSULE in 1 BOTTLE (43598-627-30)

Ingredients (2)

phentermine hydrochloride (15 mg/1) topiramate (92 mg/1)

Linked Drug Pages (1)

Phentermine and Topiramate Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "67155108-ea36-1f02-9acd-46329845e85c", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0343598626307", "0343598624303", "0343598625300"], "unii": ["0K2I505OTV", "0H73WJJ391"], "rxcui": ["1302827", "1302839", "1302850", "1313059"], "spl_set_id": ["260c3f90-163d-0bdd-1099-55d18a900e68"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (43598-627-30)", "package_ndc": "43598-627-30", "marketing_start_date": "20250601"}], "brand_name": "Phentermine and Topiramate Extended-Release", "product_id": "43598-627_67155108-ea36-1f02-9acd-46329845e85c", "dosage_form": "CAPSULE", "pharm_class": ["Appetite Suppression [PE]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic Amine Anorectic [EPC]"], "product_ndc": "43598-627", "dea_schedule": "CIV", "generic_name": "Phentermine and Topiramate Extended-Release", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phentermine and Topiramate Extended-Release", "active_ingredients": [{"name": "PHENTERMINE HYDROCHLORIDE", "strength": "15 mg/1"}, {"name": "TOPIRAMATE", "strength": "92 mg/1"}], "application_number": "ANDA208175", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}