phentermine and topiramate

Generic: phentermine and topiramate

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name phentermine and topiramate
Generic Name phentermine and topiramate
Labeler prasco laboratories
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

phentermine hydrochloride 7.5 mg/1, topiramate 46 mg/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-781
Product ID 66993-781_3661f243-9a4f-7c78-e063-6294a90abe4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022580
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 66993781
Hyphenated Format 66993-781

Supplemental Identifiers

RxCUI
1302827 1302839 1302850 1313059
UPC
0366993783307 0366993782300 0366993781303 0366993780306
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 (source: ndc)
Generic Name phentermine and topiramate (source: ndc)
Application Number NDA022580 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
  • 46 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (66993-781-30)
source: ndc

Packages (1)

66993-781-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (66993-781-30)

Ingredients (2)

phentermine hydrochloride (7.5 mg/1) topiramate (46 mg/1)

Linked Drug Pages (1)

phentermine and topiramate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3661f243-9a4f-7c78-e063-6294a90abe4a", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0366993783307", "0366993782300", "0366993781303", "0366993780306"], "unii": ["0K2I505OTV", "0H73WJJ391"], "rxcui": ["1302827", "1302839", "1302850", "1313059"], "spl_set_id": ["876bd763-13fa-481e-b579-c2fc44dbf3c2"], "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": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (66993-781-30)", "package_ndc": "66993-781-30", "marketing_start_date": "20250601"}], "brand_name": "phentermine and topiramate", "product_id": "66993-781_3661f243-9a4f-7c78-e063-6294a90abe4a", "dosage_form": "CAPSULE, EXTENDED RELEASE", "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": "66993-781", "dea_schedule": "CIV", "generic_name": "phentermine and topiramate", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "phentermine and topiramate", "active_ingredients": [{"name": "PHENTERMINE HYDROCHLORIDE", "strength": "7.5 mg/1"}, {"name": "TOPIRAMATE", "strength": "46 mg/1"}], "application_number": "NDA022580", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}