diethylpropion hydrochloride er

Generic: diethylpropion hydrochloride

Labeler: omnivium pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diethylpropion hydrochloride er
Generic Name diethylpropion hydrochloride
Labeler omnivium pharmaceuticals llc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diethylpropion hydrochloride 75 mg/1

Manufacturer
OMNIVIUM PHARMACEUTICALS LLC.

Identifiers & Regulatory

Product NDC 81665-109
Product ID 81665-109_487a8d77-bdc6-4b86-8494-2aa87e9c1175
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091680
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-09-19

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 81665109
Hyphenated Format 81665-109

Supplemental Identifiers

RxCUI
978668
UPC
0381665109100
UNII
19V2PL39NG

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 diethylpropion hydrochloride er (source: ndc)
Generic Name diethylpropion hydrochloride (source: ndc)
Application Number ANDA091680 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-10)
  • 250 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-25)
source: ndc

Packages (2)

81665-109-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-10) 81665-109-25 250 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-25)

Ingredients (1)

diethylpropion hydrochloride (75 mg/1)

Linked Drug Pages (1)

Diethylpropion Hydrochloride ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "487a8d77-bdc6-4b86-8494-2aa87e9c1175", "openfda": {"upc": ["0381665109100"], "unii": ["19V2PL39NG"], "rxcui": ["978668"], "spl_set_id": ["cd4f2b19-8752-4fed-81f3-d3074ade613c"], "manufacturer_name": ["OMNIVIUM PHARMACEUTICALS LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-10)", "package_ndc": "81665-109-10", "marketing_start_date": "20250919"}, {"sample": false, "description": "250 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-109-25)", "package_ndc": "81665-109-25", "marketing_start_date": "20250919"}], "brand_name": "Diethylpropion Hydrochloride ER", "product_id": "81665-109_487a8d77-bdc6-4b86-8494-2aa87e9c1175", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Appetite Suppression [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic Amine Anorectic [EPC]"], "product_ndc": "81665-109", "dea_schedule": "CIV", "generic_name": "Diethylpropion Hydrochloride", "labeler_name": "OMNIVIUM PHARMACEUTICALS LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diethylpropion Hydrochloride", "brand_name_suffix": "ER", "active_ingredients": [{"name": "DIETHYLPROPION HYDROCHLORIDE", "strength": "75 mg/1"}], "application_number": "ANDA091680", "marketing_category": "ANDA", "marketing_start_date": "20250919", "listing_expiration_date": "20261231"}