diethylpropion hydrochloride er

Generic: diethylpropion hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diethylpropion hydrochloride er
Generic Name diethylpropion hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

diethylpropion hydrochloride 75 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-532
Product ID 43063-532_413931e3-aacb-4898-e063-6294a90a5b6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091680
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2011-10-24

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 43063532
Hyphenated Format 43063-532

Supplemental Identifiers

RxCUI
978668
UPC
0343063532072
UNII
19V2PL39NG

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
  • 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-07)
  • 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-14)
  • 21 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-21)
  • 28 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-28)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-30)
source: ndc

Packages (5)

43063-532-07 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-07) 43063-532-14 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-14) 43063-532-21 21 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-21) 43063-532-28 28 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-28) 43063-532-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-30)

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": "413931e3-aacb-4898-e063-6294a90a5b6b", "openfda": {"upc": ["0343063532072"], "unii": ["19V2PL39NG"], "rxcui": ["978668"], "spl_set_id": ["0d213a24-ebbf-41df-8f32-de44a572829e"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-07)", "package_ndc": "43063-532-07", "marketing_start_date": "20140630"}, {"sample": false, "description": "14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-14)", "package_ndc": "43063-532-14", "marketing_start_date": "20140630"}, {"sample": false, "description": "21 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-21)", "package_ndc": "43063-532-21", "marketing_start_date": "20171219"}, {"sample": false, "description": "28 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-28)", "package_ndc": "43063-532-28", "marketing_start_date": "20161114"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-30)", "package_ndc": "43063-532-30", "marketing_start_date": "20140725"}], "brand_name": "Diethylpropion Hydrochloride ER", "product_id": "43063-532_413931e3-aacb-4898-e063-6294a90a5b6b", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Appetite Suppression [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic Amine Anorectic [EPC]"], "product_ndc": "43063-532", "dea_schedule": "CIV", "generic_name": "Diethylpropion Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20111024", "listing_expiration_date": "20261231"}