molindone hydrochloride

Generic: molindone hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name molindone hydrochloride
Generic Name molindone hydrochloride
Labeler epic pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

molindone hydrochloride 5 mg/1

Manufacturer
EPIC PHARMA, LLC

Identifiers & Regulatory

Product NDC 42806-336
Product ID 42806-336_d7c8ea49-c06c-441d-820e-def3920f7c1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090453
Listing Expiration 2026-12-31
Marketing Start 2018-10-17

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806336
Hyphenated Format 42806-336

Supplemental Identifiers

RxCUI
1298816 1298906 1298910
UPC
0342806337011
UNII
1DWS68PNE6

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 molindone hydrochloride (source: ndc)
Generic Name molindone hydrochloride (source: ndc)
Application Number ANDA090453 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42806-336-01)
source: ndc

Packages (1)

42806-336-01 100 TABLET in 1 BOTTLE (42806-336-01)

Ingredients (1)

molindone hydrochloride (5 mg/1)

Linked Drug Pages (1)

Molindone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d7c8ea49-c06c-441d-820e-def3920f7c1e", "openfda": {"upc": ["0342806337011"], "unii": ["1DWS68PNE6"], "rxcui": ["1298816", "1298906", "1298910"], "spl_set_id": ["1275e92f-9573-4d0c-8e77-1c9ac47696d2"], "manufacturer_name": ["EPIC PHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42806-336-01)", "package_ndc": "42806-336-01", "marketing_start_date": "20181017"}], "brand_name": "Molindone Hydrochloride", "product_id": "42806-336_d7c8ea49-c06c-441d-820e-def3920f7c1e", "dosage_form": "TABLET", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "42806-336", "generic_name": "Molindone Hydrochloride", "labeler_name": "EPIC PHARMA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Molindone Hydrochloride", "active_ingredients": [{"name": "MOLINDONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090453", "marketing_category": "ANDA", "marketing_start_date": "20181017", "listing_expiration_date": "20261231"}