phendimetrazine tartrate

Generic: phendimetrazine tartrate

Labeler: elite laboratories, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phendimetrazine tartrate
Generic Name phendimetrazine tartrate
Labeler elite laboratories, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

phendimetrazine tartrate 35 mg/1

Manufacturer
Elite Laboratories, Inc

Identifiers & Regulatory

Product NDC 64850-440
Product ID 64850-440_97b69c02-a69e-46fe-8686-4b4d8ceb5dca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040762
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2012-11-20

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 64850440
Hyphenated Format 64850-440

Supplemental Identifiers

RxCUI
979549
UPC
0364850440011 0364850440103
UNII
6985IP0T80

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 phendimetrazine tartrate (source: ndc)
Generic Name phendimetrazine tartrate (source: ndc)
Application Number ANDA040762 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 35 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64850-440-01)
  • 1000 TABLET in 1 BOTTLE (64850-440-10)
source: ndc

Packages (2)

64850-440-01 100 TABLET in 1 BOTTLE (64850-440-01) 64850-440-10 1000 TABLET in 1 BOTTLE (64850-440-10)

Ingredients (1)

phendimetrazine tartrate (35 mg/1)

Linked Drug Pages (1)

PHENDIMETRAZINE TARTRATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "97b69c02-a69e-46fe-8686-4b4d8ceb5dca", "openfda": {"upc": ["0364850440011", "0364850440103"], "unii": ["6985IP0T80"], "rxcui": ["979549"], "spl_set_id": ["42ecacde-6859-47c6-ba44-13fb4f3b5448"], "manufacturer_name": ["Elite Laboratories, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64850-440-01)", "package_ndc": "64850-440-01", "marketing_start_date": "20121120"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (64850-440-10)", "package_ndc": "64850-440-10", "marketing_start_date": "20121120"}], "brand_name": "PHENDIMETRAZINE TARTRATE", "product_id": "64850-440_97b69c02-a69e-46fe-8686-4b4d8ceb5dca", "dosage_form": "TABLET", "pharm_class": ["Appetite Suppression [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic Amine Anorectic [EPC]"], "product_ndc": "64850-440", "dea_schedule": "CIII", "generic_name": "Phendimetrazine Tartrate", "labeler_name": "Elite Laboratories, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENDIMETRAZINE TARTRATE", "active_ingredients": [{"name": "PHENDIMETRAZINE TARTRATE", "strength": "35 mg/1"}], "application_number": "ANDA040762", "marketing_category": "ANDA", "marketing_start_date": "20121120", "listing_expiration_date": "20261231"}