tolectin

Generic: tolmetin sodium

Labeler: poly pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolectin
Generic Name tolmetin sodium
Labeler poly pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tolmetin sodium 600 mg/1

Manufacturer
Poly Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50991-988
Product ID 50991-988_472dd96d-50bb-e82c-e063-6294a90af66d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074473
Listing Expiration 2026-12-31
Marketing Start 2024-04-04

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50991988
Hyphenated Format 50991-988

Supplemental Identifiers

RxCUI
198297 208048
UPC
0350991988307
UNII
02N1TZF99F

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 tolectin (source: ndc)
Generic Name tolmetin sodium (source: ndc)
Application Number ANDA074473 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50991-988-30)
source: ndc

Packages (1)

50991-988-30 30 TABLET, FILM COATED in 1 BOTTLE (50991-988-30)

Ingredients (1)

tolmetin sodium (600 mg/1)

Linked Drug Pages (1)

Tolectin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "472dd96d-50bb-e82c-e063-6294a90af66d", "openfda": {"upc": ["0350991988307"], "unii": ["02N1TZF99F"], "rxcui": ["198297", "208048"], "spl_set_id": ["15467b19-e43a-5be9-e063-6294a90a3cca"], "manufacturer_name": ["Poly Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50991-988-30)", "package_ndc": "50991-988-30", "marketing_start_date": "20240404"}], "brand_name": "Tolectin", "product_id": "50991-988_472dd96d-50bb-e82c-e063-6294a90af66d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50991-988", "generic_name": "tolmetin sodium", "labeler_name": "Poly Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tolectin", "active_ingredients": [{"name": "TOLMETIN SODIUM", "strength": "600 mg/1"}], "application_number": "ANDA074473", "marketing_category": "ANDA", "marketing_start_date": "20240404", "listing_expiration_date": "20261231"}