tolmetin sodium

Generic: tolmetin sodium

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tolmetin sodium
Generic Name tolmetin sodium
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tolmetin sodium 600 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-825
Product ID 16571-825_ff84bf16-f778-489c-9cb0-c6df96b5b56d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074473
Marketing Start 2023-04-11
Marketing End 2026-05-31

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 16571825
Hyphenated Format 16571-825

Supplemental Identifiers

RxCUI
198297
UPC
0316571825097
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 tolmetin sodium (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
  • 90 TABLET, FILM COATED in 1 BOTTLE (16571-825-09)
source: ndc

Packages (1)

16571-825-09 90 TABLET, FILM COATED in 1 BOTTLE (16571-825-09)

Ingredients (1)

tolmetin sodium (600 mg/1)

Linked Drug Pages (1)

TOLMETIN SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ff84bf16-f778-489c-9cb0-c6df96b5b56d", "openfda": {"upc": ["0316571825097"], "unii": ["02N1TZF99F"], "rxcui": ["198297"], "spl_set_id": ["fa4096f0-0d22-4421-b4ca-6b1d7f078bd3"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16571-825-09)", "package_ndc": "16571-825-09", "marketing_end_date": "20260531", "marketing_start_date": "20230411"}], "brand_name": "TOLMETIN SODIUM", "product_id": "16571-825_ff84bf16-f778-489c-9cb0-c6df96b5b56d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "16571-825", "generic_name": "tolmetin sodium", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOLMETIN SODIUM", "active_ingredients": [{"name": "TOLMETIN SODIUM", "strength": "600 mg/1"}], "application_number": "ANDA074473", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20230411"}