NDC 0378-0313

Tolmetin Sodium

Tolmetin Sodium

Tolmetin Sodium is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Tolmetin Sodium.

• Product ID: 0378-0313_71d198cb-78bf-4564-aae5-b7cde7913521
• NDC: 0378-0313
• Product Type: Human Prescription Drug
• Proprietary Name: Tolmetin Sodium
• Generic Name: Tolmetin Sodium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1994-08-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074473
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: TOLMETIN SODIUM
• Active Ingredient Strength: 600 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0378-0313-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0313-01)

• Marketing Start Date: 1994-08-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0313-01 [00378031301]

Tolmetin Sodium TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA074473
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1994-08-30

Drug Details

Active Ingredients

Ingredient	Strength
TOLMETIN SODIUM	600 mg/1

OpenFDA Data

• SPL SET ID: 6e0228a8-e3d3-4ae9-8873-d7aa3e0dcfee
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 02N1TZF99F
• RxNorm Concept Unique ID - RxCUI:
  • 198297

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Cyclooxygenase Inhibitors [MoA]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]

NDC Crossover Matching brand name "Tolmetin Sodium" or generic name "Tolmetin Sodium"

NDC	Brand Name	Generic Name
0378-0313	Tolmetin Sodium	tolmetin sodium
0378-5200	Tolmetin Sodium	tolmetin Sodium
53489-506	TOLMETIN SODIUM	tolmetin sodium
53489-507	TOLMETIN SODIUM	tolmetin sodium