NDC 0378-5200

Tolmetin Sodium

Tolmetin Sodium

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

• Product ID: 0378-5200_19eb489c-d59b-4060-8e31-ed114477f5c2
• NDC: 0378-5200
• Product Type: Human Prescription Drug
• Proprietary Name: Tolmetin Sodium
• Generic Name: Tolmetin Sodium
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1993-05-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA073393
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: TOLMETIN SODIUM
• Active Ingredient Strength: 400 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 0378-5200-01

100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5200-01)

• Marketing Start Date: 1993-05-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-5200-01 [00378520001]

Tolmetin Sodium CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA073393
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1993-05-27

Drug Details

Active Ingredients

Ingredient	Strength
TOLMETIN SODIUM	400 mg/1

OpenFDA Data

• SPL SET ID: dbae03d7-b6ab-4139-8e79-29c05924849e
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 02N1TZF99F
• RxNorm Concept Unique ID - RxCUI:
  • 198296

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