NDC 68387-456

Voltaren

Diclofenac Sodium

Voltaren is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Keltman Pharmaceuticals Inc.. The primary component is Diclofenac Sodium.

• Product ID: 68387-456_9c160477-60c6-4f71-9269-48432b6799f1
• NDC: 68387-456
• Product Type: Human Prescription Drug
• Proprietary Name: Voltaren
• Generic Name: Diclofenac Sodium
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-01-27
• Marketing Category: NDA / NDA
• Application Number: NDA022122
• Labeler Name: Keltman Pharmaceuticals Inc.
• Substance Name: DICLOFENAC SODIUM
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68387-456-01

1 TUBE in 1 CARTON (68387-456-01) > 100 g in 1 TUBE

• Marketing Start Date: 2011-01-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68387-456-01 [68387045601]

Voltaren GEL

• Marketing Category: NDA
• Application Number: NDA022122
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2011-01-27
• Inactivation Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
DICLOFENAC SODIUM	10 mg/g

OpenFDA Data

• SPL SET ID: 26b2d99e-d471-4758-8aa0-a26ef464eb35
• Manufacturer:
  • Keltman Pharmaceuticals Inc.
• UNII:
  • QTG126297Q
• RxNorm Concept Unique ID - RxCUI:
  • 855635
  • 855633

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Decreased Prostaglandin Production [PE]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]

NDC Crossover Matching brand name "Voltaren" or generic name "Diclofenac Sodium"

NDC	Brand Name	Generic Name
0067-8152	Voltaren	diclofenac sodium
0067-8153	Voltaren	diclofenac sodium
0078-0478	VOLTAREN	diclofenac sodium
68387-456	Voltaren	Voltaren
68788-9338	Voltaren	Voltaren
70518-1578	Voltaren	Voltaren
21695-791	Voltaren	Voltaren
35356-187	Voltaren	Voltaren
50090-1099	Voltaren	Voltaren
50436-3621	Voltaren	Voltaren
61919-592	VOLTAREN	VOLTAREN
63481-684	Voltaren	Voltaren
63187-582	Voltaren	Voltaren
63629-4941	Voltaren	Voltaren
61919-060	VOLTAREN	VOLTAREN
80425-0055	Voltaren	Voltaren
80425-0102	Voltaren	Voltaren
80425-0056	Voltaren	Voltaren
0280-0039	Aleve Arthritis Pain Gel	Diclofenac Sodium
0115-1483	Diclofenac Sodium	Diclofenac Sodium
0168-0803	DICLOFENAC SODIUM	diclofenac sodium
0168-0844	DICLOFENAC SODIUM	diclofenac sodium
0228-2550	Diclofenac Sodium	Diclofenac Sodium
0228-2551	Diclofenac Sodium	Diclofenac Sodium
0363-1210	Diclofenac sodium	Diclofenac sodium
0363-1871	diclofenac sodium	diclofenac sodium
0378-0355	Diclofenac Sodium	Diclofenac Sodium
0378-6280	Diclofenac Sodium	diclofenac sodium
0378-6281	Diclofenac Sodium	diclofenac sodium
0113-1189	good sense arthritis pain	diclofenac sodium