NDC 61919-592

VOLTAREN

Voltaren

VOLTAREN is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Diclofenac Sodium.

• Product ID: 61919-592_9441684a-4941-406f-a4a3-c9d996285bd3
• NDC: 61919-592
• Product Type: Human Prescription Drug
• Proprietary Name: VOLTAREN
• Generic Name: Voltaren
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA022122
• Labeler Name: DIRECT RX
• 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 61919-592-01

100 g in 1 TUBE (61919-592-01)

• Marketing Start Date: 2015-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-592-01 [61919059201]

VOLTAREN GEL

• Marketing Category: NDA
• Application Number: NDA022122
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2015-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DICLOFENAC SODIUM	10 mg/g

OpenFDA Data

• SPL SET ID: b04009ca-7545-4cd4-af63-f15aebf20f18
• Manufacturer:
  • DIRECT RX
• UNII:
  • QTG126297Q
• RxNorm Concept Unique ID - RxCUI:
  • 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 "Voltaren"

NDC	Brand Name	Generic Name
0067-8152	Voltaren	diclofenac sodium
0067-8153	Voltaren	diclofenac sodium
0078-0478	VOLTAREN	diclofenac sodium
21695-791	Voltaren	diclofenac sodium
35356-187	Voltaren	diclofenac sodium
50090-1099	Voltaren	diclofenac sodium
50436-3621	Voltaren	diclofenac sodium
61919-060	VOLTAREN	DICLOFENAC SODIUM D/R
61919-592	VOLTAREN	VOLTAREN
63187-582	Voltaren	diclofenac sodium
63481-684	Voltaren	diclofenac sodium
63629-4941	Voltaren	diclofenac sodium
68387-456	Voltaren	diclofenac sodium
68788-9338	Voltaren	diclofenac sodium
70518-1578	Voltaren	diclofenac sodium
80425-0055	Voltaren	Diclofenac Sodium 75mg
80425-0056	Voltaren	Diclofenac Sodium 75mg
80425-0102	Voltaren	Diclofenac Sodium 50mg