NDC 50742-308

Diclofenac Sodium Topical Solution

Diclofenac Sodium

Diclofenac Sodium Topical Solution is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Diclofenac Sodium.

• Product ID: 50742-308_756c475b-2023-496b-b1db-6a2a4c69e46e
• NDC: 50742-308
• Product Type: Human Prescription Drug
• Proprietary Name: Diclofenac Sodium Topical Solution
• Generic Name: Diclofenac Sodium
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-11-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206715
• Labeler Name: Ingenus Pharmaceuticals, LLC
• Substance Name: DICLOFENAC SODIUM
• Active Ingredient Strength: 16 mg/mL
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50742-308-05

1 BOTTLE, DROPPER in 1 CARTON (50742-308-05) > 150 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2017-11-01
• Marketing End Date: 2021-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50742-308-05 [50742030805]

Diclofenac Sodium Topical Solution SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA206715
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-11-01

Drug Details

Active Ingredients

Ingredient	Strength
DICLOFENAC SODIUM	16.05 mg/mL

OpenFDA Data

• SPL SET ID: 738244f8-7715-40f2-a6b4-1e4d91710043
• Manufacturer:
  • Ingenus Pharmaceuticals, LLC
• UNII:
  • QTG126297Q
• RxNorm Concept Unique ID - RxCUI:
  • 857700

Pharmacological Class

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

Medicade Reported Pricing

50742030805 DICLOFENAC 1.5% TOPICAL SOLN

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Diclofenac Sodium Topical Solution" or generic name "Diclofenac Sodium"

NDC	Brand Name	Generic Name
68788-7151	Diclofenac Sodium Topical Solution	Diclofenac Sodium Topical Solution
50742-308	Diclofenac Sodium Topical Solution	Diclofenac Sodium Topical Solution
45865-983	Diclofenac Sodium Topical Solution	Diclofenac Sodium Topical Solution
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
0067-8152	Voltaren	diclofenac sodium
0067-8153	Voltaren	diclofenac sodium
0078-0478	VOLTAREN	diclofenac sodium