NDC 71205-138

Diclofenac Sodium 1.5%

Diclofenac Sodium Topical Solution

Diclofenac Sodium 1.5% is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Diclofenac Sodium.

• Product ID: 71205-138_63bfe948-54f0-47fc-904a-c5665fc2f43c
• NDC: 71205-138
• Product Type: Human Prescription Drug
• Proprietary Name: Diclofenac Sodium 1.5%
• Generic Name: Diclofenac Sodium Topical Solution
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-11-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202769
• Labeler Name: Proficient Rx LP
• 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: 2020-12-31

Packaging

NDC 71205-138-15

150 mL in 1 BOTTLE (71205-138-15)

• Marketing Start Date: 2018-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71205-138-15 [71205013815]

Diclofenac Sodium 1.5% SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202769
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-01

Drug Details

Active Ingredients

Ingredient	Strength
DICLOFENAC SODIUM	16.05 mg/mL

OpenFDA Data

• SPL SET ID: ac82c08f-a2e9-433c-92ea-bef724169f20
• Manufacturer:
  • Proficient Rx LP
• 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]

NDC Crossover Matching brand name "Diclofenac Sodium 1.5%" or generic name "Diclofenac Sodium Topical Solution"

NDC	Brand Name	Generic Name
50436-2225	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical
50436-3338	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical
55700-878	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical Solution
55700-931	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical
68788-7701	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical Solution
68788-8084	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical
70512-025	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical Solution
70512-038	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical
71205-138	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical Solution
71205-640	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical