NDC 35356-554

Diclofenac

Diclofenac Sodium

Diclofenac is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Diclofenac Sodium.

• Product ID: 35356-554_6faa24bc-3dee-4fb1-8b8f-6737c0547464
• NDC: 35356-554
• Product Type: Human Prescription Drug
• Proprietary Name: Diclofenac
• Generic Name: Diclofenac Sodium
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2008-05-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077845
• Labeler Name: Lake Erie Medical DBA Quality Care Products LLC
• Substance Name: DICLOFENAC SODIUM
• Active Ingredient Strength: 1 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: 2019-12-31

Packaging

NDC 35356-554-05

1 BOTTLE, DROPPER in 1 CARTON (35356-554-05) > 2.5 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2013-01-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 35356-554-05 [35356055405]

Diclofenac SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA077845
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-01-31
• Marketing End Date: 2019-10-11

Drug Details

Active Ingredients

Ingredient	Strength
DICLOFENAC SODIUM	1 mg/mL

OpenFDA Data

• SPL SET ID: 980b3b80-44cb-44b5-89cc-d451a3b20ae3
• Manufacturer:
  • Lake Erie Medical DBA Quality Care Products LLC
• UNII:
  • QTG126297Q
• RxNorm Concept Unique ID - RxCUI:
  • 854801

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" or generic name "Diclofenac Sodium"

NDC	Brand Name	Generic Name
17478-892	Diclofenac	Diclofenac
35356-554	Diclofenac	Diclofenac
50090-0641	Diclofenac	Diclofenac
59390-149	Diclofenac	Diclofenac
73480-242	DICLOFENAC	DICLOFENAC
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