NDC 45802-160

DICLOFENAC SODIUM

Diclofenac Sodium

DICLOFENAC SODIUM is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is Diclofenac Sodium.

• Product ID: 45802-160_00efaeee-c605-46ed-b0f8-c837efc31dc0
• NDC: 45802-160
• Product Type: Human Prescription Drug
• Proprietary Name: DICLOFENAC SODIUM
• Generic Name: Diclofenac Sodium
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-05-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA211253
• Labeler Name: Padagis Israel Pharmaceuticals Ltd
• 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: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 45802-160-00

1 TUBE in 1 CARTON (45802-160-00) > 100 g in 1 TUBE

• Marketing Start Date: 2019-05-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45802-160-00 [45802016000]

DICLOFENAC SODIUM GEL

• Marketing Category: ANDA
• Application Number: ANDA211253
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-05-20

Drug Details

Active Ingredients

Ingredient	Strength
DICLOFENAC SODIUM	10 mg/g

OpenFDA Data

• SPL SET ID: 2087be53-e7a1-48e6-9c54-ab53b44fa572
• Manufacturer:
  • Perrigo New York Inc
• UNII:
  • QTG126297Q

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Decreased Prostaglandin Production [PE]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• 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" or generic name "Diclofenac Sodium"

NDC	Brand Name	Generic Name
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
67544-899	Diclofenac Sodium	Diclofenac Sodium
68001-200	Diclofenac Sodium	Diclofenac Sodium
68001-201	Diclofenac Sodium	Diclofenac Sodium
68001-202	Diclofenac Sodium	Diclofenac Sodium
68001-279	Diclofenac Sodium	Diclofenac Sodium
68001-280	Diclofenac Sodium	Diclofenac Sodium
68001-281	Diclofenac Sodium	Diclofenac Sodium
68071-2045	Diclofenac Sodium	Diclofenac Sodium
68071-3159	Diclofenac sodium	Diclofenac sodium
68071-3325	Diclofenac Sodium	Diclofenac Sodium
68071-3132	Diclofenac Sodium	Diclofenac Sodium
68071-4158	Diclofenac Sodium	Diclofenac Sodium
68071-4382	Diclofenac Sodium	Diclofenac Sodium
68071-4246	Diclofenac sodium	Diclofenac sodium
68084-333	Diclofenac Sodium	Diclofenac Sodium
68151-0849	Diclofenac Sodium	Diclofenac Sodium
68151-2481	Diclofenac Sodium	Diclofenac Sodium
68180-538	Diclofenac Sodium	Diclofenac Sodium
0472-1783	Diclofenac Sodium	Diclofenac Sodium
68387-260	Diclofenac Sodium	Diclofenac Sodium
68382-999	Diclofenac sodium	Diclofenac sodium
68462-355	DICLOFENAC SODIUM	DICLOFENAC SODIUM
68682-103	Diclofenac Sodium	Diclofenac Sodium
68788-7270	Diclofenac Sodium	Diclofenac Sodium
68788-6368	Diclofenac Sodium	Diclofenac Sodium
68788-6388	Diclofenac Sodium	Diclofenac Sodium
68788-6831	Diclofenac sodium	Diclofenac sodium
68788-7225	Diclofenac sodium	Diclofenac sodium
68788-7097	Diclofenac Sodium	Diclofenac Sodium
68788-6952	Diclofenac Sodium	Diclofenac Sodium
68788-9231	Diclofenac Sodium	Diclofenac Sodium
68788-9389	Diclofenac Sodium	Diclofenac Sodium
68788-9523	Diclofenac Sodium	Diclofenac Sodium
68788-9175	Diclofenac Sodium	Diclofenac Sodium
68788-9185	Diclofenac Sodium	Diclofenac Sodium
68788-9435	DICLOFENAC SODIUM	DICLOFENAC SODIUM
69097-524	Diclofenac Sodium	Diclofenac Sodium
0527-2170	Diclofenac Sodium	Diclofenac Sodium
69621-300	Diclofenac Sodium	Diclofenac Sodium
69837-399	DICLOFENAC SODIUM	DICLOFENAC SODIUM