NDC 0378-8750

Diclofenac Sodium

Diclofenac

Diclofenac Sodium is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Diclofenac Sodium.

Product ID0378-8750_585549fe-dca3-47cb-a454-7a3b42fa8443
NDC0378-8750
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium
Generic NameDiclofenac
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2019-05-06
Marketing CategoryANDA / ANDA
Application NumberANDA204306
Labeler NameMylan Pharmaceuticals Inc.
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength10 mg/g
Pharm ClassesCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-8750-06

1 TUBE in 1 CARTON (0378-8750-06) > 100 g in 1 TUBE
Marketing Start Date2019-05-06
Marketing End Date2022-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-8750-06 [00378875006]

Diclofenac Sodium GEL
Marketing CategoryANDA
Application NumberANDA204306
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-05-06

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM10 mg/g

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"

NDCBrand NameGeneric Name
0115-1483Diclofenac SodiumDiclofenac Sodium
0168-0803DICLOFENAC SODIUMdiclofenac sodium
0168-0844DICLOFENAC SODIUMdiclofenac sodium
0228-2550Diclofenac SodiumDiclofenac Sodium
0228-2551Diclofenac SodiumDiclofenac Sodium
0363-1210Diclofenac sodiumDiclofenac sodium
0363-1871diclofenac sodiumdiclofenac sodium
0378-0355Diclofenac SodiumDiclofenac Sodium
0378-6280Diclofenac Sodiumdiclofenac sodium
0378-6281Diclofenac Sodiumdiclofenac sodium
67544-899Diclofenac SodiumDiclofenac Sodium
68001-200Diclofenac SodiumDiclofenac Sodium
68001-201Diclofenac SodiumDiclofenac Sodium
68001-202Diclofenac SodiumDiclofenac Sodium
68001-279Diclofenac SodiumDiclofenac Sodium
68001-280Diclofenac SodiumDiclofenac Sodium
68001-281Diclofenac SodiumDiclofenac Sodium
68071-2045Diclofenac SodiumDiclofenac Sodium
68071-3159Diclofenac sodiumDiclofenac sodium
68071-3325Diclofenac SodiumDiclofenac Sodium
68071-3132Diclofenac SodiumDiclofenac Sodium
68071-4158Diclofenac SodiumDiclofenac Sodium
68071-4382Diclofenac SodiumDiclofenac Sodium
68071-4246Diclofenac sodiumDiclofenac sodium
68084-333Diclofenac SodiumDiclofenac Sodium
68151-0849Diclofenac SodiumDiclofenac Sodium
68151-2481Diclofenac SodiumDiclofenac Sodium
68180-538Diclofenac SodiumDiclofenac Sodium
0472-1783Diclofenac SodiumDiclofenac Sodium
68387-260Diclofenac SodiumDiclofenac Sodium
68382-999Diclofenac sodiumDiclofenac sodium
68462-355DICLOFENAC SODIUMDICLOFENAC SODIUM
68682-103Diclofenac SodiumDiclofenac Sodium
68788-7270Diclofenac SodiumDiclofenac Sodium
68788-6368Diclofenac SodiumDiclofenac Sodium
68788-6388Diclofenac SodiumDiclofenac Sodium
68788-6831Diclofenac sodiumDiclofenac sodium
68788-7225Diclofenac sodiumDiclofenac sodium
68788-7097Diclofenac SodiumDiclofenac Sodium
68788-6952Diclofenac SodiumDiclofenac Sodium
68788-9231Diclofenac SodiumDiclofenac Sodium
68788-9389Diclofenac SodiumDiclofenac Sodium
68788-9523Diclofenac SodiumDiclofenac Sodium
68788-9175Diclofenac SodiumDiclofenac Sodium
68788-9185Diclofenac SodiumDiclofenac Sodium
68788-9435DICLOFENAC SODIUMDICLOFENAC SODIUM
69097-524Diclofenac SodiumDiclofenac Sodium
0527-2170Diclofenac SodiumDiclofenac Sodium
69621-300Diclofenac SodiumDiclofenac Sodium
69837-399DICLOFENAC SODIUMDICLOFENAC SODIUM

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