NDC 50436-3338

Diclofenac Sodium 1.5%

Diclofenac Sodium Topical

Diclofenac Sodium 1.5% is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Unit Dose Services. The primary component is Diclofenac Sodium.

Product ID50436-3338_09544567-99d6-4d06-bc89-6929746157ee
NDC50436-3338
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium 1.5%
Generic NameDiclofenac Sodium Topical
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2021-06-04
Marketing CategoryANDA /
Application NumberANDA204132
Labeler NameUnit Dose Services
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength16 mg/mL
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50436-3338-1

150 mL in 1 BOTTLE (50436-3338-1)
Marketing Start Date2021-12-15
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
50436-2225Diclofenac Sodium 1.5%Diclofenac Sodium Topical
50436-3338Diclofenac Sodium 1.5%Diclofenac Sodium Topical
55700-878Diclofenac Sodium 1.5%Diclofenac Sodium Topical Solution
55700-931Diclofenac Sodium 1.5%Diclofenac Sodium Topical
68788-7701Diclofenac Sodium 1.5%Diclofenac Sodium Topical Solution
68788-8084Diclofenac Sodium 1.5%Diclofenac Sodium Topical
70512-025Diclofenac Sodium 1.5%Diclofenac Sodium Topical Solution
70512-038Diclofenac Sodium 1.5%Diclofenac Sodium Topical
71205-138Diclofenac Sodium 1.5%Diclofenac Sodium Topical Solution
71205-640Diclofenac Sodium 1.5%Diclofenac Sodium Topical
62332-581Diclofenac SodiumDiclofenac Sodium Topical

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