NDC 75854-801

Gloperba

Colchicine

Gloperba is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Avion Pharmaceuticals, Llc. The primary component is Colchicine.

Product ID75854-801_8f9ba661-b7ab-11fc-e053-2995a90a0bd1
NDC75854-801
Product TypeHuman Prescription Drug
Proprietary NameGloperba
Generic NameColchicine
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-08-01
Marketing CategoryNDA / NDA
Application NumberNDA210942
Labeler NameAvion Pharmaceuticals, LLC
Substance NameCOLCHICINE
Active Ingredient Strength1 mg/5mL
Pharm ClassesCytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 75854-801-01

150 mL in 1 BOTTLE, PLASTIC (75854-801-01)
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 75854-801-01 [75854080101]

Gloperba SOLUTION
Marketing CategoryNDA
Application NumberNDA210942
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
COLCHICINE.6 mg/5mL

OpenFDA Data

SPL SET ID:8f9ba661-b7aa-11fc-e053-2995a90a0bd1
Manufacturer
UNII

Pharmacological Class

  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Interactions [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Interactions [MoA]

NDC Crossover Matching brand name "Gloperba" or generic name "Colchicine"

NDCBrand NameGeneric Name
75854-801GloperbaGloperba
72690-010GloperbaGloperba
0143-3018ColchicineColchicine
0254-2008ColchicineColchicine
0378-1086ColchicineColchicine
0591-2562ColchicineColchicine
0904-6732ColchicineColchicine
0904-7120ColchicineColchicine
16714-039ColchicineColchicine
31722-899ColchicineColchicine
42292-054ColchicineColchicine
43598-372colchicinecolchicine
49884-171Colchicinecolchicine
50090-3465ColchicineColchicine
50268-187ColchicineColchicine
51407-082ColchicineColchicine
59651-455ColchicineColchicine
60687-358ColchicineColchicine
60687-389ColchicineColchicine
13310-119ColcrysColchicine
43353-854ColcrysColchicine
63187-292ColcrysColchicine
59467-318MITIGAREColchicine

Trademark Results [Gloperba]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GLOPERBA
GLOPERBA
98273093 not registered Live/Pending
RxOMEG Therapeutics LLC
2023-11-16
GLOPERBA
GLOPERBA
86871218 5219373 Live/Registered
RxOMEG Therapeutics LLC
2016-01-11
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