NDC 72578-066

Gemfibrozil

Gemfibrozil

Gemfibrozil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Viona Pharmaceuticals Inc. The primary component is Gemfibrozil.

Product ID72578-066_8a4a73c5-f964-4b82-9524-329d9ec33ce1
NDC72578-066
Product TypeHuman Prescription Drug
Proprietary NameGemfibrozil
Generic NameGemfibrozil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-02-21
Marketing CategoryANDA / ANDA
Application NumberANDA204189
Labeler NameViona Pharmaceuticals Inc
Substance NameGEMFIBROZIL
Active Ingredient Strength600 mg/1
Pharm ClassesPeroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 72578-066-01

100 TABLET in 1 BOTTLE (72578-066-01)
Marketing Start Date2020-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72578-066-05 [72578006605]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-21

NDC 72578-066-14 [72578006614]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-21

NDC 72578-066-16 [72578006616]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-21

NDC 72578-066-01 [72578006601]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-21

NDC 72578-066-30 [72578006630]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-21

NDC 72578-066-77 [72578006677]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-21

NDC 72578-066-06 [72578006606]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-21

NDC 72578-066-10 [72578006610]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA204189
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-21

Drug Details

Active Ingredients

IngredientStrength
GEMFIBROZIL600 mg/1

Pharmacological Class

  • Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
  • PPAR alpha [CS]
  • Peroxisome Proliferator Receptor alpha Agonist [EPC]

NDC Crossover Matching brand name "Gemfibrozil" or generic name "Gemfibrozil"

NDCBrand NameGeneric Name
0093-0670GemfibrozilGemfibrozil
0143-9130GemfibrozilGemfibrozil
0143-9707GemfibrozilGemfibrozil
0179-0221GemfibrozilGemfibrozil
0615-3559GemfibrozilGemfibrozil
0615-8354GemfibrozilGemfibrozil
10544-569GemfibrozilGemfibrozil
16571-784GemfibrozilGemfibrozil
16714-101Gemfibrozilgemfibrozil
21695-732GemfibrozilGemfibrozil
24658-260GemfibrozilGemfibrozil
31722-128GEMFIBROZILGemfibrozil
31722-225GemfibrozilGemfibrozil
33261-146GemfibrozilGemfibrozil
42806-260GEMFIBROZILGEMFIBROZIL
43063-745GemfibrozilGemfibrozil
43063-921GEMFIBROZILGEMFIBROZIL
43353-090GemfibrozilGemfibrozil
43353-772GemfibrozilGemfibrozil
43602-452GEMFIBROZILGemfibrozil
50090-0458GemfibrozilGemfibrozil
50090-2450GemfibrozilGemfibrozil
50090-2902GemfibrozilGemfibrozil
50090-5808GEMFIBROZILGemfibrozil
50268-350GemfibrozilGemfibrozil
68071-1733GemfibrozilGemfibrozil
68071-4053GEMFIBROZILGEMFIBROZIL
68071-4011GEMFIBROZILGEMFIBROZIL
68071-4631GemfibrozilGemfibrozil
68071-4421GemfibrozilGemfibrozil
68151-2893GemfibrozilGemfibrozil
68382-553GemfibrozilGemfibrozil
68788-6447GemfibrozilGemfibrozil
68788-7011GEMFIBROZILGEMFIBROZIL
68788-9149GemfibrozilGemfibrozil
69097-821GemfibrozilGemfibrozil
70518-1563GemfibrozilGemfibrozil
70518-1301GemfibrozilGemfibrozil
70771-1431GemfibrozilGemfibrozil
71205-169GemfibrozilGemfibrozil
71209-008GemfibrozilGemfibrozil
71335-0051GEMFIBROZILGEMFIBROZIL
71335-0971GemfibrozilGemfibrozil
71335-0899GemfibrozilGemfibrozil
71335-0515GemfibrozilGemfibrozil
71610-200GemfibrozilGemfibrozil
71610-107GemfibrozilGemfibrozil
75834-131GemfibrozilGemfibrozil
76282-225GemfibrozilGemfibrozil
50436-6540GemfibrozilGemfibrozil
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