NDC 70518-1563

Gemfibrozil

Gemfibrozil

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

Product ID70518-1563_78eeaed0-e1ab-d08c-e053-2991aa0a511f
NDC70518-1563
Product TypeHuman Prescription Drug
Proprietary NameGemfibrozil
Generic NameGemfibrozil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-10-22
Marketing CategoryANDA / ANDA
Application NumberANDA077836
Labeler NameREMEDYREPACK INC.
Substance NameGEMFIBROZIL
Active Ingredient Strength600 mg/1
Pharm ClassesPeroxisome Prol
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1563-0

45 TABLET in 1 BOTTLE, PLASTIC (70518-1563-0)
Marketing Start Date2018-10-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1563-1 [70518156301]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA077836
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-23

NDC 70518-1563-3 [70518156303]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA077836
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-11

NDC 70518-1563-0 [70518156300]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA077836
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-22

NDC 70518-1563-2 [70518156302]

Gemfibrozil TABLET
Marketing CategoryANDA
Application NumberANDA077836
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-03

Drug Details

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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