NDC 68071-4053

GEMFIBROZIL

Gemfibrozil

GEMFIBROZIL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Gemfibrozil.

• Product ID: 68071-4053_56e33071-420b-2039-e054-00144ff88e88
• NDC: 68071-4053
• Product Type: Human Prescription Drug
• Proprietary Name: GEMFIBROZIL
• Generic Name: Gemfibrozil
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-03-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077836
• Labeler Name: NuCare Pharmaceuticals,Inc.
• Substance Name: GEMFIBROZIL
• Active Ingredient Strength: 600 mg/1
• Pharm Classes: Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68071-4053-1

100 TABLET in 1 BOTTLE (68071-4053-1)

• Marketing Start Date: 2017-08-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68071-4053-9 [68071405309]

GEMFIBROZIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA077836
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-16
• Inactivation Date: 2020-01-31

NDC 68071-4053-6 [68071405306]

GEMFIBROZIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA077836
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-16
• Inactivation Date: 2020-01-31

NDC 68071-4053-3 [68071405303]

GEMFIBROZIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA077836
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-16
• Inactivation Date: 2020-01-31

NDC 68071-4053-1 [68071405301]

GEMFIBROZIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA077836
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-16
• Inactivation Date: 2020-01-31

NDC 68071-4053-2 [68071405302]

GEMFIBROZIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA077836
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-16
• Inactivation Date: 2020-01-31

NDC 68071-4053-8 [68071405308]

GEMFIBROZIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA077836
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-16
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
GEMFIBROZIL	600 mg/1

OpenFDA Data

• SPL SET ID: 56e33071-420a-2039-e054-00144ff88e88
• Manufacturer:
  • NuCare Pharmaceuticals,Inc.
• UNII:
  • Q8X02027X3
• RxNorm Concept Unique ID - RxCUI:
  • 310459

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"

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