NDC 71335-0051

GEMFIBROZIL

Gemfibrozil

GEMFIBROZIL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Gemfibrozil.

• Product ID: 71335-0051_13524fb8-b13b-45db-92f8-9420928ec09f
• NDC: 71335-0051
• 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: ANDA078012
• Labeler Name: Bryant Ranch Prepack
• 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: 2021-12-31

Packaging

NDC 71335-0051-1

60 TABLET in 1 BOTTLE (71335-0051-1)

• Marketing Start Date: 2017-10-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71335-0051-2 [71335005102]

GEMFIBROZIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA078012
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-03

NDC 71335-0051-1 [71335005101]

GEMFIBROZIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA078012
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-03

NDC 71335-0051-3 [71335005103]

GEMFIBROZIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA078012
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-03

NDC 71335-0051-5 [71335005105]

GEMFIBROZIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA078012
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-03

NDC 71335-0051-4 [71335005104]

GEMFIBROZIL TABLET

• Marketing Category: ANDA
• Application Number: ANDA078012
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-03

Drug Details

Active Ingredients

Ingredient	Strength
GEMFIBROZIL	600 mg/1

OpenFDA Data

• SPL SET ID: 2cb2de4d-8261-46d8-ae63-c572fdc887d4
• Manufacturer:
  • Bryant Ranch Prepack
• 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