NDC 0378-3123

Repaglinide

Repaglinide

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

• Product ID: 0378-3123_982ba2c2-0ba7-47f4-ad30-51788f52e634
• NDC: 0378-3123
• Product Type: Human Prescription Drug
• Proprietary Name: Repaglinide
• Generic Name: Repaglinide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-01-22
• Marketing End Date: 2019-06-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090252
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: REPAGLINIDE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Glinide [EPC],Potassium Channel Antagonists [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0378-3123-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-3123-01)

• Marketing Start Date: 2014-01-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-3123-01 [00378312301]

Repaglinide TABLET

• Marketing Category: ANDA
• Application Number: ANDA090252
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-01-22
• Marketing End Date: 2019-06-30

NDC 0378-3123-05 [00378312305]

Repaglinide TABLET

• Marketing Category: ANDA
• Application Number: ANDA090252
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-01-22
• Marketing End Date: 2017-03-29

Drug Details

Active Ingredients

Ingredient	Strength
REPAGLINIDE	2 mg/1

OpenFDA Data

• SPL SET ID: 45422d96-1673-4419-bdb2-d127bb67fabc
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 668Z8C33LU
• RxNorm Concept Unique ID - RxCUI:
  • 200257
  • 200256
  • 200258

Pharmacological Class

• Glinide [EPC]
• Potassium Channel Antagonists [MoA]

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

NDC	Brand Name	Generic Name
0378-3122	Repaglinide	repaglinide
0378-3123	Repaglinide	repaglinide
0574-0240	Repaglinide	REPAGLINIDE
0574-0241	Repaglinide	REPAGLINIDE
0574-0242	Repaglinide	REPAGLINIDE
51079-539	Repaglinide	repaglinide
51991-853	REPAGLINIDE	REPAGLINIDE
51991-854	REPAGLINIDE	REPAGLINIDE
51991-855	REPAGLINIDE	REPAGLINIDE
57237-157	Repaglinide	Repaglinide
57237-158	Repaglinide	Repaglinide
57237-159	Repaglinide	Repaglinide
57664-745	Repaglinide	Repaglinide
57664-747	Repaglinide	Repaglinide
60429-484	REPAGLINIDE	REPAGLINIDE
60429-485	REPAGLINIDE	REPAGLINIDE
60429-486	REPAGLINIDE	REPAGLINIDE
68084-967	Repaglinide	Repaglinide
68084-954	Repaglinide	Repaglinide
65862-670	Repaglinide	Repaglinide
65862-671	Repaglinide	Repaglinide
65862-672	Repaglinide	Repaglinide
0169-0081	Prandin	repaglinide
0169-0082	Prandin	repaglinide
0169-0084	Prandin	repaglinide