NDC 0078-0351

Starlix

Nateglinide

Starlix is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Nateglinide.

• Product ID: 0078-0351_30f5d4e8-235e-437d-8586-76bae702e8b2
• NDC: 0078-0351
• Product Type: Human Prescription Drug
• Proprietary Name: Starlix
• Generic Name: Nateglinide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2000-12-04
• Marketing Category: NDA / NDA
• Application Number: NDA021204
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: NATEGLINIDE
• Active Ingredient Strength: 60 mg/1
• Pharm Classes: Glinide [EPC],Potassium Channel Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0078-0351-05

100 TABLET in 1 BOTTLE (0078-0351-05)

• Marketing Start Date: 2000-12-04
• Marketing End Date: 2021-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0351-05 [00078035105]

Starlix TABLET

• Marketing Category: NDA
• Application Number: NDA021204
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-12-04
• Marketing End Date: 2021-09-30

Drug Details

Active Ingredients

Ingredient	Strength
NATEGLINIDE	60 mg/1

OpenFDA Data

• SPL SET ID: 5cbda9bc-3c0d-4d75-a37a-994844680c8c
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 41X3PWK4O2
• RxNorm Concept Unique ID - RxCUI:
  • 284529
  • 284530
  • 311919
  • 314142
• UPC Code:
  • 0300780351058

Pharmacological Class

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

NDC Crossover Matching brand name "Starlix" or generic name "Nateglinide"

NDC	Brand Name	Generic Name
0078-0351	Starlix	nateglinide
0078-0352	Starlix	nateglinide
0591-3354	Nateglinide	Nateglinide
0591-3355	Nateglinide	Nateglinide
0615-7585	Nateglinide	Nateglinide
0615-7586	Nateglinide	Nateglinide
16571-758	NATEGLINIDE	NATEGLINIDE
16571-759	NATEGLINIDE	NATEGLINIDE
42291-636	Nateglinide	Nateglinide
42291-637	Nateglinide	Nateglinide
49884-984	Nateglinide	Nateglinide
49884-985	Nateglinide	Nateglinide
51407-656	Nateglinide	nateglinide
51407-657	Nateglinide	nateglinide
52536-063	Nateglinide	Nateglinide
52536-067	Nateglinide	Nateglinide
55111-328	Nateglinide	Nateglinide
55111-329	Nateglinide	Nateglinide
60429-434	Nateglinide	Nateglinide
60429-435	Nateglinide	Nateglinide
60687-673	Nateglinide	nateglinide
60687-684	Nateglinide	nateglinide
64380-167	Nateglinide	nateglinide
64380-168	Nateglinide	nateglinide