NDC 0173-0863

AVANDIA 4MG

Rosiglitazone Maleate

AVANDIA 4MG is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Rosiglitazone Maleate.

• Product ID: 0173-0863_227f6090-7f83-43bf-9abd-842b8c5b0808
• NDC: 0173-0863
• Product Type: Human Prescription Drug
• Proprietary Name: AVANDIA 4MG
• Generic Name: Rosiglitazone Maleate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-05-25
• Marketing Category: NDA / NDA
• Application Number: NDA021071
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: ROSIGLITAZONE MALEATE
• Active Ingredient Strength: 4 mg/1
• Pharm Classes: Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0173-0863-13

30 TABLET, FILM COATED in 1 BOTTLE (0173-0863-13)

• Marketing Start Date: 2011-05-25
• Marketing End Date: 2021-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0863-13 [00173086313]

AVANDIA 4MG TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021071
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-05-25

Drug Details

Active Ingredients

Ingredient	Strength
ROSIGLITAZONE MALEATE	4 mg/1

OpenFDA Data

• SPL SET ID: ec682aec-e98f-41a1-9d21-eb7580ea3a8a
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • KX2339DP44
• RxNorm Concept Unique ID - RxCUI:
  • 261242
  • 261241
  • 312859
  • 312860
• UPC Code:
  • 0301730861184
  • 0301730863133

Pharmacological Class

• Peroxisome Proliferator Receptor gamma Agonist [EPC]
• Peroxisome Proliferator-activated Receptor Activity [MoA]
• PPAR gamma [CS]
• Thiazolidinedione [EPC]
• Thiazolidinediones [CS]

NDC Crossover Matching brand name "AVANDIA 4MG" or generic name "Rosiglitazone Maleate"

NDC	Brand Name	Generic Name
0173-0861	AVANDIA	rosiglitazone maleate
0173-0863	AVANDIA	rosiglitazone maleate