NDC 0173-0562

AMERGE

Naratriptan Hydrochloride

AMERGE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Naratriptan Hydrochloride.

• Product ID: 0173-0562_5b76fec2-b609-4a83-8276-412205c701f1
• NDC: 0173-0562
• Product Type: Human Prescription Drug
• Proprietary Name: AMERGE
• Generic Name: Naratriptan Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1998-02-26
• Marketing Category: NDA / NDA
• Application Number: NDA020763
• Labeler Name: GlaxoSmithKline LLC
• Substance Name: NARATRIPTAN HYDROCHLORIDE
• Active Ingredient Strength: 3 mg/1
• Pharm Classes: Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0173-0562-00

9 TABLET, FILM COATED in 1 BLISTER PACK (0173-0562-00)

• Marketing Start Date: 1998-02-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0173-0562-00 [00173056200]

AMERGE TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020763
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-02-26

NDC 0173-0562-01 [00173056201]

AMERGE TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020763
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-10-31
• Marketing End Date: 2013-03-04

Drug Details

Active Ingredients

Ingredient	Strength
NARATRIPTAN HYDROCHLORIDE	2.5 mg/1

OpenFDA Data

• SPL SET ID: 13f4a8ec-75a3-4c51-b3bc-6244f3c79e95
• Manufacturer:
  • GlaxoSmithKline LLC
• UNII:
  • 10X8X4P12Z
• RxNorm Concept Unique ID - RxCUI:
  • 314135
  • 311918
  • 213211
  • 213212

Pharmacological Class

• Serotonin 1b Receptor Agonists [MoA]
• Serotonin 1d Receptor Agonists [MoA]
• Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]

NDC Crossover Matching brand name "AMERGE" or generic name "Naratriptan Hydrochloride"

NDC	Brand Name	Generic Name
0173-0561	AMERGE	naratriptan hydrochloride
0173-0562	AMERGE	naratriptan hydrochloride