NDC 68258-8961

SEREVENT DISKUS

Salmeterol Xinafoate

SEREVENT DISKUS is a Oral; Respiratory (inhalation) Powder, Metered in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Salmeterol Xinafoate.

• Product ID: 68258-8961_198f20a2-218e-4a0f-a4c1-ae7c3b62e1c6
• NDC: 68258-8961
• Product Type: Human Prescription Drug
• Proprietary Name: SEREVENT DISKUS
• Generic Name: Salmeterol Xinafoate
• Dosage Form: Powder, Metered
• Route of Administration: ORAL; RESPIRATORY (INHALATION)
• Marketing Start Date: 1997-11-25
• Marketing Category: NDA / NDA
• Application Number: NDA020692
• Labeler Name: Dispensing Solutions, Inc.
• Substance Name: SALMETEROL XINAFOATE
• Active Ingredient Strength: 50 ug/1
• Pharm Classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68258-8961-6

60 POWDER, METERED in 1 INHALER (68258-8961-6)

• Marketing Start Date: 1997-11-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68258-8961-6 [68258896106]

SEREVENT DISKUS POWDER, METERED

• Marketing Category: NDA
• Application Number: NDA020692
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1997-11-25
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
SALMETEROL XINAFOATE	50 ug/1

OpenFDA Data

• SPL SET ID: c4925b2c-bde1-45fd-8109-dc75bee3b7a3
• Manufacturer:
  • Dispensing Solutions, Inc.
• UNII:
  • 6EW8Q962A5
• RxNorm Concept Unique ID - RxCUI:
  • 866048
  • 866049

Pharmacological Class

• Adrenergic beta2-Agonists [MoA]
• beta2-Adrenergic Agonist [EPC]

NDC Crossover Matching brand name "SEREVENT DISKUS" or generic name "Salmeterol Xinafoate"

NDC	Brand Name	Generic Name
0173-0520	SEREVENT	salmeterol xinafoate
0173-0521	SEREVENT	salmeterol xinafoate
68258-8961	SEREVENT	salmeterol xinafoate