NDC 0310-6627

SymlinPen

Pramlintide Acetate

SymlinPen is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Pramlintide Acetate.

• Product ID: 0310-6627_15ee192e-97e1-4867-9b0d-b093b841e939
• NDC: 0310-6627
• Product Type: Human Prescription Drug
• Proprietary Name: SymlinPen
• Generic Name: Pramlintide Acetate
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2015-01-08
• Marketing Category: NDA / NDA
• Application Number: NDA021332
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: PRAMLINTIDE ACETATE
• Active Ingredient Strength: 1000 ug/mL
• Pharm Classes: Amylin Agonists [MoA],Amylin Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0310-6627-02

2 CARTRIDGE in 1 CARTON (0310-6627-02) > 2.7 mL in 1 CARTRIDGE

• Marketing Start Date: 2015-01-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-6627-02 [00310662702]

SymlinPen INJECTION

• Marketing Category: NDA
• Application Number: NDA021332
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-01-08

Drug Details

Active Ingredients

Ingredient	Strength
PRAMLINTIDE ACETATE	1000 ug/mL

OpenFDA Data

• SPL SET ID: 4aea30ff-eb0d-45c1-b114-3127966328ff
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 726I6TE06G
• RxNorm Concept Unique ID - RxCUI:
  • 861043
  • 861042
  • 861045
  • 861044

Pharmacological Class

• Amylin Agonists [MoA]
• Amylin Analog [EPC]

NDC Crossover Matching brand name "SymlinPen" or generic name "Pramlintide Acetate"

NDC	Brand Name	Generic Name
0310-6615	SymlinPen	pramlintide acetate
0310-6627	SymlinPen	pramlintide acetate