symlinpen

Generic: pramlintide acetate

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name symlinpen
Generic Name pramlintide acetate
Labeler astrazeneca pharmaceuticals lp
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

pramlintide acetate 1000 ug/mL

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-6627
Product ID 0310-6627_a84753f1-6ac5-4a47-a382-29972938ccaa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021332
Marketing Start 2015-01-08
Marketing End 2027-01-31

Pharmacologic Class

Classes
amylin agonists [moa] amylin analog [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03106627
Hyphenated Format 0310-6627

Supplemental Identifiers

RxCUI
861042 861043 861044 861045
UNII
726I6TE06G

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name symlinpen (source: ndc)
Generic Name pramlintide acetate (source: ndc)
Application Number NDA021332 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1000 ug/mL
source: ndc
Packaging
  • 2 CARTRIDGE in 1 CARTON (0310-6627-02) / 2.7 mL in 1 CARTRIDGE
source: ndc

Packages (1)

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

Ingredients (1)

pramlintide acetate (1000 ug/mL)

Linked Drug Pages (1)

SymlinPen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "a84753f1-6ac5-4a47-a382-29972938ccaa", "openfda": {"unii": ["726I6TE06G"], "rxcui": ["861042", "861043", "861044", "861045"], "spl_set_id": ["4aea30ff-eb0d-45c1-b114-3127966328ff"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CARTRIDGE in 1 CARTON (0310-6627-02)  / 2.7 mL in 1 CARTRIDGE", "package_ndc": "0310-6627-02", "marketing_end_date": "20270131", "marketing_start_date": "20150108"}], "brand_name": "SymlinPen", "product_id": "0310-6627_a84753f1-6ac5-4a47-a382-29972938ccaa", "dosage_form": "INJECTION", "pharm_class": ["Amylin Agonists [MoA]", "Amylin Analog [EPC]"], "product_ndc": "0310-6627", "generic_name": "pramlintide acetate", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SymlinPen", "active_ingredients": [{"name": "PRAMLINTIDE ACETATE", "strength": "1000 ug/mL"}], "application_number": "NDA021332", "marketing_category": "NDA", "marketing_end_date": "20270131", "marketing_start_date": "20150108"}