Signifor

Product NDC
0078-0635
11-digit product format
000780635
Labeler code
0078
Product ID
0078-0635_d345b840-7810-4bcf-9914-5444d1243a49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pasireotide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA200677
Marketing category
NDA
Marketing start
2012-12-14
Marketing end
2022-09-30
Substance
PASIREOTIDE
Active strength
1 mg/mL
Pharmacologic classes
Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0635-06ML - Milliliter0078-0635ab618fe8-d826-4b8e-99f9-462db736b2fb12013-04-01
0078-0635-20ML - Milliliter0078-0635e73b5058-68d7-43bd-9b3d-606de1ab0d7a12013-04-01
0078-0635-61ML - Milliliter0078-0635d064f3ef-6880-4ba8-9e24-f580d1b0520f12013-04-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0635-200007806352060 PACKAGE in 1 BOX (0078-0635-20) > 6 AMPULE in 1 PACKAGE (0078-0635-06) > 1 mL in 1 AMPULE (0078-0635-61) 60 package2012-12-140000-00-00NoNoCurrent