Propafenone Hydrochloride

Product NDC
0378-1258
11-digit product format
003781258
Labeler code
0378
Product ID
0378-1258_173fd954-8e93-4c80-b41d-60f12b19f275
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propafenone
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA203803
Marketing category
ANDA
Marketing start
2016-05-23
Marketing end
0000-00-00
Substance
PROPAFENONE HYDROCHLORIDE
Active strength
225 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1258-05EA - Each0378-12583d5f79c6-a328-4efc-84a6-bc379981995e12016-06-14
0378-1258-91EA - Each0378-1258c6220480-2785-4d08-a362-ae5867c5817912016-06-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-1258-910037812589160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1258-91) 2016-05-230000-00-00NoNoCurrent