Propafenone Hydrochloride

Product NDC
0378-1261
11-digit product format
003781261
Labeler code
0378
Product ID
0378-1261_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
425 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
0378-1261-05EA - Each0378-126135ac551a-f41a-42fa-bcd2-7e0e018d8e4212016-06-14
0378-1261-91EA - Each0378-1261ddaabd08-109a-4f15-8b1a-61f4fdaa9a9b12016-06-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-1261-910037812619160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1261-91) 2016-05-230000-00-00NoNoCurrent