Propafenone Hydrochloride

Product NDC
0378-1259
11-digit product format
003781259
Labeler code
0378
Product ID
0378-1259_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
325 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
0378-1259-05EA - Each0378-12590bf4dfa6-17d7-4de0-b7d9-fe6440cbeacc12016-06-14
0378-1259-91EA - Each0378-12597fc8314d-d7ce-4d4e-b9bd-314e9b32fb7b12016-06-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-1259-910037812599160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1259-91) 2016-05-230000-00-00NoNoCurrent