Labetalol Hydrochloride

Product NDC
24979-170
11-digit product format
249790170
Labeler code
24979
Product ID
24979-170_03d305c1-fb1e-4c39-b743-157ae33343dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TWi Pharmaceuticals, Inc.
Application
ANDA209603
Marketing category
ANDA
Marketing start
2018-08-01
Marketing end
0000-00-00
Substance
LABETALOL HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [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
24979-170-01EA - Each24979-17032fb4103-03f6-43b9-a0fa-6c913d2b66df12018-10-11
24979-170-02EA - Each24979-17007849496-e0e5-4c54-9444-cbdc6407c81212018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24979-170-0124979017001100 TABLET, FILM COATED in 1 BOTTLE (24979-170-01) 2018-08-010000-00-00NoNoCurrent
24979-170-0224979017002500 TABLET, FILM COATED in 1 BOTTLE (24979-170-02) 2018-08-010000-00-00NoNoCurrent
24979-170-062497901700630 TABLET, FILM COATED in 1 BOTTLE (24979-170-06) 2018-08-010000-00-00NoNoCurrent