Diltiazem Hydrochloride

Product NDC
42291-187
11-digit product format
422910187
Labeler code
42291
Product ID
42291-187_e0c99000-341c-7b44-e053-2995a90a2d58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA074984
Marketing category
ANDA
Marketing start
2016-10-05
Marketing end
2023-05-31
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
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
42291-187-50EA - Each42291-187fd11e43a-8f2f-4246-933d-7d03d5a6222912016-11-08
42291-187-90EA - Each42291-187cbd730a4-40af-41c6-bb5e-e577a55d50c912016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-187-5042291018750500 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (42291-187-50) 2016-10-050000-00-00NoNoCurrent
42291-187-904229101879090 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (42291-187-90) 2016-10-050000-00-00NoNoCurrent