Diltiazem Hydrochloride

Product NDC
15338-458
11-digit product format
153380458
Labeler code
15338
Product ID
15338-458_6815a490-0925-53e8-e053-2a91aa0ae212
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Apace Packaging, LLC
Application
ANDA074984
Marketing category
ANDA
Marketing start
2016-08-18
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15338-458-092023-11-28C16284748780-19d75b9d0-3d48-f424-e053-dadaa90a57ce665e2beb-aa45-87c7-e053-2a91aa0a234c
15338-458-092020-01-31C16284748780-19d75b9d0-3d48-f424-e053-dadaa90a57ce665e2beb-aa45-87c7-e053-2a91aa0a234c