Colesevelam hydrochloride

Product NDC
51660-996
11-digit product format
516600996
Labeler code
51660
Product ID
51660-996_036fdbc5-98b7-41bb-9f84-871d980167ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ohm Laboratories, Inc.
Application
NDA021176
Marketing category
NDA
Marketing start
2018-05-23
Marketing end
2023-11-30
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
625 mg/1
Pharmacologic classes
Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51660-996-282020-08-14C16284748780-1ab0e2407-3403-f274-e053-dbdaa90a647133e0dfe3-64db-452f-95a7-22dfe663f835
51660-996-282020-07-22C16284748780-1ab0e2407-3403-f274-e053-dbdaa90a647133e0dfe3-64db-452f-95a7-22dfe663f835

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-996-28EA - Each51660-9961ef2a656-3fa7-45d6-a0f5-de9c059801de12018-06-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51660-996-2851660099628180 TABLET, FILM COATED in 1 BOTTLE (51660-996-28) 2018-05-232023-11-30NoNoCurrent