Colesevelam hydrochloride

Product NDC
51660-995
11-digit product format
516600995
Labeler code
51660
Product ID
51660-995_036fdbc5-98b7-41bb-9f84-871d980167ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Ohm Laboratories, Inc.
Application
NDA022362
Marketing category
NDA
Marketing start
2018-07-17
Marketing end
2023-11-30
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
4 g/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
51660-995-302020-08-14C16284748780-1ab0e2407-3403-f274-e053-dbdaa90a647133e0dfe3-64db-452f-95a7-22dfe663f835
51660-995-302020-07-22C16284748780-1ab0e2407-3403-f274-e053-dbdaa90a647133e0dfe3-64db-452f-95a7-22dfe663f835

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-995-30EA - Each51660-99544d4f7d8-e482-4e03-b088-0f097874ec4312018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-995-305166009953030 PACKET in 1 CARTON (51660-995-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET30 packet2018-07-172023-11-30NoNoCurrent