FDA.reportPublic FDA data

Colesevelam Hydrochloride

Product NDC
68462-620
11-digit product format
684620620
Labeler code
68462
Product ID
68462-620_82044bf3-865e-4816-a6a2-f648d980fff2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colesevelam Hydrochloride
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc.,USA
Application
ANDA202190
Marketing category
ANDA
Marketing start
2018-07-16
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
3.75 g/1
Pharmacologic classes
Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202190-001COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE1.875GM/PACKETFOR SUSPENSION / ORAL2018-07-16
A202190-002COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALAB2018-07-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202190-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202190-001COLESEVELAM HYDROCHLORIDE1.875GM/PACKETFOR SUSPENSION / ORAL2018-07-16a50c72e98297…
2026-08-01 22:54:322026-06A202190-002COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALAB2018-07-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202190-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEGlenmark Pharmaceuticals Inc.,USA2e736dd4-bb64-4f93-9821-7c24ea7d38ec2026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202190
application number: ANDA202190
ndc (product): 68462-620

Additional Listing Data#

Finished product
Yes
Brand name base
Colesevelam Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLESEVELAM HYDROCHLORIDE3.75 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P4SG24WI5QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866905Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e736dd4-bb64-4f93-9821-7c24ea7d38ecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78368210-61ea-2003-e774-9745708f5823Product name920220328
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-620-30Colesevelam Hydrochloride1 in 1 PACKETPOWDER, FOR SUSPENSION110
68462-620-30Colesevelam Hydrochloride30 in 1 BOXPOWDER, FOR SUSPENSION3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-620-30EA - Each68462-620e273047a-7e5b-424f-a1be-7a7c510d113f12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-620COLESEVELAM HYDROCHLORIDE POWDER, FOR SUSPENSION [GLENMARK PHARMACEUTICALS INC.,USA]9Current NDC, Legacy NDC, 2 package rows20230810_2e736dd4-bb64-4f93-9821-7c24ea7d38ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionPSN2e736dd4-bb64-4f93-9821-7c24ea7d38ec10
866905colesevelam hydrochloride 3750 MG Powder for Oral SuspensionSCD2e736dd4-bb64-4f93-9821-7c24ea7d38ec10
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionSY2e736dd4-bb64-4f93-9821-7c24ea7d38ec10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-620-306846206203030 PACKET in 1 BOX (68462-620-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET30 packet2018-07-160000-00-00NoNoCurrent