FDA.reportPublic FDA data

COLESEVELAM

Product NDC
70771-1368
11-digit product format
707711368
Labeler code
70771
Product ID
70771-1368_8bd17f3d-9ca2-4ce2-93a1-b4e9d8571079
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
COLESEVELAM
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA207765
Marketing category
ANDA
Marketing start
2019-10-11
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
2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207765-001COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE625MGTABLET / ORALAB2019-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207765-001AB

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 22:54:322026-06A207765-001COLESEVELAM HYDROCHLORIDE625MGTABLET / ORALAB2019-10-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207765-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ColesevelamCOLESEVELAMZydus Pharmaceuticals USA Inc.6a26e745-7e38-4af0-9bcc-566b2812df752025-09-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207765
application number: ANDA207765
COLESEVELAMCOLESEVELAMZydus Lifesciences Limited090eabd5-acd3-43ed-a05b-52f1f3773a932024-11-26Exact identifier
application applno (ANDA): 207765
application number: ANDA207765
ndc (product): 70771-1368

Additional Listing Data#

Finished product
Yes
Brand name base
COLESEVELAM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLESEVELAM HYDROCHLORIDE625 mg/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
866910Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
090eabd5-acd3-43ed-a05b-52f1f3773a93Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
78368210-61ea-2003-e774-9745708f5823Product name920220328
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70771-1368-02024-09-04C16284748780-11030e365-0e11-111a-e063-dadaa90a10e2COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-42024-09-04C16284748780-11030e365-0e11-111a-e063-dadaa90a10e2COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-82024-09-04C16284748780-11030e365-0e11-111a-e063-dadaa90a10e2COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-02024-01-30C16284748780-11030e365-0e11-111a-e063-dadaa90a10e2COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-42024-01-30C16284748780-11030e365-0e11-111a-e063-dadaa90a10e2COLESEVELAM HYDROCHLORIDE TABLETS
70771-1368-82024-01-30C16284748780-11030e365-0e11-111a-e063-dadaa90a10e2COLESEVELAM HYDROCHLORIDE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1368-0COLESEVELAM1000 in 1 BOTTLETABLET10005
70771-1368-2COLESEVELAM10 in 1 BLISTER PACKTABLET105
70771-1368-4COLESEVELAM10 in 1 CARTONTABLET105
70771-1368-8COLESEVELAM180 in 1 BOTTLETABLET1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1368COLESEVELAM TABLET [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 4 package rows20241130_090eabd5-acd3-43ed-a05b-52f1f3773a93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866910colesevelam HCl 625 MG Oral TabletPSN090eabd5-acd3-43ed-a05b-52f1f3773a935
866910colesevelam hydrochloride 625 MG Oral TabletSCD090eabd5-acd3-43ed-a05b-52f1f3773a935

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1368-0707711368001000 TABLET in 1 BOTTLE (70771-1368-0) 1000 tablet2019-10-110000-00-00NoNoCurrent
70771-1368-27077113680210 in 1 BLISTER PACKHistorical
70771-1368-47077113680410 BLISTER PACK in 1 CARTON (70771-1368-4) / 10 TABLET in 1 BLISTER PACK (70771-1368-2) 10 blister pack2019-10-110000-00-00NoNoCurrent
70771-1368-870771136808180 TABLET in 1 BOTTLE (70771-1368-8) 180 tablet2019-10-110000-00-00NoNoCurrent