FDA.reportPublic FDA data

Colesevelam hydrochloride

Product NDC
0115-1864
11-digit product format
001151864
Labeler code
0115
Product ID
0115-1864_83f79a9e-7658-4d89-a3aa-8c5ee39ac846
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colesevelam hydrochloride
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA212886
Marketing category
ANDA
Marketing start
2023-01-20
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212886-001COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-18

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
2026-08-18 06:07:402026-07A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALAB2023-01-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALAB2023-01-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALAB2023-01-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALAB2023-01-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALAB2023-01-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALAB2023-01-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALAB2023-01-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALAB2023-01-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORALAB2023-01-18053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212886-001COLESEVELAM HYDROCHLORIDE3.75GM/PACKETFOR SUSPENSION / ORAL2023-01-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A212886-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212886-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212886-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212886-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212886-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212886-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212886-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212886-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212886-001AB1053a50430f4f…

Additional Listing Data#

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

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
f33fbf30-2486-49a7-bbe8-0ddfb4b9b786Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78368210-61ea-2003-e774-9745708f5823Product name920220328

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1864-18Colesevelam hydrochloride30 in 1 CARTONFOR SUSPENSION304
0115-1864-30Colesevelam hydrochloride1 in 1 PACKETFOR SUSPENSION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1864-18EA - Each0115-1864215928fb-d4ad-4fad-8d19-77217e14699a12023-04-07
0115-1864-30EA - Each0115-18648062eef0-c9c2-415d-82c3-ab03d474d98c12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1864COLESEVELAM HYDROCHLORIDE FOR SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]4Current NDC, 2 package rows20230120_f33fbf30-2486-49a7-bbe8-0ddfb4b9b786.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCf33fbf30-2486-49a7-bbe8-0ddfb4b9b7862022-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212886
application number: ANDA212886
ndc (product): 0115-1864

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionPSNf33fbf30-2486-49a7-bbe8-0ddfb4b9b7864
866905colesevelam hydrochloride 3750 MG Powder for Oral SuspensionSCDf33fbf30-2486-49a7-bbe8-0ddfb4b9b7864
866905colesevelam HCl 3.75 GM Powder for Oral SuspensionSYf33fbf30-2486-49a7-bbe8-0ddfb4b9b7864

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0115-1864-180011518641830 PACKET in 1 CARTON (0115-1864-18) / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30) 30 packet2023-01-20NoNoCurrent
0115-1864-30001151864301 in 1 PACKETHistorical