Cholestyramine for Oral Suspension

Product NDC
62135-008
Requested package NDC
62135-008-56
11-digit product format
621350008
Labeler code
62135
Product ID
62135-008_f1d8692b-deb3-d55f-e053-2a95a90ae615
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cholestyramine for Oral Suspension
Dosage form
POWDER
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA074561
Marketing category
ANDA
Marketing start
1996-08-15
Substance
CHOLESTYRAMINE
Active strength
4 g/9g
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074561-001LOCHOLESTCHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-15
A074561-002LOCHOLESTCHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074561-001AB
A074561-002AB

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORALAB1996-08-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB1996-08-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORAL1996-08-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORAL1996-08-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORAL1996-08-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORAL1996-08-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORAL1996-08-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORAL1996-08-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORAL1996-08-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORAL1996-08-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORAL1996-08-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORAL1996-08-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074561-001LOCHOLESTEQ 4GM RESIN/PACKETPOWDER / ORAL1996-08-15782e0a99824c…
2021-12-28 21:50 UTC2021-12A074561-002LOCHOLESTEQ 4GM RESIN/SCOOPFULPOWDER / ORAL1996-08-15782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074561-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074561-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074561-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074561-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074561-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074561-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074561-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074561-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074561-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074561-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074561-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074561-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074561-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074561-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074561-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074561-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074561-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074561-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074561-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074561-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074561-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074561-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074561-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074561-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074561-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074561-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074561-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074561-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074561-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074561-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074561-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A074561-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074561-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A074561-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074561-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074561-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074561-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074561-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074561-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074561-002AB1a67488948f0b…

Additional Listing Data#

Finished product
Yes
Brand name base
Cholestyramine for Oral Suspension
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/9g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4B33BGI082Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
848943Internal RxNorm lookup
1801279Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
80db0042-0c05-4509-8a6b-fa9f4783629aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bafdcfac-da3a-43c4-81f4-296b60084636Product name620250623

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-008-56Cholestyramine for Oral Suspension378 g in 1 CANPOWDER3781

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-008-56GM - Gram62135-008278f920d-2d32-4ebb-a0d4-2111c47163c112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-008CHOLESTYRAMINE FOR ORAL SUSPENSION POWDER [CHARTWELL RX, LLC]1Current NDC, Legacy NDC, 1 package rows20230110_80db0042-0c05-4509-8a6b-fa9f4783629a.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
Cholestyramine for Oral SuspensionCHOLESTYRAMINE FOR ORAL SUSPENSIONChartwell RX, LLC80db0042-0c05-4509-8a6b-fa9f4783629a2023-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074561
application number: ANDA074561
ndc (package): 62135-008-56
ndc (product): 62135-008
ndc11 (package): 62135000856

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSN80db0042-0c05-4509-8a6b-fa9f4783629a1
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSN80db0042-0c05-4509-8a6b-fa9f4783629a1
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCD80db0042-0c05-4509-8a6b-fa9f4783629a1
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCD80db0042-0c05-4509-8a6b-fa9f4783629a1
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSY80db0042-0c05-4509-8a6b-fa9f4783629a1
848943cholestyramine resin 4 GM Powder for Oral SuspensionSY80db0042-0c05-4509-8a6b-fa9f4783629a1
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSY80db0042-0c05-4509-8a6b-fa9f4783629a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-008-5662135000856378 g in 1 CAN (62135-008-56) 378 g2023-01-030000-00-00NoNoCurrent