Colestid

Product NDC
0009-0450
11-digit product format
000090450
Labeler code
0009
Product ID
0009-0450_62a88ff5-632d-4fe7-a4e5-1170f1c70dd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Colestipol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA020222
Marketing category
NDA
Marketing start
1994-07-19
Substance
COLESTIPOL HYDROCHLORIDE
Active strength
1 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
N020222-001COLESTIDCOLESTIPOL HYDROCHLORIDE1GMTABLET / ORALABRLD1994-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020222-001AB

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-193f01610625f2…
2019-09-15 20:21 UTC2019-09N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N020222-001COLESTID1GMTABLET / ORALABRLD, RS1994-07-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020222-001COLESTID1GMTABLET / ORALABRLD1994-07-19e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020222-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020222-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020222-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020222-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020222-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020222-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020222-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020222-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020222-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020222-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020222-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020222-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020222-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020222-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020222-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020222-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020222-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020222-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020222-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020222-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020222-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020222-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020222-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020222-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020222-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020222-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020222-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020222-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020222-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020222-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020222-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020222-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020222-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020222-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020222-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020222-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020222-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020222-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020222-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020222-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLESTIPOL HYDROCHLORIDE1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X7D10K905GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1048445Internal RxNorm lookup
1048447Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e270911-f27b-44d4-b0a2-33506418cc1dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7ee3fbbc-8b06-ecd3-0995-c8769bc203d2Product name420250317
a2f9a12b-9d1e-48b5-8706-66d8e6a71a3bProduct name120180626

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-0450-03Colestid120 in 1 BOTTLETABLET12015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0450-03EA - Each0009-04508cf3f290-9a33-47bb-8e4d-22bee9d0203d12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0450COLESTID (COLESTIPOL HYDROCHLORIDE) TABLET [PHARMACIA & UPJOHN COMPANY LLC]15Current NDC, Legacy NDC, 1 package rows20241027_3e270911-f27b-44d4-b0a2-33506418cc1d.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colestipol HydrochlorideCOLESTIPOL HYDROCHLORIDEMylan Pharmaceuticals Inc.dae7d51e-c117-4c8a-b018-45b01ae461002025-05-13Adverse reactionsExact identifier
application applno (NDA): 020222
application number: NDA020222
ColestidCOLESTIPOL HYDROCHLORIDEPharmacia & Upjohn Company LLC3e270911-f27b-44d4-b0a2-33506418cc1d2024-10-24Adverse reactionsExact identifier
application applno (NDA): 020222
application number: NDA020222
ndc (product): 0009-0450

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1048447Colestid 1 GM Oral TabletPSN3e270911-f27b-44d4-b0a2-33506418cc1d15
1048445colestipol HCl 1 GM Oral TabletPSN3e270911-f27b-44d4-b0a2-33506418cc1d15
1048447colestipol hydrochloride 1000 MG Oral Tablet [Colestid]SBD3e270911-f27b-44d4-b0a2-33506418cc1d15
1048445colestipol hydrochloride 1000 MG Oral TabletSCD3e270911-f27b-44d4-b0a2-33506418cc1d15
1048447Colestid 1 GM Oral TabletSY3e270911-f27b-44d4-b0a2-33506418cc1d15
1048447Colestid 1000 MG Oral TabletSY3e270911-f27b-44d4-b0a2-33506418cc1d15
1048445colestipol hydrochloride 1 GM Oral TabletSY3e270911-f27b-44d4-b0a2-33506418cc1d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0450-0300009045003120 TABLET in 1 BOTTLE (0009-0450-03) 120 tablet1994-07-190000-00-00NoNoCurrent