Home NDC 0115-5212 COLESTIPOL HYDROCHLORIDE
Product NDC 0115-5212
11-digit product format 001155212
Labeler code 0115
Product ID 0115-5212_78f0e0f5-e61e-4c11-8e35-b65bcdfcfc06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COLESTIPOL HYDROCHLORIDE
Dosage form SUSPENSION
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA077277
Marketing category ANDA
Marketing start 2006-05-02
Substance COLESTIPOL HYDROCHLORIDE
Active strength 5 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077277-001 COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL 2006-05-02 A077277-002 COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL 2006-05-02
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 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL 2006-05-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL 2006-05-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077277-001 COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE / ORAL AB 2006-05-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077277-002 COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE / ORAL AB 2006-05-02 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Additional Listing Data#
Finished product Yes
Brand name base COLESTIPOL HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COLESTIPOL HYDROCHLORIDE 5 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X7D10K905G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1048450 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0115-5212-18 COLESTIPOL HYDROCHLORIDE 30 in 1 CARTON SUSPENSION 30 12 0115-5212-29 COLESTIPOL HYDROCHLORIDE 90 in 1 CARTON SUSPENSION 90 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-5212 COLESTIPOL HYDROCHLORIDE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 12 Current NDC, Legacy NDC, 2 package rows 20231231_839354bd-cbac-4d18-8c02-b1b93766af38.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0115-5212-18 00115521218 30 SUSPENSION in 1 CARTON (0115-5212-18) 30 suspension 2006-05-02 0000-00-00 No No Current 0115-5212-29 00115521229 90 SUSPENSION in 1 CARTON (0115-5212-29) 90 suspension 2006-05-02 0000-00-00 No No Current