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⚪no package photo
in the FDA label

Colesevelam hydrochloride 625 mg Tablet, Film Coated, 180-count

by Ohm Laboratories, Inc. · 180 TABLET, FILM COATED in 1 BOTTLE (51660-996-28)
NDC 51660-0996-28
🏷️ FDA NDC (as labeled) 51660-996-28 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Colesevelam Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0340-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Nov 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 51660-996-28
Product NDC 51660-996
11-digit billing NDC 51660099628
NCPDP billing unit EA — each (per item)
Application # NDA021176
Mechanism of action Bile Acid Sequestrant [EPC], Bile-acid Binding Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Nov 2023)
Route ORAL
Dosage form TABLET, FILM COATED
Substance COLESEVELAM HYDROCHLORIDE
GCN Seq No 046172
GCN 16300
HICL code 021452
Ingredient (HICL) Colesevelam Hcl
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D7
Therapeutic class — intermediate (HIC2) Act Primarily On Liver/Biliary Tract
HIC3 code D7L
Therapeutic class — specific (HIC3) Bile Salt Sequestrants
AHFS code 24:06.04.00
AHFS class Bile Acid Sequestrants
FDB label name COLESEVELAM 625 MG TABLET
FDB brand name Colesevelam Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 51660-996-28 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 51660-0996-28. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerOhm Laboratories, Inc.
Application holderCOSETTE PHARMACEUTICALS INC
FDA applicationNDA021176 (NDA)
Labeler code51660
Product typeHuman Prescription Drug
Portfolio4 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name COLESEVELAM 625 MG TABLET Ingredient Colesevelam Hcl
📖 What it is MedlinePlus · NLM

Colesevelam is used to decrease the amount of cholesterol (a fat-like substance that can build up in blood vessels leading to heart attack or strokes or other medical conditions) control blood sugar levels in adults with type 2 diabetes (condition in which the body does not use insulin normally leading to high blood sugar) Colesevelam is in a class of medications called bile acid sequestrants. It works by binding bile acids in your intestines to form a product that is removed from the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • That depends on why your doctor prescribed it. If you have high LDL cholesterol, colesevelam helps pull that 'bad' cholesterol down by working inside your gut — it's never absorbed...
  • What exactly is colesevelam supposed to do for me?
  • Yes, timing really matters here. Colesevelam — whether you're taking the tablets or mixing the powder into a drink — should always be taken with a meal. The tricky part is that it...
  • How do I take it, and does it matter when I take my other medications?
📖 Read our full Colesevelam guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.252 $45.41 / 180 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $0.488 $0.243
▼ Down 36% over the last 15 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Colesevelam hydrochloride 625 mgthis 51660-0996-28 Ohm 180 tablets $0.252 AB Discontinued —
Colesevelam Hydrochloride 625 mg 00115-1320-19 Amneal 180 tablets $0.261 AB Availability likely +3%
Colesevelam Hydrochloride 625 mg 00713-0936-81 Cosette 180 tablets $0.261 AB Discontinued +3%
Colesevelam hydrochloride 625 mg 27808-0190-01 Cranbury 180 tablets $0.261 AB Availability likely +3%
Colesevelam Hydrochloride 625 mg 43598-0230-18 Dr.Reddys 180 tablets $0.261 AB Availability likely +3%
Colesevelam Hydrochloride 625 mg 60687-0385-25 American 1 tablet $0.261 AB Availability likely +3%
colesevelam hydrochloride 625 mg 68462-0433-18 Glenmark 180 tablets $0.261 AB Availability likely +3%
Colesevelam Hydrochloride 625 mg 69452-0158-25 Bionpharma 180 tablets $0.261 AB Availability likely +3%
Colesevelam Hydrochloride 625 mg 69452-0493-25 Bionpharma 180 tablets $0.261 AB Availability likely +3%
Welchol 625 mg 00713-0879-81 Cosette 180 tablets $5.672 AB Discontinued +2148%
Colesevelam Hydrochloride 625 mg 33342-0197-57 Macleods 180 tablets — — FDA listed —
Colesevelam HCL 625 mg 50090-4371-00 A-S 90 tablets — AB FDA listed —
Colesevelam Hydrochloride 625 mg 50090-6994-00 A-S 90 tablets — AB FDA listed —
Colesevelam Hydrochloride 625 mg 50090-6995-00 A-S 90 tablets — AB FDA listed —
colesevelam hydrochloride 625 mg 50090-7459-00 A-S 90 tablets — AB FDA listed —
colesevelam hydrochloride 625 mg 50090-7460-00 A-S 90 tablets — AB FDA listed —
Colesevelam hydrochloride 625 mg 50090-7604-00 A-S 90 tablets — AB FDA listed —
Colesevelam hydrochloride 625 mg 50090-7605-00 A-S 90 tablets — AB FDA listed —
Colesevelam HCL 625 mg 50090-7811-00 A-S 90 tablets — AB FDA listed —
Colesevelam Hydrochloride 625 mg 51407-0336-18 Golden 180 tablets — AB FDA listed —
Colesevelam HCL 625 mg 63629-8767-01 Bryant 180 tablets — AB FDA listed —
Colesevelam HCL 625 mg 67877-0506-05 Ascend 500 tablets — AB FDA listed —
Colesevelam 625 mg 68382-0619-10 Zydus 1000 tablets — AB FDA listed —
Colesevelam 625 mg 70771-1368-00 Zydus 1000 tablets — AB FDA listed —
Colesevelam HCL 625 mg 71335-2905-01 Bryant 180 tablets — AB FDA listed —
Colesevelam HCL 625 mg 72162-1846-02 Bryant 180 tablets — AB FDA listed —
Colesevelam HCL 625 mg 72789-0476-93 PD-Rx 180 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51660-0996-28 You're viewing this 180 TABLET, FILM COATED in 1 BOTTLE (51660-996-28) 2018-05-23 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC The FDA label for this product carries no photos.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51660-996-28, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51660-0996-28, written without dashes as 51660099628. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51660-0996-28, the first segment (51660) is the labeler code FDA assigned to Ohm Laboratories, Inc.; the middle segment (0996) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (28) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Ohm Laboratories, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
← 51660-0940-12 · Ohm 51660-0998-30 · OHM →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.