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Colesevelam 625 mg Tablet, 1,000-count — NDC 70771-1368-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Colesevelam 625 mg Tablet, 1,000-count — NDC 70771-1368-0 (Billing 70771-1368-00)

by Zydus Lifesciences Limited · 1000 TABLET in 1 BOTTLE

This is a package of 1,000 tablets of Colesevelam 625 mg Tablet from Zydus Lifesciences Limited, marketed since Oct 2019 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 70771-1368-00
🏷️ FDA NDC (as labeled) 70771-1368-0 billing pads the package segment with a zero
This package
Contains1,000-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.6676/unit — full pricing hub ↓
Main listing for product 70771-1368 · Also comes in: 100 tablets 70771-1368-4 180 tablets 70771-1368-8
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · 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

NDC database record

One package, one record: these facts belong to NDC 70771-1368-0 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70771 labeler · 1368 product · 0 package
Package marketed since
Oct 11, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7077113680 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1368-0
Product NDC 70771-1368
11-digit billing NDC 70771136800
RxCUI 866910
UNII P4SG24WI5Q
Application # ANDA207765
SPL Set ID 090eabd5-acd3-43ed-a05b-52f1f3773a93
Established class (EPC) Bile Acid Sequestrant
Mechanism of action Bile-acid Binding Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-11
Route ORAL
Dosage form TABLET
Substance COLESEVELAM HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 866910
Why two NDCs? The FDA registers this code as 70771-1368-0 — a 5-4-1 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 package segment → 70771-1368-00. 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.

RxNorm drug class

This medicine belongs to the Bile Acid Sequestrant class.

Pharmacologic class Bile Acid Sequestrant
Drug family (ATC) Bile acid sequestrants
How it works Bile-acid Binding Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 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
  • It lowers LDL cholesterol in adults with high cholesterol and in teens ages 10 to 17 with an inherited form called HeFH. Some products, including Welchol, are also used to improve...
  • Take it with a meal. Tablets go down with a liquid, and the powder is stirred into water, juice, or diet soda. Follow your prescriber’s directions and your label for how much.
  • Constipation, indigestion, and nausea are the most common. Call your doctor or get help for severe belly pain, severe constipation, or trouble swallowing.
  • Some medicines need spacing. Take things like thyroid medicine, phenytoin, birth control pills, olmesartan, sulfonylureas, cyclosporine, and vitamins at least 4 hours before colese...
📖 Read our full Colesevelam guide →
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.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 · Q2 2026 $0.6676 $667.60 / 1000 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70771-1368-00 You're viewing this Main listing 1000 TABLET in 1 BOTTLE 2019-10-11 — Active
70771-1368-04 70771-1368-4 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK 2019-10-11 — Active
70771-1368-08 70771-1368-8 180 TABLET in 1 BOTTLE 2019-10-11 — Active

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 tablet in 1 bottle.
How does this package differ from NDC 70771-1368-04?
Both are Colesevelam 625 mg Tablet — the drug itself is identical. This page's package is the 1,000-count one, while NDC 70771-1368-04 is the 100 tablets package.
What NDC number is used to bill for this package of Colesevelam 625 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Colesevelam Hydrochloride 625 mg 00115-1320-19 Amneal 180 tablets $0.262 AB Availability likely —
Colesevelam Hydrochloride 625 mg 00713-0936-81 Cosette 180 tablets $0.262 AB Discontinued —
Colesevelam hydrochloride 625 mg 27808-0190-01 Cranbury 180 tablets $0.262 AB Availability likely —
Colesevelam Hydrochloride 625 mg 43598-0230-18 Dr.Reddys 180 tablets $0.262 AB Availability likely —
Colesevelam Hydrochloride 625 mg 60687-0385-25 American 1 tablet $0.262 AB Availability likely —
colesevelam hydrochloride 625 mg 68462-0433-18 Glenmark 180 tablets $0.262 AB Availability likely —
Colesevelam Hydrochloride 625 mg 69452-0158-25 Bionpharma 180 tablets $0.262 AB Availability likely —
Colesevelam Hydrochloride 625 mg 69452-0493-25 Bionpharma 180 tablets $0.262 AB Availability likely —
Welchol 625 mg 00713-0879-81 Cosette 180 tablets $5.672 AB Discontinued —
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 mgthis 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 a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

What it looks like

Color Yellow
ShapeCapsule
Imprint619
Size2 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA207765 (ANDA)
Labeler code70771
First marketedOct 2019
Product typeHuman Prescription Drug
Portfolio720 products on file

More NDCs from Zydus Lifesciences Limited labeler code 70771

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.

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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 16 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Colesevelam Hydrochloride Tablets, 625 mg NDC 70771-1368-8 180 Tablets Rx only image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
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) ✓ Available
Package photos ✓ Available
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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 price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Lifesciences Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 100 tablets (70771-1368-04), 180 tablets (70771-1368-08). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Zydus Lifesciences Limited 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.
← 70771-1367-00 · Zydus 70771-1369-00 · Zydus →
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.