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Ursodiol 300 mg Capsule, 100-count — NDC 0591-3159-01 (Billing 00591-3159-01)

by Actavis Pharma, Inc. · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Ursodiol 300 mg Capsule from Actavis Pharma, Inc., marketed since Dec 1987 and currently FDA-listed; retail pharmacies pay about $0.4292 per capsule (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 00591-3159-01
🏷️ FDA NDC (as labeled) 0591-3159-01 billing pads the labeler segment with a zero
This package
Contains100-count Cost per ea$0.4292 NADAC Per package$42.92 / 100 capsules Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.6451/unit · Part D plans $0.8106/unit — full pricing hub ↓
Main listing for product 0591-3159 · Also comes in: 11210 capsules 0591-3159-77 12000 capsules 0591-3159-00
On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 0591-3159-01 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
0591 labeler · 3159 product · 01 package
Listing certified through
Dec 31, 2027
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 0591315901 3
Medicaid fills, this package
4,054 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0591-3159-01
Product NDC 0591-3159
11-digit billing NDC 00591315901
NCPDP billing unit EA — each (per item)
SPL Set ID b4303d32-2e1e-4280-baa4-704add1be6f7
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1987-12-31
Dosage form CAPSULE
Substance URSODIOL

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 003095
GCN 01070
HICL code 001370
Ingredient (HICL) Ursodiol
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 D7A
Therapeutic class — specific (HIC3) Bile Salts
AHFS code 56:14.00.00
AHFS class Cholelitholytic Agents
FDB label name URSODIOL 300 MG CAPSULE
FDB brand name Ursodiol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003095
  • GCN: 01070
  • HICL (First Databank): 001370
  • AHFS class code: 56:14.00.00
Why two NDCs? The FDA registers this code as 0591-3159-01 — a 4-4-2 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 labeler segment → 00591-3159-01. 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.

Clinical

Label name URSODIOL 300 MG CAPSULE Ingredient Ursodiol
📖 What it is MedlinePlus · NLM

Ursodiol is used to dissolve gallstones in people who do not want surgery or cannot have surgery to remove gallstones. Ursodiol is also used to prevent the formation of gallstones in overweight people who are losing weight very quickly. Ursodiol is used to treat people with primary biliary cholangitis (PBC; formerly known as a primary biliary cirrhosis; an autoimmune liver disease). Ursodiol is in a class of medications called gallstone dissolution agents. It works by decreasing the production of cholesterol and by dissolving the cholesterol in bile to prevent stone formation and by decreasing...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Ursodiol capsules are used to dissolve certain cholesterol gallstones and to prevent gallstones during rapid weight loss. Urso 250, Urso Forte, and ursod...
  • It’s taken by mouth. For gallstones, capsules are usually divided into 2 or 3 doses a day. For PBC, tablets are taken in two to four divided doses with food. Follow your prescripti...
  • Stomach-related effects are the most common, such as belly pain, diarrhea, constipation, and nausea. Headache and dizziness can also happen. Call your doctor about severe belly pai...
  • Yes. Cholestyramine, colestipol, and aluminum-based antacids may reduce how much ursodiol works. Estrogens, birth control pills, and clofibrate can work against it for gallstones....
📖 Read our full Ursodiol 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 eaPer package
Retail pharmacies payNADAC · weekly $0.429 $42.92 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.6451 $64.51 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $0.8106 $81.06 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.690 $0.416
▼ Down 27% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00591-3159-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE $0.4292 / ea $42.92 1987-12-31 — Active
00591-3159-00 0591-3159-00 12000 CAPSULE in 1 BOX — — — — Active
00591-3159-77 0591-3159-77 11210 CAPSULE in 1 CONTAINER — — — — Active

You're viewing the smallest of 3 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule in 1 bottle.
How does this package differ from NDC 00591-3159-77?
Both are Ursodiol 300 mg Capsule — the drug itself is identical. This page's package is the 100-count one, while NDC 00591-3159-77 is the 11210 capsules package.
What NDC number is used to bill for this package of Ursodiol 300 mg Capsule?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ursodiol 300 mg 50268-0797-15 AvPAK 50 capsules $0.416 — Availability likely save 3%
Ursodiol 300 mg 72664-0217-01 VGYAAN 100 capsules $0.421 AB Availability likely save 2%
Ursodiol 300 mg 00527-1326-01 Lannett 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mgthis 00591-3159-01 Actavis 100 capsules $0.429 — Availability likely —
Ursodiol 300 mg 00904-6221-06 Major 50 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 10702-0237-01 KVK-Tech, 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 24658-0780-01 PuraCap 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 42385-0946-01 Laurus 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 42806-0503-01 Epic 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 59651-0421-01 Aurobindo 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 60687-0100-01 American 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 62135-0430-60 Chartwell 60 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 69238-1540-01 Amneal 100 capsules $0.429 — Availability likely —
Ursodiol 300 mg 70710-1483-01 Zydus 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 72603-0613-01 NorthStar 100 capsules $0.429 AB Availability likely —
Ursodiol 300 mg 24658-0999-10 PuraCap 1000 capsules — AB FDA listed —
Ursodiol 300 mg 42291-0923-01 AvKARE 100 capsules — AB FDA listed —
Ursodiol 300 mg 43063-0871-01 PD-Rx 100 capsules — AB FDA listed —
Ursodiol 300 mg 51407-0754-01 Golden 100 capsules — AB FDA listed —
Ursodiol 300 mg 64380-0844-04 Strides 30 capsules — AB FDA listed —
Ursodiol 300 mg 70771-1524-01 Zydus 100 capsules — AB FDA listed —
Ursodiol 300 mg 72162-2168-01 Bryant 100 capsules — AB FDA listed —
Ursodiol 300 mg 72162-2619-01 Bryant 100 capsules — AB FDA listed —
Ursodiol 300 mg 50268-0864-13 AvPAK 30 capsules — AB FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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

🏛️
1987
On the market since
Dec 1987
📍
2026
Currently FDA-listed
39 years listed
🔓
·
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.

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.

🧪 Avoiding an ingredient? See Ursodiol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

LabelerActavis Pharma, Inc.
Labeler code00591
First marketedDec 1987
Product typeDrug For Further Processing
Portfolio324 products on file

More NDCs from Actavis Pharma, Inc. labeler code 00591

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 FDA label FDA SPL

The complete FDA label for this product, 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. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4.1K
Units reimbursed last 4 qtrs
294K
Gross reimbursed last 4 qtrs
$189.6K
Avg / prescription
$46.78
Avg / unit
$0.6451
Latest quarter Q4 2025
1.1KRx
Medicaid pays / ea
$0.6451
gross reimbursed
vs
NADAC / ea
$0.4292
acquisition cost
=
Spread
+$0.2159
+50% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
57% FFS 43% MCO
Fee-for-service · 2,310 Rx Managed care · 1,744 Rx
State Medicaid map
Alaska: 27,795 units · 3,792 per 100k residents AK Maine: no data reported ME Washington: 4,784 units · 61.2 per 100k residents WA Idaho: 1,587 units · 80.8 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 26,410 units · 447 per 100k residents WI Michigan: 5,291 units · 52.7 per 100k residents MI New York: 62,430 units · 319 per 100k residents NY Vermont: no data reported VT New Hampshire: 263 units · 18.8 per 100k residents NH Oregon: 593 units · 14.0 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 15,566 units · 124 per 100k residents IL Indiana: no data reported IN Ohio: 14,405 units · 122 per 100k residents OH Pennsylvania: 10,571 units · 81.6 per 100k residents PA New Jersey: 8,010 units · 86.2 per 100k residents NJ Massachusetts: 4,079 units · 58.3 per 100k residents MA California: 20,376 units · 52.3 per 100k residents CA Utah: 8,738 units · 256 per 100k residents UT Colorado: 3,539 units · 60.2 per 100k residents CO Nebraska: no data reported NE Missouri: 4,263 units · 68.8 per 100k residents MO Kentucky: 5,409 units · 120 per 100k residents KY West Virginia: no data reported WV Virginia: 4,066 units · 46.6 per 100k residents VA Maryland: 2,862 units · 46.3 per 100k residents MD Connecticut: 1,698 units · 46.9 per 100k residents CT Rhode Island: no data reported RI Arizona: 2,674 units · 36.0 per 100k residents AZ New Mexico: 4,047 units · 191 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 6,292 units · 88.3 per 100k residents TN North Carolina: 12,198 units · 113 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 4,881 units · 107 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 21,357 units · 194 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 731 units · 2.4 per 100k residents TX Florida: 9,077 units · 40.1 per 100k residents FL
Units reimbursed · per 100k residents
2.43,792
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Alaska 3,792 /100k
2 Wisconsin 447 /100k
3 New York 319 /100k
4 Utah 256 /100k
5 Georgia 194 /100k
6 New Mexico 191 /100k
7 Illinois 124 /100k
8 Ohio 122 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 capsules this page00591-3159-01 4,033 Rx · $189,410
12000 capsules00591-3159-00 No Medicaid data
11210 capsules00591-3159-77 No Medicaid data
Drug total (last 4 qtrs): 4,033 Rx · 302,611 units · $189,410 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ursodiol (matched by generic name) — the program that covers self-administered drugs. 18 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ursodiol. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.22M
Claims incl. refills
135.9K
Beneficiaries
83.7K
Spend / beneficiary
$229.71
Spend / claim
$141.44
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC No photo available yet for this listing.
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) ✓ Available
“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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Actavis Pharma, Inc.. 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 11210 capsules (00591-3159-77), 12000 capsules (00591-3159-00). 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?
Actavis Pharma, 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.
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.
← 00591-3153-01 · Actavis 00591-3216-30 · Actavis →
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.