Home › NDC Lookup › Ingredients › Dicyclomine Hydrochloride › 59651-0719-01
Dicyclomine Hydrochloride 10 mg Capsule, 100-count — NDC 59651-0719-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dicyclomine Hydrochloride 10 mg Capsule, 100-count — NDC 59651-719-01 (Billing 59651-0719-01)

by Aurobindo Pharma Limited · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Dicyclomine Hydrochloride 10 mg Capsule from Aurobindo Pharma Limited, marketed since May 2023 and currently FDA-listed; retail pharmacies pay about $0.0778 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 59651-0719-01
🏷️ FDA NDC (as labeled) 59651-719-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0778 NADAC Per package$7.78 / 100 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1716/unit · Part D plans $0.1589/unit — full pricing hub ↓
Main listing for product 59651-719 · Also comes in: 1000 capsules 59651-719-99
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

🚨
Active recall for this product.
Class II · Jul 23, 2026 — shortfill; reports of empty capsules. (Aurobindo Pharma USA Inc) · FDA recall D-0733-2026
Lots / codes: Batch # DMC125018A, Exp Date: 07/2027. · reported Aug 12, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59651-719-01
Product NDC 59651-719
11-digit billing NDC 59651071901
NCPDP billing unit EA — each (per item)
RxCUI 991061
UNII CQ903KQA31
UPC 0359651719015
Application # ANDA040319
SPL Set ID ec746016-eed0-4e37-bb9c-cb430c8a7f07
Established class (EPC) Anticholinergic
Mechanism of action Cholinergic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-08
Route ORAL
Dosage form CAPSULE
Substance DICYCLOMINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 49103010100105
GCN Seq No 004918
GCN 19261
HICL code 002045
Ingredient (HICL) Dicyclomine Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J2
Therapeutic class — intermediate (HIC2) Anticholinergics
HIC3 code J2D
Therapeutic class — specific (HIC3) Anticholinergics/Antispasmodics
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name DICYCLOMINE 10 MG CAPSULE
FDB brand name Dicyclomine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004918
  • GCN: 19261
  • GPI-14 (Medi-Span): 49103010100105
  • HICL (First Databank): 002045
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 991061
Why two NDCs? The FDA registers this code as 59651-719-01 — 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 → 59651-0719-01. 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.

RxNorm drug class

This medicine belongs to the Anticholinergic class.

Pharmacologic class Anticholinergic
Drug family (ATC) Synthetic anticholinergics, esters with tertiary amino group
How it works Cholinergic Antagonists
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

Label name DICYCLOMINE 10 MG CAPSULE Ingredient Dicyclomine Hcl
📖 What it is MedlinePlus · NLM

Dicyclomine is used to treat the symptoms of irritable bowel syndrome. Dicyclomine is in a class of medications called anticholinergics. It relieves muscle spasms in the gastrointestinal tract by blocking the activity of a certain natural substance in the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats functional bowel/irritable bowel syndrome. It helps calm the spasms and cramping in your intestines.
  • The capsules, tablets and solution are taken by mouth, generally four times a day. Your prescriber may adjust the amount after a week or so. If you miss a dose, just carry on with...
  • Dry mouth, dizziness and blurred vision are the most common. Nausea, drowsiness, weakness and nervousness can happen too. Be careful driving until you know how it affects you.
  • Call if you feel confused, see or hear things that aren't there, have a racing heartbeat, or can't pass urine. Also call if you overheat without sweating or have diarrhea with a co...
📖 Read our full Dicyclomine 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.

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 $0.078 $7.78 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.1716 $17.16 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $0.1589 $15.89 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.123 $0.075
▼ Down 37% over the last 13 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
59651-0719-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE $0.0778 / ea $7.78 2023-05-08 — Active
59651-0719-99 59651-719-99 1000 CAPSULE in 1 BOTTLE $0.0778 / ea $77.75 2023-05-08 — Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0778 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 79% 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 59651-0719-99?
Both are Dicyclomine Hydrochloride 10 mg Capsule — the drug itself is identical. This page's package is the 100-count one, while NDC 59651-0719-99 is the 1000 capsules package.
What NDC number is used to bill for this package of Dicyclomine Hydrochloride 10 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
Dicyclomine hydrochloride 10 mg 00054-0748-25 Hikma 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 00527-0586-01 Lannett 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 00591-0794-01 Actavis 100 capsules $0.078 AB Availability likely —
Dicyclomine hydrochloride 10 mg 00832-6053-10 Upsher-Smith 1000 capsules $0.078 AB Discontinued —
Dicyclomine Hydrochloride 10 mg 00904-6987-61 Major 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 16571-0260-01 Rising 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 24979-0201-01 Upsher-Smith 100 capsules $0.078 AB Availability likely —
Dicyclomine hydrochloride 10 mg 31722-0052-01 Camber 100 capsules $0.078 AB Availability likely —
Dicyclomine hydrochloride 10 mg 43547-0634-10 Solco 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 50268-0199-15 AvPAK 50 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mgthis 59651-0719-01 Aurobindo 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 60687-0369-01 American 100 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 62135-0718-90 Chartwell 90 capsules $0.078 AB Availability likely —
Dicyclomine Hydrochloride 10 mg 73473-0800-01 Solaris 100 capsules $0.078 AB Availability likely —
Dicyclomine hydrochloride 10 mg 00615-8483-39 NCS 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 42708-0160-56 QPharma, 56 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 43063-0112-04 PD-Rx 4 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 43063-0629-28 PD-Rx 28 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 50090-0126-00 A-S 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 50090-0127-00 A-S 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 50090-7340-00 A-S 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 50090-7341-01 A-S 28 capsules — AB FDA listed —
Dicyclomine hydrochloride 10 mg 50090-7729-00 A-S 30 capsules — AB FDA listed —
Dicyclomine hydrochloride 10 mg 51407-0783-01 Golden 100 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 51655-0219-27 Northwind 12 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 55154-3565-00 Cardinal 10 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 55154-8183-00 Cardinal 10 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 55289-0923-20 PD-Rx 20 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 55700-0766-30 Quality 30 capsules — AB Discontinued —
Dicyclomine Hydrochloride 10 mg 63187-0196-30 Proficient 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 66267-0291-30 NuCare 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 67046-1258-03 Coupler 30 capsules — AB FDA listed —
Dicyclomine hydrochloride 10 mg 67046-1513-03 Coupler 30 capsules — AB FDA listed —
Dicyclomine hydrochloride 10 mg 67296-2158-03 Redpharm 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 68071-3035-03 NuCare 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 68071-3310-01 NuCare 16 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 68071-3674-03 NuCare 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 68788-8578-01 Preferred 100 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 70518-4331-00 REMEDYREPACK 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 70518-4432-00 REMEDYREPACK 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 71205-0428-15 Proficient 15 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 71335-0471-01 Bryant 30 capsules — AB Discontinued —
Dicyclomine Hydrochloride 10 mg 71335-0938-01 Bryant 30 capsules — AB Discontinued —
Dicyclomine Hydrochloride 10 mg 71335-2316-01 Bryant 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 71335-9709-01 Bryant 30 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 71610-0265-09 Aphena 9000 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 72162-2613-00 Bryant 1000 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 72789-0522-01 PD-Rx 100 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 72789-0546-28 PD-Rx 28 capsules — AB FDA listed —
Dicyclomine hydrochloride 10 mg 72888-0105-00 Advagen 1000 capsules — AB FDA listed —
Dicyclomine Hydrochloride 10 mg 67296-2310-03 Redpharm 30 capsules — AB FDA listed —
dicyclomine hydrochloride 10 mg 00054-0883-25 Hikma 100 capsules — 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

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 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 Turquoise
ShapeCapsule
ImprintDIL;10
Size14 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA USA INC
FDA applicationANDA040319 (ANDA)
Labeler code59651
First marketedMay 2023
Product typeHuman Prescription Drug
Portfolio1,456 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

1 INDICATIONS AND USAGE Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome ( 1 )

⏱️ Dosage and Administration 187 words ▾

2 DOSAGE AND ADMINISTRATION Dosage must be adjusted to individual patient needs. Dosage for dicyclomine must be adjusted to individual patient needs ( 2 ). If a dose is missed, patients should continue the normal dosing schedule ( 2 ).

Oral in adults ( 2.1 ): Starting dose: 20 mg 4 times a day. After a week treatment with the starting dose, the dose may be escalated to 40 mg 4 times a day, unless side effects limit dosage escalation Discontinue dicyclomine if efficacy not achieved or side effects require doses less than 80 mg per day after 2 weeks of treatment

2.1Oral Dosage and Administration in Adults The recommended initial dose is 20 mg 4 times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg 4 times a day unless side effects limit dosage escalation. If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued.

Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

💊 Dosage Forms and Strengths 66 words ▾

3 DOSAGE FORMS AND STRENGTHS Dicyclomine Hydrochloride Capsules, USP are available containing 10 mg of dicyclomine hydrochloride, USP. A No. 4, light turquoise blue opaque cap and light turquoise blue opaque body, hard-shell gelatin capsule filled with a white to off-white powder. The capsule is axially printed with ‘DIL’ on cap and ‘10’ on body in black ink. Dicyclomine hydrochloride capsules 10 mg ( 3 )

⛔ Contraindications 147 words ▾

4 CONTRAINDICATIONS Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific Populations (8.4) ], nursing mothers [see Use in Specific Populations (8.3) ] and in patients with: unstable cardiovascular status in acute hemorrhage myasthenia gravis [see Warnings and Precautions (5.4) ] glaucoma [see Adverse Reactions (6.3) and Drug Interactions (7.1) ] obstructive uropathy [see Warnings and Precautions (5.8) ] obstructive disease of the gastrointestinal tract [see Warnings and Precautions (5.5) ] severe ulcerative colitis [see Warnings and Precautions (5.7) ] reflux esophagitis Infants less than 6 months of age ( 4 ) Nursing mothers ( 4 ) Unstable cardiovascular status in acute hemorrhage ( 4 ) Myasthenia gravis ( 4 ) Glaucoma ( 4 ) Obstructive uropathy ( 4 ) Obstructive disease of the gastrointestinal tract ( 4 ) Severe ulcerative colitis ( 4 ) Reflux esophagitis ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cardiovascular conditions : worsening of conditions ( 5.2 ) Peripheral and central nervous system : heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted ( 5.3 ) Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness): signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine ( 5.3 ) Myasthenia Gravis : overdose may lead to muscular weakness and paralysis.

Dicyclomine should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase ( 5.4 ) Incomplete intestinal obstruction : diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with dicyclomine would be inappropriate and possibly fatal ( 5.5 ) Salmonella dysenteric patients : due to risk of toxic megacolon ( 5.6 ) Ulcerative colitis : Dicyclomine should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon ( 5.7 ) Prostatic hypertrophy : Dicyclomine should be used with caution in these patients; may lead to urinary retention ( 5.8 ) Hepatic and renal disease : should be used with caution ( 5.9 ) Geriatric : use with caution in elderly who may be more susceptible to dicyclomine’s adverse events ( 5.10 )

5.2Cardiovascular Conditions Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of dicyclomine hydrochloride. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension [see Adverse Reactions (6.3) ].

5.3Peripheral and Central Nervous System The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [see Adverse Reactions (6) ].

In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted.

Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. Central nervous system (CNS) signs and symptoms include confusional state, disorientation, amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms and inappropriate affect. Psychosis and delirium have been reported in sensitive individuals (such as elderly patients and/ or in patients with mental illness) given anticholinergic drugs.

These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug. Dicyclomine may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking dicyclomine.

5.4Myasthenia Gravis With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscul… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The pattern of adverse effects seen with dicylomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology (12) ]. They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued.

The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [see Warnings and Precautions (5.2 , 5.3) ]. The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (> 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg 4 times a day).

In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients. Table 1 presents adverse reactions ( MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo. Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency MedDRA Preferred Term Dicyclomine Hydrochloride (40 mg four times a day) % Placebo % Dry Mouth 33 5 Dizziness 40 5 Vision Blurred 27 2 Nausea 14 6 Somnolence 9 1 Asthenia 7 1 Nervousness 6 2 Nine percent (9%) of patients were discontinued from dicyclomine because of one or more of these side effects (compared with 2% in the placebo group).

In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated.

6.2Postmarketing Experience The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of dicyclomine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders: palpitations, tachyarrhythmias Eye Disorders: cycloplegia, mydriasis, vision blurred Gastrointestinal Disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting General Disorders and Administration Site Conditions: fatigue, malaise Immune System Disorders: drug hypersensitivity including face edema, angioedema, anaphylactic shock Nervous System Disorders: dizziness, headache, somnolence, syncope Psychiatric Disorders: As with the other anticholinergic drugs, cases of delirium or symptoms of delirium such as amnesia (or transient global amnesia), agitation, confusional state, delusion, disorientation, hallucination (including visual hallucination) as well as mania, mood altered and pseudodementia, have been reported with the use of dicyclomine.

Nervousness and insomnia have also been reported. Reproductive System and Breast Disorders: suppressed lactation Respiratory, Thoracic and Mediastinal Disorders: dyspnoea, nasal congestion Skin and Subcutaneous Tissue Disorder: dermatitis al… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Antiglaucoma agents : anticholinergics antagonize antiglaucoma agents and may increase intraoccular pressure ( 7 ) Anticholinergic agents : may affect the gastrointestinal absorption of various drugs; may also increase certain actions or side effects of other anticholinergic drugs ( 7 ) Antacids : interfere with the absorption of anticholinergic agents ( 7 )

7.1Antiglaucoma Agents Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of dicyclomine in patients with glaucoma is not recommended [see Contraindications (4) ].

7.2Other Drugs with Anticholinergic Activity The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants and other drugs having anticholinergic activity.

7.3Other Gastrointestinal Motility Drugs Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.

7.4Effect of Antacids Because antacids may interfere with the absorption of anticholinergic agents including dicyclomine, simultaneous use of these drugs should be avoided.

7.5Effect on Absorption of Other Drugs Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting on gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.

7.6Effect on Gastric Acid Secretion The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: use only if clearly needed ( 8.1 ) Pediatric Use: Safety and effectiveness not established ( 8.4 ) Hepatic and renal impairment: caution must be taken with patients with significantly impaired hepatic and renal function ( 8.6 )

8.1Pregnancy Pregnancy Category B: Adequate and well-controlled studies have not been conducted with dicyclomine in pregnant women at the recommended doses of 80 mg/day to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.3Nursing Mothers Dicyclomine is contraindicated in women who are breastfeeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants from dicyclomine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother [see Use in Specific Populations (8.4) ].

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Dicyclomine is contraindicated in infants less than 6 months of age [see Contraindications (4) ]. There are published cases reporting that the administration of dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma and death, however; no causal relationship has been established.

8.5Geriatric Use Clinical studies of dicyclomine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range in adults, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6Renal Impairment Effects of renal impairment on PK, safety and efficacy of dicyclomine have not been studied. Dicyclomine drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dicyclomine should be administered with caution in patients with renal impairment.

8.7Hepatic Impairment Effects of renal impairment on PK, safety and efficacy of dicyclomine have not been studied. Dicyclomine should be administered with caution in patients with hepatic impairment.

🤰 Pregnancy 124 words ▾

8.1Pregnancy Pregnancy Category B: Adequate and well-controlled studies have not been conducted with dicyclomine in pregnant women at the recommended doses of 80 mg/day to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to dicyclomine.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 76 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Dicyclomine is contraindicated in infants less than 6 months of age [see Contraindications (4) ]. There are published cases reporting that the administration of dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma and death, however; no causal relationship has been established.

🧓 Geriatric Use 112 words ▾

8.5Geriatric Use Clinical studies of dicyclomine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range in adults, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room. The signs and symptoms of overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

One reported event included a 37 year old who reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth and nervousness following ingestion of 320 mg daily (four 20 mg tablets 4 times daily). These events resolved after discontinuing the dicyclomine. The acute oral LD 50 of the drug is 625 mg/kg in mice.

The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10 month old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride [see Warnings and Precautions (5.1) ], the blood concentrations of drug were 200 ng/mL, 220 ng/mL, and 505 ng/mL.

It is not known if dicyclomine is dialyzable. Treatment should consist of gastric lavage, emetics and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement.

If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine ( in vitro , guinea pig ileum); and a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine’s antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum.

Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl 2 )-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl 2 . Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.

12.2Pharmacodynamics Dicyclomine can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate and depress motor function.

12.3Pharmacokinetics Absorption and Distribution: In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60 to 90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately

3.65L/kg suggesting extensive distribution in tissues. Elimination: The metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose).

Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life.

🧬 Mechanism of Action 152 words ▾

12.1Mechanism of Action Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine ( in vitro , guinea pig ileum); and a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine’s antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum.

Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl 2 )-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl 2 . Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.

📦 How Supplied / Storage and Handling 121 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dicyclomine Hydrochloride Capsules, USP are available containing 10 mg of dicyclomine hydrochloride, USP. The 10 mg capsules are a hard-shell gelatin capsule with a No. 4, light turquoise blue opaque cap and light turquoise blue opaque body, hard-shell gelatin capsule filled with a white to off-white powder.

The capsule is axially printed with ‘DIL’ on cap and ‘10’ on body in black ink. They are available as follows: Bottles of 100 capsules NDC 59651-719-01 Bottles of 1000 capsules NDC 59651-719-99 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] To prevent fading, avoid exposure to direct sunlight. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📋 Description 121 words ▾

11 DESCRIPTION Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylicn acid, 2-(diethylamino) ethyl ester, hydrochloride with the following structural formula, molecular weight, and molecular formula: Dicyclomine hydrochloride, USP occurs as a white crystalline powder. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.

Dicyclomine hydrochloride capsules, USP for oral administration, contain 10 mg of dicyclomine hydrochloride, USP. Each capsule contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, FD&C Blue No. 1, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and sodium lauryl sulfate and titanium dioxide.

The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac. Chemical Formula

💬 Information for Patients 165 words ▾

17 PATIENT COUNSELING INFORMATION

17.2Use in Infants Inform parents and caregivers not to administer dicyclomine in infants less than 6 months of age [see Use in Specific Populations (8.4) ].

17.3Use in Nursing Mothers Advise lactating women that dicyclomine should not be used while breastfeeding their infants [see Use in Specific Populations (8.3 , 8.4) ].

17.4Peripheral and Central Nervous System In the presence of a high environmental temperature, heat prostration can occur with dicyclomine use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Dicyclomine may produce drowsiness or blurred vision.

The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking dicyclomine [see Warnings and Precautions (5.3) ]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 05/2023

🍼 Nursing Mothers 63 words ▾

8.3Nursing Mothers Dicyclomine is contraindicated in women who are breastfeeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants from dicyclomine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother [see Use in Specific Populations (8.4) ].

🧬 Pharmacokinetics 128 words ▾

12.3Pharmacokinetics Absorption and Distribution: In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60 to 90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately

3.65L/kg suggesting extensive distribution in tissues. Elimination: The metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose).

Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life.

🧬 Pharmacodynamics 28 words ▾

12.2Pharmacodynamics Dicyclomine can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate and depress motor function.

🔬 Clinical Studies 52 words ▾

14 CLINICAL STUDIES In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg 4 times daily) demonstrated a favorable clinical response compared with 55% treated with placebo (p < 0.05).

🧪 Nonclinical Toxicology 44 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of dicyclomine. In studies in rats at doses of up to 100 mg/kg/day, dicyclomine produced no deleterious effects on breeding, conception or parturition.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 41 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of dicyclomine. In studies in rats at doses of up to 100 mg/kg/day, dicyclomine produced no deleterious effects on breeding, conception or parturition.

📄 Package Label / Principal Display Panel 33 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (100 Capsules Bottle) NDC 59651-719-01 Dicyclomine Hydrochloride Capsules, USP 10 mg Rx only 100 Capsules AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (100 Tablet Bottle)

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
189.8K
Units reimbursed last 4 qtrs
14.3M
Gross reimbursed last 4 qtrs
$2.46M
Avg / prescription
$12.96
Avg / unit
$0.1716
Latest quarter Q4 2025
41.7KRx
Medicaid pays / ea
$0.1716
gross reimbursed
vs
NADAC / ea
$0.0778
acquisition cost
=
Spread
+$0.0938
+121% 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 ⓘ
28% FFS 72% MCO
Fee-for-service · 52,598 Rx Managed care · 137,232 Rx
State Medicaid map
Alaska: 1,850 units · 252 per 100k residents AK Maine: 99,559 units · 7,137 per 100k residents ME Washington: 182,904 units · 2,341 per 100k residents WA Idaho: 72,019 units · 3,667 per 100k residents ID Montana: 23,435 units · 2,070 per 100k residents MT North Dakota: 10,914 units · 1,394 per 100k residents ND Minnesota: 155,016 units · 2,702 per 100k residents MN Wisconsin: 253,510 units · 4,290 per 100k residents WI Michigan: 625,379 units · 6,231 per 100k residents MI New York: 886,787 units · 4,531 per 100k residents NY Vermont: 14,741 units · 2,278 per 100k residents VT New Hampshire: 48,904 units · 3,488 per 100k residents NH Oregon: 199,393 units · 4,710 per 100k residents OR Nevada: 86,286 units · 2,702 per 100k residents NV Wyoming: 7,527 units · 1,289 per 100k residents WY South Dakota: 20,172 units · 2,195 per 100k residents SD Iowa: 114,035 units · 3,556 per 100k residents IA Illinois: 752,667 units · 5,998 per 100k residents IL Indiana: 1,208,227 units · 17,608 per 100k residents IN Ohio: 1,369,885 units · 11,624 per 100k residents OH Pennsylvania: 1,432,408 units · 11,052 per 100k residents PA New Jersey: 570,429 units · 6,140 per 100k residents NJ Massachusetts: 110,731 units · 1,582 per 100k residents MA California: 542,987 units · 1,394 per 100k residents CA Utah: 54,401 units · 1,592 per 100k residents UT Colorado: 219,305 units · 3,731 per 100k residents CO Nebraska: 76,538 units · 3,869 per 100k residents NE Missouri: 638,094 units · 10,298 per 100k residents MO Kentucky: 445,889 units · 9,852 per 100k residents KY West Virginia: 289,469 units · 16,354 per 100k residents WV Virginia: 387,281 units · 4,443 per 100k residents VA Maryland: 285,425 units · 4,619 per 100k residents MD Connecticut: 143,318 units · 3,962 per 100k residents CT Rhode Island: 20,804 units · 1,900 per 100k residents RI Arizona: 204,086 units · 2,746 per 100k residents AZ New Mexico: 154,406 units · 7,304 per 100k residents NM Kansas: 54,561 units · 1,856 per 100k residents KS Arkansas: 78,168 units · 2,549 per 100k residents AR Tennessee: 243,576 units · 3,418 per 100k residents TN North Carolina: 573,128 units · 5,290 per 100k residents NC South Carolina: 106,998 units · 1,991 per 100k residents SC Delaware: 67,526 units · 6,550 per 100k residents DE Oklahoma: 172,491 units · 4,256 per 100k residents OK Louisiana: 346,942 units · 7,585 per 100k residents LA Mississippi: 79,932 units · 2,719 per 100k residents MS Alabama: 121,731 units · 2,383 per 100k residents AL Georgia: 190,545 units · 1,728 per 100k residents GA D.C.: 6,540 units · 963 per 100k residents DC Hawaii: 3,137 units · 219 per 100k residents HI Texas: 249,075 units · 817 per 100k residents TX Florida: 308,462 units · 1,364 per 100k residents FL
Units reimbursed · per 100k residents
21917,608
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 Indiana 17,608 /100k
2 West Virginia 16,354 /100k
3 Ohio 11,624 /100k
4 Pennsylvania 11,052 /100k
5 Missouri 10,298 /100k
6 Kentucky 9,852 /100k
7 Louisiana 7,585 /100k
8 New Mexico 7,304 /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 page59651-0719-01 189,830 Rx · $2,460,694
1000 capsules59651-0719-99 51,099 Rx · $665,413
Drug total (last 4 qtrs): 240,929 Rx · 17,878,275 units · $3,126,108 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 59651-0717-61 · Aurobindo 59651-0720-01 · Aurobindo →
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.