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Oxybutynin Chloride 5 mg Tablet, 100-count — NDC 70954-0005-10 package photo

Oxybutynin Chloride 5 mg Tablet, 100-count

by ANI Pharmaceuticals, Inc. · 100 TABLET in 1 BOTTLE (70954-005-10)
NDC 70954-0005-10
🏷️ FDA NDC (as labeled) 70954-005-10 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0473 NADAC Per package$4.73 / 100 tablets Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.1554/unit · Part D plans $0.1412/unit — full pricing hub ↓
Also comes in: 100 tablets 70954-0005-50 500 tablets 70954-0005-20 1000 tablets 70954-0005-30
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 70954-005-10
Product NDC 70954-005
11-digit billing NDC 70954000510
NCPDP billing unit EA — each (per item)
RxCUI 863664
UNII L9F3D9RENQ
UPC 0370954005308, 0370954005100, 0370954005209
Application # ANDA209823
SPL Set ID 3b1f5585-9b33-4a96-bf33-8e6bab14bf0c
Established class (EPC) Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-11-15
Route ORAL
Dosage form TABLET
Substance OXYBUTYNIN CHLORIDE
GPI-14 54100045200330
GPI class Oxybutynin Chloride
GCN Seq No 004929
GCN 19380
HICL code 002048
Ingredient (HICL) Oxybutynin Chloride
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1A
Therapeutic class — specific (HIC3) Urinary Tract Antispasmodic/Antiincontinence Agent
AHFS code 86:12.04.00
AHFS class Antimuscarinics
FDB label name OXYBUTYNIN 5 MG TABLET
FDB brand name Oxybutynin Chloride
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70954-005-10 — 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 → 70954-0005-10. 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 Cholinergic Muscarinic Antagonist class.

Pharmacologic class Cholinergic Muscarinic Antagonist
Drug family (ATC) Drugs for urinary frequency and incontinence
How it works Cholinergic Muscarinic 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.

🏭 Manufacturer & labeler

LabelerANI Pharmaceuticals, Inc.
Application holderNOVITIUM PHARMA LLC
FDA applicationANDA209823 (ANDA)
Labeler code70954
First marketedNov 2017
Product typeHuman Prescription Drug
Portfolio299 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name OXYBUTYNIN 5 MG TABLET Ingredient Oxybutynin Chloride
📖 What it is MedlinePlus · NLM

Oxybutynin is used to treat overactive bladder (a bladder condition that causes sudden urges to urinate that may be hard to control) and to control bladder muscles weakened in certain nerve conditions. Oxybutynin is in a class of medications called anticholinergics/antimuscarinics. It works by relaxing the bladder muscles.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Oxybutynin calms down an overactive bladder by relaxing the bladder muscle and reducing those sudden, hard-to-ignore urges to go. Over time, most people find they have fewer urgent...
  • What exactly is oxybutynin supposed to do for me?
  • Yes, dry mouth is the most common side effect of oxybutynin — and it's more noticeable with the immediate-release tablets than the extended-release form. Sipping water throughout t...
  • My mouth is incredibly dry since starting this — is that normal?
📖 Read our full Oxybutynin 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.

💊 What it looks like

Color White
ShapeRound
Imprintn005
Size8 mm
ScoringScored — splits in 2
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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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.

4 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.

💲 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 $0.047 $4.73 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1554 $15.54 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1412 $14.12 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.079 $0.046
▼ Down 34% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxybutynin Chloride 5 mg 00832-0038-00 Upsher-Smith 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 00904-7027-61 Major 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 10702-0201-01 KVK-Tech, 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 23155-0810-01 Heritage 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 50111-0456-01 Teva 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 52817-0260-10 TruPharma 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 60687-0899-01 American 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 64380-0162-01 Strides 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 64980-0431-01 RISING 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 69315-0182-01 Leading 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mgthis 70954-0005-10 ANI 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 00615-8492-05 NCS 15 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 23155-0913-01 Heritage 100 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 42291-0456-50 AvKARE 500 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 43063-0851-01 PD-Rx 100 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 43063-0931-30 PD-Rx 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 43353-0978-92 Aphena 270 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-4622-00 A-S 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-6199-00 A-S 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-6638-00 A-S 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-6966-00 A-S 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-6967-00 A-S 90 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-7766-00 A-S 90 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 51407-0099-01 Golden 100 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 51655-0665-25 Northwind 60 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 55154-2632-00 Cardinal 10 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 63187-0749-30 Proficient 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 64380-0781-03 Strides 60 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 64980-0679-01 RISING 100 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 66267-0642-30 NuCare 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 67296-2045-03 Redpharm 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 68788-8141-09 Preferred 90 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 70518-2640-00 REMEDYREPACK 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 71335-0519-01 Bryant 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 71335-1014-01 Bryant 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 71335-1494-01 Bryant 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 71610-0277-53 Aphena 60 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 71610-0394-53 Aphena 60 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 71610-0860-30 Aphena 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 72189-0130-30 direct 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 72789-0417-30 PD-Rx 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 72789-0490-60 PD-Rx 60 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 82868-0047-30 Northwind 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 83939-0022-01 VERITYRX, 1 tablet — AB FDA listed —
Oxybutynin Chloride 5 mg 67046-1381-03 Coupler 30 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

🏛️
2017
On the market since
Nov 2017
📍
2026
Currently FDA-listed
9 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.

🗺️ 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 70954-0005-10, 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
44.3K
Units reimbursed last 4 qtrs
3.1M
Gross reimbursed last 4 qtrs
$485.8K
Avg / prescription
$10.96
Avg / unit
$0.1554
Latest quarter Q4 2025
8.9KRx
Medicaid pays / ea
$0.1554
gross reimbursed
vs
NADAC / ea
$0.0473
acquisition cost
=
Spread
+$0.1081
+229% 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 ⓘ
44% FFS 56% MCO
Fee-for-service · 19,510 Rx Managed care · 24,795 Rx
State Medicaid map
Alaska: 5,498 units · 750 per 100k residents AK Maine: 20,918 units · 1,499 per 100k residents ME Washington: 165,911 units · 2,124 per 100k residents WA Idaho: 24,385 units · 1,242 per 100k residents ID Montana: 28,839 units · 2,548 per 100k residents MT North Dakota: 7,654 units · 978 per 100k residents ND Minnesota: 57,107 units · 995 per 100k residents MN Wisconsin: 53,757 units · 910 per 100k residents WI Michigan: 48,062 units · 479 per 100k residents MI New York: 210,224 units · 1,074 per 100k residents NY Vermont: 25,591 units · 3,955 per 100k residents VT New Hampshire: 16,085 units · 1,147 per 100k residents NH Oregon: 122,542 units · 2,895 per 100k residents OR Nevada: 39,568 units · 1,239 per 100k residents NV Wyoming: 5,375 units · 920 per 100k residents WY South Dakota: 5,442 units · 592 per 100k residents SD Iowa: 17,759 units · 554 per 100k residents IA Illinois: 113,174 units · 902 per 100k residents IL Indiana: 68,265 units · 995 per 100k residents IN Ohio: 91,157 units · 774 per 100k residents OH Pennsylvania: 140,415 units · 1,083 per 100k residents PA New Jersey: 27,886 units · 300 per 100k residents NJ Massachusetts: 23,928 units · 342 per 100k residents MA California: 468,237 units · 1,202 per 100k residents CA Utah: 29,941 units · 876 per 100k residents UT Colorado: 89,011 units · 1,514 per 100k residents CO Nebraska: 15,052 units · 761 per 100k residents NE Missouri: 119,357 units · 1,926 per 100k residents MO Kentucky: 82,396 units · 1,821 per 100k residents KY West Virginia: 38,405 units · 2,170 per 100k residents WV Virginia: 83,552 units · 959 per 100k residents VA Maryland: 24,174 units · 391 per 100k residents MD Connecticut: 11,178 units · 309 per 100k residents CT Rhode Island: 1,537 units · 140 per 100k residents RI Arizona: 112,649 units · 1,516 per 100k residents AZ New Mexico: 72,968 units · 3,452 per 100k residents NM Kansas: 25,148 units · 855 per 100k residents KS Arkansas: 37,137 units · 1,211 per 100k residents AR Tennessee: 58,947 units · 827 per 100k residents TN North Carolina: 53,673 units · 495 per 100k residents NC South Carolina: 43,941 units · 818 per 100k residents SC Delaware: 6,985 units · 677 per 100k residents DE Oklahoma: 92,154 units · 2,274 per 100k residents OK Louisiana: 82,916 units · 1,813 per 100k residents LA Mississippi: 32,349 units · 1,100 per 100k residents MS Alabama: 31,131 units · 609 per 100k residents AL Georgia: 67,976 units · 616 per 100k residents GA D.C.: 6,698 units · 986 per 100k residents DC Hawaii: 4,166 units · 290 per 100k residents HI Texas: 82,567 units · 271 per 100k residents TX Florida: 32,501 units · 144 per 100k residents FL
Units reimbursed · per 100k residents
1403,955
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 Vermont 3,955 /100k
2 New Mexico 3,452 /100k
3 Oregon 2,895 /100k
4 Montana 2,548 /100k
5 Oklahoma 2,274 /100k
6 West Virginia 2,170 /100k
7 Washington 2,124 /100k
8 Missouri 1,926 /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.
500 tablets70954-0005-20 73,737 Rx · $802,117
1000 tablets70954-0005-30 60,831 Rx · $682,635
100 tablets this page70954-0005-10 44,305 Rx · $485,782
1 tablet70954-0005-50 No Medicaid data
Drug total (last 4 qtrs): 178,873 Rx · 12,428,752 units · $1,970,533 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 Oxybutynin Chloride — the program that covers self-administered drugs. 12 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 Oxybutynin Chloride. 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
$7.83M
Claims incl. refills
449.3K
Beneficiaries
297K
Spend / beneficiary
$26.37
Spend / claim
$17.43
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Oxybutynin Chloride — the ingredient across all brands.

Top reported reactions

Fatigue729
Nausea602
Fall579
Headache557
Diarrhoea507
Pain481
Urinary Tract Infection446

Reporter sex

8,714 reports
Male · 29%
Female · 71%
Unknown · 0%

Serious outcomes

Hospitalization2,547
Death550
Disabling140
Life-threatening129
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 754 290
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
70954-0005-10 You're viewing this 100 TABLET in 1 BOTTLE (70954-005-10) $0.0473 / ea $4.73 2017-11-15 Active
70954-0005-20 500 TABLET in 1 BOTTLE (70954-005-20) $0.0473 / ea $23.65 2017-11-15 Active
70954-0005-30 1000 TABLET in 1 BOTTLE (70954-005-30) $0.0473 / ea $47.29 2017-11-15 Active
70954-0005-50 100 BLISTER PACK in 1 CARTON (70954-005-50) / 1 TABLET in 1 BLISTER PACK (70954-005-40) — — 2021-08-20 Active

This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.0473 NADAC).

This pack accounts for about 25% of this product's recent Medicaid fills; the largest share goes to the 500 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 70954-0005-10?
NDC 70954-0005-10 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 70954-0005-10 and NDC 70954-0005-50?
Both are Oxybutynin Chloride 5 mg Tablet — the drug itself is identical. NDC 70954-0005-10 is the 100-count package, while NDC 70954-0005-50 is the 100 tablets package.
What NDC number is used to bill for this package of Oxybutynin Chloride 5 mg Tablet?
Bill NDC 70954-0005-10 — the 11-digit billing format is 70954000510. 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.

📄 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 37 words ▾

INDICATIONS & USAGE Oxybutynin chloride tablets, USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).

⏱️ Dosage and Administration 78 words ▾

DOSAGE & ADMINISTRATION Adults The usual dose is one 5-mg tablet two to three times a day. The maximum recommended dose is one 5-mg tablet four times a day. A lower starting dose of 2.5 mg two or three times a day is recommended for the frail elderly. Pediatric patients over 5 years of age The usual dose is one 5-mg tablet two times a day. The maximum recommended dose is one 5-mg tablet three times a day.

⛔ Contraindications 55 words ▾

CONTRAINDICATIONS Oxybutynin chloride tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. Oxybutynin chloride tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

⚠️ Warnings 61 words ▾

WARNINGS Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The safety and efficacy of oxybutynin chloride was evaluated in a total of 199 patients in three clinical trials. These participants were treated with oxybutynin chloride 5 to 20 mg/day for up to 6 weeks. Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to treatment and reported by at least 5% of patients.

Table 3 Incidence (%) of Adverse Events Reported by ≥ 5% of Patients Using Oxybutynin Chloride (5 to 20 mg/day) Body System Adverse Event Oxybutynin Chloride (5 to 20 mg/day) (n=199) Infections and Infestations Urinary tract infection 6.5% Psychiatric Disorders Insomnia 5.5% Nervousness 6.5% Nervous System Disorders Dizziness 16.6% Somnolence 14.0% Headache 7.5% Eye Disorders Blurred vision 9.6% Gastrointestinal Disorders Dry mouth 71.4% Constipation 15.1% Nausea 11.6% Dyspepsia 6.0% Renal and Urinary Disorders Urinary Hesitation 8.5% Urinary Retention 6.0% The most common adverse events reported by patients receiving oxybutynin chloride 5 to 20 mg/day were the expected side effects of anticholinergic agents.

The incidence of dry mouth was dose-related. In addition, the following adverse events were reported by 1 to <5% of patients using oxybutynin chloride (5 to 20 mg/day) in all studies. Infections and Infestations : nasopharyngitis, upper respiratory tract infection, bronchitis, cystitis, fungal infection; Metabolism and Nutrition Disorders : fluid retention; Psychiatric Disorders : confusional state; Nervous System Disorders : dysgeusia, sinus headache; Eye Disorders : kerato conjunctivitis sicca, eye irritation; Cardiac Disorders : palpitations, sinus arrhythmia; Vascular Disorders : flushing; Respiratory, thoracic and Mediastinal Disorders : nasal dryness, cough, pharyngolaryngeal pain, dry throat, sinus congestion, hoarseness, asthma, nasal congestion; Gastrointestinal Disorders : diarrhea, abdominal pain, loose stools, flatulence, vomiting, abdominal pain upper, dysphagia, aptyalism, eructation, tongue coated; Skin and Subcutaneous Tissue Disorders : dry skin, pruritis; Musculoskeletal and Connective Tissue Disorders : back pain, arthralgia, pain in extremity, flank pain; Renal and Urinary Disorders : dysuria, pollakiuria; General Disorders and Administration Site Conditions : fatigue, edema peripheral, asthenia, pain, thirst, edema; Investigations : blood pressure increased, blood glucose increased, blood pressure decreased; Injury, Poisoning, and Procedural Complications : fall.

Postmarketing Surveillance Because postmarketing adverse events 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. The following additional adverse events have been reported from worldwide postmarketing experience with oral oxybutynin chloride: Psychiatric Disorders : psychotic disorder, agitation, hallucinations, memory impairment; Nervous System Disorders : convulsions; Eye Disorders : cycloplegia, mydriasis, glaucoma; Cardiac Disorders : tachycardia, QT interval prolongation, chest discomfort; Gastrointestinal Disorders : decreased gastrointestinal motility, frequent bowel movements; Skin and Subcutaneous Tissue Disorders : rash, decreased sweating; Renal and Urinary Disorders : impotence; Reproductive System and Breast Disorders : Suppression of lactation; General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment; Metabolism and Nutrition Disorders : anorexia; Respiratory, Thoracic and Mediastinal Disorders : dysphonia.

🔄 Drug Interactions 155 words ▾

Drug Interactions The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index.

Anticholinergic agents may also antagonize the effects of prokinetic agents, such as metoclopramide. Mean oxybutynin chloride plasma concentrations were approximately 3 to 4 fold higher when oxybutynin was administered with ketoconazole, a potent CYP3A4 inhibitor. Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C max and AUC).

The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered.

🤰 Pregnancy 75 words ▾

Pregnancy Teratogenic Effects Category B. Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility or harm to the animal fetus. The safety of oxybutynin chloride administered to women who are or who may become pregnant has not been established.

Therefore, oxybutynin chloride should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.

🧒 Pediatric Use ~1 min read ▾

Pediatric Use The safety and efficacy of oxybutynin chloride administration have been demonstrated for pediatric patients 5 years of age and older (see DOSAGE AND ADMINISTRATION ). The safety and efficacy of oxybutynin chloride tablets were studied in 30 children in a 24 week, open-label trial. Patients were aged 5 to 15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride.

Study results demonstrated that the administration of oxybutynin chloride was associated with improvement in clinical and urodynamic parameters. At total daily doses ranging from 5 mg to 15 mg, treatment with oxybutynin chloride tablets was associated with an increase from baseline in mean urine volume per catheterization from 122 mL to 145 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 168 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 43% to 61%.

Urodynamic results in these patients were consistent with the clinical results. Treatment with oxybutynin chloride tablets was associated with an increase from baseline in maximum cystometric capacity from 230 mL to 279 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 36 cm H 2 O to 33 cm H 2 O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H 2 O) from 39% to 20%. As there is insufficient clinical data for pediatric populations under age 5, oxybutynin chloride is not recommended for this age group.

🧓 Geriatric Use 124 words ▾

Geriatric Use Clinical studies of oxybutynin chloride did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between healthy elderly and younger patients; however, a lower initial starting dose of 2.5 mg given 2 or 3 times a day has been recommended for the frail elderly due to a prolongation of the elimination half-life from 2 to 3 hours to 5 hours . 2,3,4 In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 112 words ▾

OVERDOSAGE Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be administered. Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation (e.g., restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.

Other symptoms may include hypotension or hypertension, respiratory failure, paralysis, and coma. Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients fully recovered with symptomatic treatment.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. Oxybutynin chloride exhibits only one fifth of the anticholinergic activity of atropine on the rabbit detrusor muscle, but four to ten times the antispasmodic activity. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects).

Oxybutynin chloride relaxes bladder smooth muscle. In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin chloride increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void. Oxybutynin chloride thus decreases urgency and the frequency of both incontinent episodes and voluntary urination.

Antimuscarinic activity resides predominately in the R-isomer. A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in in vitro studies. Pharmacokinetics Absorption Following oral administration of oxybutynin chloride tablets, oxybutynin is rapidly absorbed achieving C max within an hour, following which plasma concentration decreases with an effective half-life of approximately 2 to 3 hours.

The absolute bioavailability of oxybutynin is reported to be about 6% (range 1.6 to 10.9%) for the tablets. Wide interindividual variation in pharmacokinetic parameters is evident following oral administration of oxybutynin. The mean pharmacokinetic parameters for R- and S-oxybutynin are summarized in Table 1 .

The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for R-oxybutynin. Table 1 Mean (SD) R-and S-Oxybutynin Pharmacokinetic Parameters Following Three Doses of Oxybutynin Chloride 5 mg Administered every 8 Hours (n=23) Parameters (units) R-Oxybutynin S-Oxybutynin C max (ng/mL) 3.6 (2.2) 7.8 (4.1) T max (h) 0.89 (0.34) 0.65 (0.32) AUC t (ng•h/mL) 22.6 (11.3) 35.0 (17.3) AUC inf (ng•h/mL) 24.3 (12.3) 37.3 (18.7) Figure 1 . Mean R-Oxybutynin Plasma Concentrations Following Three Doses of Oxybutynin Chloride 5 mg Administered Every 8 Hours for 1 Day in 23 Healthy Adult Volunteers.

Oxybutynin chloride steady-state pharmacokinetics were also studied in 11 pediatric patients with detrusor overactivity associated with a neurological condition (e.g., spina bifida). These pediatric patients were on oxybutynin chloride tablets with total daily dose ranging from 7.5 mg to 15 mg (0.22 to 0.53 mg/kg). Overall, most patients (86.9%) were taking a total daily oxybutynin chloride dose between 10 mg and 15 mg.

Sparse sampling technique was used to obtain serum samples. When all available data are normalized to an equivalent of 5 mg twice daily oxybutynin chloride, the mean pharmacokinetic parameters derived for R- and S-oxybutynin and R- and S-desethyloxybutynin are summarized in Table 2 . The plasma-time concentration profiles for R- and S-oxybutynin are similar in shape; Figure 2 shows the profile for R-oxybutynin when all available data are normalized to an equivalent of 5 mg twice daily.

Table 2 Mean ± SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters in Children Aged 5 to 15 Following Administration of 7.5 mg to 15 mg Total Daily Dose of Oxybutynin Chloride Tablets (N=11) All Available Data Normalized to an Equivalent of Oxybutynin Chloride Tablets 5 mg BID or TID at Steady State R-Oxybutynin S-Oxybutynin R-Desethyloxybutynin S-Desethyloxybutynin C max * (ng/mL) 6.1 ± 3.2 10.1 ± 7.5 55.4 ± 17.9 28.2 ±

10.0T max (hr) 1.0 1.0 2.0

2.0AUC † (ng•hr/mL) 19.8 ± 7.4 28.4 ± 12.7 238.8 ± 77.6 119.5 ± 50.7 *Reflects C max for pooled data † AUC 0-end of dosing interval Figure 2 . Mean steady-state (±SD) R-oxybutynin plasma concentrations following administration of total daily Oxybutynin Chloride Tablet dose of 7.5 mg to 15 mg (0.22 mg/kg…

📦 How Supplied / Storage and Handling 94 words ▾

HOW SUPPLIED Oxybutynin Chloride Tablets, USP 5 mg are white, round, biconvex tablets debossed with “n005” on one side and bisect on the other side. They are supplied as follows: NDC 70954- 005 -10 Bottles of 100 Tablets NDC 70954- 005 -20 Bottles of 500 Tablets NDC 70954- 005- 30 Bottles of 1000 Tablets NDC 70954- 005- 50 Unit dose blister packages of 100 (10 cards of 10 tablets each) Pharmacist: Dispense in tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 101 words ▾

DESCRIPTION Each scored oxybutynin chloride tablet, USP contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d, l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The molecular formula of oxybutynin chloride is C 22 H 31 NO 3 •HCl.

The structural formula appears below: Oxybutynin chloride, USP is a white crystalline solid with a molecular weight of 393.95. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride Tablets, USP also contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose.

Oxybutynin chloride tablets, USP are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. Meets USP Dissolution Test 2.

STRUCTURE

💬 Information for Patients 116 words ▾

Information for Patients Patients should be informed that oxybutynin may produce angioedema that could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing. Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin chloride are administered in the presence of high environmental temperature.

Because anticholinergic agents such as oxybutynin may produce drowsiness (somnolence), or blurred vision, patients should be advised to exercise caution. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70952-0009-01 · Jiangsu 70954-0014-10 · ANI →
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.