HomeNDC LookupIngredientsOrphenadrine Citrate › 00185-0022-01
Orphenadrine Citrate 100 mg Tablet, Extended Release, 100-count — NDC 00185-0022-01 package photo

Orphenadrine Citrate 100 mg Tablet, Extended Release, 100-count

by Sandoz Inc · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0022-01)
NDC 00185-0022-01
🏷️ FDA NDC (as labeled) 0185-0022-01 billing pads the labeler segment with a zero
This package
Contains100-count Cost per ea$0.4586 NADAC Per package$45.86 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.4680/unit · Part D plans $0.7752/unit — full pricing hub ↓
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 →
Past resolved recalls for this product (1)
Class II · Mar 21, 2022 · Terminated — CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. (Sandoz, Inc) · FDA recall D-0753-2022

🆔 Identity & classification

FDA NDC (as labeled) 0185-0022-01
Product NDC 0185-0022
11-digit billing NDC 00185002201
NCPDP billing unit EA — each (per item)
RxCUI 994521
UNII X0A40N8I4S
Application # ANDA040327
SPL Set ID 239018ff-cec6-46de-ae9d-26c9ec034a32
Established class (EPC) Muscle Relaxant
Physiologic effect Centrally-mediated Muscle Relaxation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-02-15
Marketing end 2027-03-20
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance ORPHENADRINE CITRATE
GPI-14 75100080107410
GPI class Orphenadrine Citrate ER
GCN Seq No 004595
GCN 17670
HICL code 001906
Ingredient (HICL) Orphenadrine Citrate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6H
Therapeutic class — specific (HIC3) Skeletal Muscle Relaxants
AHFS code 12:20.10.00
AHFS class Indirect-Acting Skeletal Muscle Relaxant
FDB label name ORPHENADRINE ER 100 MG TABLET
FDB brand name Orphenadrine Citrate Er
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 0185-0022-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00185-0022-01. 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 Muscle Relaxant class.

Pharmacologic class Muscle Relaxant
Drug family (ATC) Ethers chemically close to antihistamines, Ethers, chemically close to antihistamines
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

LabelerSandoz Inc
Application holderSANDOZ INC
FDA applicationANDA040327 (ANDA)
Labeler code00185
First marketedFeb 2000
Product typeHuman Prescription Drug
Portfolio387 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 ORPHENADRINE ER 100 MG TABLET Ingredient Orphenadrine Citrate
📖 What it is MedlinePlus · NLM

Orphenadrine is used with rest, physical therapy, and other measures to relieve pain and discomfort caused by strains, sprains, and other muscle injuries. Orphenadrine is in a class of medications called skeletal muscle relaxants. It works by changing the way the body senses muscle pain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's a common assumption, but orphenadrine actually doesn't directly relax tense muscles. Researchers believe its benefit comes from pain-relieving properties — so it helps you fee...
  • What exactly does orphenadrine do — does it just relax my muscles?
  • Take one extended-release tablet in the morning and one in the evening — that's twice a day. Try to stick to the same times each day. If you're unsure whether to take it with food...
  • How should I take the extended-release tablet?
📖 Read our full Orphenadrine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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 776XM7047L
    Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.

3 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 DailyMedingredient 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 $0.459 $45.86 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.4680 $46.80 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.7752 $77.52 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.536 $0.288
▲ Up 59% 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
Orphenadrine Citrate 100 mgthis 00185-0022-01 Sandoz 100 tablets $0.459 AB Availability likely
Orphenadrine Citrate 100 mg 43386-0480-24 Lupin 100 tablets $0.459 AB Availability likely
Orphenadrine Citrate 100 mg 43063-0407-14 PD-Rx 14 tablets AB FDA listed
Orphenadrine Citrate 100 mg 49999-0046-14 Lake 14 tablets AB Discontinued
Orphenadrine Citrate 100 mg 50090-0169-00 A-S 20 tablets AB FDA listed
Orphenadrine Citrate 100 mg 60760-0810-30 St. 30 tablets AB FDA listed
Orphenadrine Citrate 100 mg 63187-0122-20 Proficient 20 tablets AB FDA listed
Orphenadrine Citrate 100 mg 63187-0632-30 Proficient 30 tablets AB FDA listed
Orphenadrine Citrate 100 mg 63629-1564-00 Bryant 56 tablets AB FDA listed
Orphenadrine Citrate 100 mg 66267-0158-20 NuCare 20 tablets AB FDA listed
Orphenadrine Citrate 100 mg 67296-1077-01 RedPharm 10 tablets AB FDA listed
Orphenadrine Citrate 100 mg 68788-9138-01 Preferred 100 tablets AB FDA listed
Orphenadrine Citrate 100 mg 70518-4506-00 REMEDYREPACK 14 tablets AB FDA listed
Orphenadrine Citrate 100 mg 72162-2020-01 Bryant 100 tablets AB FDA listed
Orphenadrine Citrate ER 100 mg 80425-0117-01 Advanced 30 tablets AB FDA listed
Orphenadrine Citrate 100 mg 80425-0340-01 Advanced 30 tablets AB FDA listed
Orphenadrine Citrate 100 mg 82868-0040-14 Northwind 14 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

🏛️
2000
On the market since
Feb 2000
📍
2026
Currently FDA-listed
26 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 00185-0022-01, 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
37
Units reimbursed last 4 qtrs
1.6K
Gross reimbursed last 4 qtrs
$739.48
Avg / prescription
$19.99
Avg / unit
$0.4680
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$0.4680
gross reimbursed
vs
NADAC / ea
$0.4586
acquisition cost
=
Spread
+$0.0094
+2% 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
100% MCO
Fee-for-service · 0 Rx Managed care · 37 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 635 units · 6.3 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 495 units · 10.9 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 450 units · 11.1 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
6.311.1
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 Oklahoma 11.1 /100k
2 Kentucky 10.9 /100k
3 Michigan 6.3 /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.
Drug total (last 4 qtrs): 37 Rx · 1,580 units · $739 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 Orphenadrine Citrate — the program that covers self-administered drugs. 3 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 Orphenadrine Citrate. 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
$43.5K
Claims incl. refills
881
Beneficiaries
744
Spend / beneficiary
$58.44
Spend / claim
$49.36
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 ORPHENADRINE CITRATE — the ingredient across all brands.

Top reported reactions

Nausea69
Pain69
Fatigue58
Headache52
Anxiety50
Dizziness46
Arthralgia44

Age at onset

Adult66
Elderly15

Reporter sex

748 reports
Male · 24%
Female · 75%
Unknown · 1%

Serious outcomes

Hospitalization212
Life-threatening24
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 31 0
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
00185-0022-01 You're viewing this 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0022-01) $0.4586 / ea $45.86 2000-02-15 Active
00185-0022-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0022-10) $0.5364 / ea $536.42 2000-02-15 Discontinued by firm

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 ($0.4586 NADAC).

Pack size FAQ

What quantity is in NDC 00185-0022-01?
NDC 00185-0022-01 is a 100-count package — 100 tablet, extended release in 1 bottle.
What is the difference between NDC 00185-0022-01 and NDC 00185-0022-10?
Both are Orphenadrine Citrate 100 mg Tablet, Extended Release — the drug itself is identical. NDC 00185-0022-01 is the 100-count package, while NDC 00185-0022-10 is the 1000 tablets package. Per-ea NADAC also differs: $0.4586 here vs $0.5364 for the 1000 tablets pack.
What NDC number is used to bill for this package of Orphenadrine Citrate 100 mg Tablet, Extended Release?
Bill NDC 00185-0022-01 — the 11-digit billing format is 00185002201. 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 31 words

INDICATIONS AND USAGE Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions.

⏱️ Dosage and Administration 16 words

DOSAGE AND ADMINISTRATION Adults-Two tablets per day; one in the morning and one in the evening.

Contraindications 38 words

CONTRAINDICATIONS Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (megaesophagus) and myasthenia gravis. Contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

⚠️ Warnings 43 words

WARNINGS Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine citrate may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.

🤒 Adverse Reactions 142 words

ADVERSE REACTIONS Adverse reactions of orphenadrine citrate are mainly due to the mild anti-cholinergic action of orphenadrine citrate and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation and rarely urticaria and other dermatoses.

Infrequently, an elderly patient may experience some degree of mental confusion. These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported.

No causal relationship has been established. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 47 words

PREGNANCY Animal reproduction studies have not been conducted with orphenadrine citrate. It is also not known whether orphenadrine citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine citrate should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 12 words

PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 71 words

OVERDOSAGE Orphenadrine citrate is toxic when overdosed and typically induces anticholinergic effects. [3] In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2 to 3 grams for adults; however, the range of toxicity is variable and unpredictable. [4] Treatment for orphenadrine citrate overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring and appropriate supportive treatment of any emergent anticholinergic effects. [5]

📦 How Supplied / Storage and Handling 99 words

HOW SUPPLIED Orphenadrine Citrate Extended-Release Tablets, USP, for oral administration, are available as 100 mg White, round-shaped tablets debossed “ E ” over “22” on one side and plain on the other side and supplied as: NDC 0185-0022-01 bottles of 100 NDC 0185-0022-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP TIGHTLY CLOSED.

KEEP OUT OF THE REACH OF CHILDREN. Manufactured by Sandoz Inc. Princeton, NJ 08540 46299664 Rev.

May 2022 MF0022REV05/2022

📋 Description 92 words

DESCRIPTION Orphenadrine citrate, USP is the citrate salt of orphenadrine (2-dimethyl-aminoethyl 2-methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol and has a molecular weight of 461.51.

The molecular formula C 18 H 23 NO • C 6 H 8 O 7 is represented by the following structural formula: Each orphenadrine citrate extended-release tablet, USP contains 100 mg orphenadrine citrate, USP. Orphenadrine citrate extended-release tablets, USP also contain: calcium stearate, ethylcellulose and lactose monohydrate. Image-01

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