Orphenadrine Citrate 100 mg Tablet, Extended Release, 100-count — NDC 0185-0022-01 (Billing 00185-0022-01)
This is a package of 100 tablets of Orphenadrine Citrate 100 mg Tablet, Extended Release from Sandoz Inc, marketed since Feb 2000 and currently FDA-listed, this package's marketing is listed to end Mar 2027; retail pharmacies pay about $0.4536 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0185-0022-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0185 labeler · 0022 product · 01 package
- Package marketed since
- Feb 15, 2000
- Package marketing ended
- Mar 20, 2027
- Sample package
- No — commercial package
- Billing quantity
- 100 EA per package
- Barcode (UPC-A, from the NDC)
- 3 0185002201 4
- Medicaid fills, this package
- 56 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Past resolved recalls for this product (1)
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 004595
- GCN: 17670
- GPI-14 (Medi-Span): 75100080107410
- HICL (First Databank): 001906
- AHFS class code: 12:20.10.00
- RxCUI (RxNorm): 994521
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Muscle Relaxant class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- 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?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.454 | $45.36 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.3776 | $37.76 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.7752 | $77.52 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00185-0022-01 You're viewing this Main listing | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE | $0.4536 / ea | $45.36 | 2000-02-15 | Mar 20, 2027 | Active |
| 00185-0022-10 0185-0022-10 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE | $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 ($0.4536 NADAC).
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00185-0022-10?
What NDC number is used to bill for this package of Orphenadrine Citrate 100 mg Tablet, Extended Release?
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Orphenadrine Citrate 100 mgthis 00185-0022-01 | Sandoz | 100 tablets | $0.454 | AB | Availability likely | — |
| Orphenadrine Citrate 100 mg 43386-0480-24 | Lupin | 100 tablets | $0.454 | 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Orphenadrine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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.
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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?
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Sandoz Inc labeler code 00185
- Metolazone 5 mg Tablet NDC 0185-0055-01
- Nitrofurantoin (monohydrate/macrocrystals) 75 mg; 25 mg Capsule NDC 0185-0122-01
- Bumetanide .5 mg Tablet NDC 0185-0128-01
- Bumetanide 1 mg Tablet NDC 0185-0129-01
- Bumetanide 2 mg Tablet NDC 0185-0130-01
- Benazepril Hydrochloride and Hydrochlorothiazide 20 mg; 12.5 mg Tablet, Film Coated NDC 0185-0211-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
DOSAGE AND ADMINISTRATION Adults-Two tablets per day; one in the morning and one in the evening.
⛔ Contraindications ▾
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 ▾
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 ▾
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 ▾
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 ▾
PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established.
🆘 Overdosage ▾
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 ▾
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 ▾
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
⚠️ Precautions ▾
PRECAUTIONS Confusion, anxiety and tremors have been reported in few patients receiving propoxyphene and orphenadrine concomitantly. As these symptoms may be simply due to an additive effect, reduction of dosage and/or discontinuation of one or both agents is recommended in such cases. Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, cardiac arrhythmias.
Safety of continuous long-term therapy with orphenadrine citrate has not been established. Therefore, if orphenadrine citrate is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.
🔒 Drug Abuse and Dependence ▾
DRUG ABUSE AND DEPENDENCE Orphenadrine citrate has been chronically abused for its euphoric effects. [1] The mood elevating effects may occur at therapeutic doses of orphenadrine. [2]
📄 Package Label / Principal Display Panel ▾
Orphenadrine Citrate Extended-Release Tablets, USP, 100 mg x 100 Tablets - Label NDC 0185-0022-01 Orphenadrine Citrate Extended-Release Tablets, USP 100 mg Rx only 100 Tablets Sandoz Image-02