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Orphenadrine Citrate 100 mg Tablet, Extended Release, 1,000-count — NDC 00185-0022-10 package photo

Orphenadrine Citrate 100 mg Tablet, Extended Release, 1,000-count

by Sandoz Inc · 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0022-10)
NDC 00185-0022-10
🏷️ FDA NDC (as labeled) 0185-0022-10 billing pads the labeler segment with a zero
This package
Contains1,000-count Cost per ea$0.5364 NADAC Per package$536.40 / 1000 tablets Pack sizes2 compare ↓
Also comes in: 100 tablets 00185-0022-01
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

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
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0185-0022-10
Product NDC 0185-0022
11-digit billing NDC 00185002210
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 Discontinued
FDA listing status Discontinued by firm
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 0185-0022-10 — 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 → 00185-0022-10. 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 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
📗 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 →

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
ImprintE;22
Size9 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 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 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 $0.536 $536.40 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Mar 2022 Jul 2022 Nov 2022 $0.536 $0.288
▲ Up 86% over the last 12 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 mg 43386-0480-24 Lupin 100 tablets $0.459 AB Availability likely save 15%
Orphenadrine Citrate 100 mgthis 00185-0022-10 Sandoz 1000 tablets $0.536 AB Discontinued —
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 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 tablets00185-0022-01 37 Rx · $739
1000 tablets this page00185-0022-10 No Medicaid data
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
00185-0022-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0022-01) $0.4586 / ea $45.86 2000-02-15 Active
00185-0022-10 You're viewing this 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 largest of 2 pack sizes for this product.

Per ea, this pack runs about 17% above the cheapest pack (100-count, $0.4586 vs $0.5364 NADAC).

Pack size FAQ

What quantity is in NDC 00185-0022-10?
NDC 00185-0022-10 is a 1,000-count package — 1000 tablet, extended release in 1 bottle.
What is the difference between NDC 00185-0022-10 and NDC 00185-0022-01?
Both are Orphenadrine Citrate 100 mg Tablet, Extended Release — the drug itself is identical. NDC 00185-0022-10 is the 1,000-count package, while NDC 00185-0022-01 is the 100 tablets package. Per-ea NADAC also differs: $0.5364 here vs $0.4586 for the 100 tablets pack.
What NDC number is used to bill for this package of Orphenadrine Citrate 100 mg Tablet, Extended Release?
Bill NDC 00185-0022-10 — the 11-digit billing format is 00185002210. 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.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0185-0022-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00185-0022-10, written without dashes as 00185002210. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00185-0022-10, the first segment (00185) is the labeler code FDA assigned to Sandoz Inc; the middle segment (0022) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (00185-0022-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sandoz Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 📦 How Supplied / Storage and Handling 📋 Description
🎯 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 ↗
← 00178-8500-20 · Mission 00185-0055-01 · Sandoz →
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.