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ORPHENADRINE CITRATE 100 mg Tablet, Extended Release, 100-count — NDC 43386-0480-24 package photo

ORPHENADRINE CITRATE 100 mg Tablet, Extended Release, 100-count

by Lupin Pharmaceuticals, Inc. · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-24)
NDC 43386-0480-24
🏷️ FDA NDC (as labeled) 43386-480-24 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.4586 NADAC Per package$45.86 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.5632/unit · Part D plans $0.7752/unit — full pricing hub ↓
Also comes in: 500 tablets 43386-0480-26 1000 tablets 43386-0480-28
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) 43386-480-24
Product NDC 43386-480
11-digit billing NDC 43386048024
NCPDP billing unit EA — each (per item)
RxCUI 994521
UNII X0A40N8I4S
Application # ANDA040284
SPL Set ID 7b76c8a7-dd0c-481c-8299-26dfd38ce066
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 1998-06-19
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 43386-480-24 — 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 → 43386-0480-24. 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

LabelerLupin Pharmaceuticals, Inc.
Application holderLUPIN INC
FDA applicationANDA040284 (ANDA)
Labeler code43386
First marketedJun 1998
Product typeHuman Prescription Drug
Portfolio404 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 →

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
ImprintNL4
Size1 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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.
  • 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.

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 $0.459 $45.86 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.5632 $56.32 / 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 mg 00185-0022-01 Sandoz 100 tablets $0.459 AB Availability likely —
Orphenadrine Citrate 100 mgthis 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

🏛️
1998
On the market since
Jun 1998
📍
2026
Currently FDA-listed
28 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 43386-0480-24, 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
63.9K
Units reimbursed last 4 qtrs
2.2M
Gross reimbursed last 4 qtrs
$1.24M
Avg / prescription
$19.35
Avg / unit
$0.5632
Latest quarter Q4 2025
14.5KRx
Medicaid pays / ea
$0.5632
gross reimbursed
vs
NADAC / ea
$0.4586
acquisition cost
=
Spread
+$0.1046
+23% 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 ⓘ
19% FFS 81% MCO
Fee-for-service · 11,989 Rx Managed care · 51,955 Rx
State Medicaid map
Alaska: 3,721 units · 508 per 100k residents AK Maine: no data reported ME Washington: 8,052 units · 103 per 100k residents WA Idaho: 6,671 units · 340 per 100k residents ID Montana: 16,317 units · 1,441 per 100k residents MT North Dakota: 27,812 units · 3,552 per 100k residents ND Minnesota: 53,809 units · 938 per 100k residents MN Wisconsin: 3,505 units · 59.3 per 100k residents WI Michigan: 381,424 units · 3,800 per 100k residents MI New York: 49,154 units · 251 per 100k residents NY Vermont: 3,089 units · 477 per 100k residents VT New Hampshire: 20,539 units · 1,465 per 100k residents NH Oregon: 6,385 units · 151 per 100k residents OR Nevada: 14,360 units · 450 per 100k residents NV Wyoming: no data reported WY South Dakota: 4,780 units · 520 per 100k residents SD Iowa: 68,925 units · 2,149 per 100k residents IA Illinois: 329,693 units · 2,627 per 100k residents IL Indiana: 222,316 units · 3,240 per 100k residents IN Ohio: 179,630 units · 1,524 per 100k residents OH Pennsylvania: 9,793 units · 75.6 per 100k residents PA New Jersey: 16,587 units · 179 per 100k residents NJ Massachusetts: 43,737 units · 625 per 100k residents MA California: 17,618 units · 45.2 per 100k residents CA Utah: 14,702 units · 430 per 100k residents UT Colorado: 10,895 units · 185 per 100k residents CO Nebraska: 4,427 units · 224 per 100k residents NE Missouri: 78,844 units · 1,272 per 100k residents MO Kentucky: 96,092 units · 2,123 per 100k residents KY West Virginia: no data reported WV Virginia: 34,343 units · 394 per 100k residents VA Maryland: 16,133 units · 261 per 100k residents MD Connecticut: 5,529 units · 153 per 100k residents CT Rhode Island: no data reported RI Arizona: 23,439 units · 315 per 100k residents AZ New Mexico: 25,072 units · 1,186 per 100k residents NM Kansas: 7,989 units · 272 per 100k residents KS Arkansas: no data reported AR Tennessee: 16,859 units · 237 per 100k residents TN North Carolina: 20,723 units · 191 per 100k residents NC South Carolina: 16,826 units · 313 per 100k residents SC Delaware: no data reported DE Oklahoma: 139,879 units · 3,451 per 100k residents OK Louisiana: 19,494 units · 426 per 100k residents LA Mississippi: 460 units · 15.6 per 100k residents MS Alabama: 11,079 units · 217 per 100k residents AL Georgia: 25,711 units · 233 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 25,060 units · 82.2 per 100k residents TX Florida: 115,485 units · 511 per 100k residents FL
Units reimbursed · per 100k residents
15.63,800
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 Michigan 3,800 /100k
2 North Dakota 3,552 /100k
3 Oklahoma 3,451 /100k
4 Indiana 3,240 /100k
5 Illinois 2,627 /100k
6 Iowa 2,149 /100k
7 Kentucky 2,123 /100k
8 Ohio 1,524 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page43386-0480-24 63,944 Rx · $1,237,359
500 tablets43386-0480-26 2,658 Rx · $54,851
1000 tablets43386-0480-28 No Medicaid data
Drug total (last 4 qtrs): 66,602 Rx · 2,303,509 units · $1,292,210 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
43386-0480-24 You're viewing this 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-24) $0.4586 / ea $45.86 1998-06-19 Active
43386-0480-26 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-26) $0.4586 / ea $229.31 1998-06-19 Active
43386-0480-28 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-28) — — 1998-06-19 Active

You're viewing the smallest of 3 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.4586 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 96% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 43386-0480-24?
NDC 43386-0480-24 is a 100-count package — 100 tablet, extended release in 1 bottle.
What is the difference between NDC 43386-0480-24 and NDC 43386-0480-26?
Both are ORPHENADRINE CITRATE 100 mg Tablet, Extended Release — the drug itself is identical. NDC 43386-0480-24 is the 100-count package, while NDC 43386-0480-26 is the 500 tablets package.
What NDC number is used to bill for this package of ORPHENADRINE CITRATE 100 mg Tablet, Extended Release?
Bill NDC 43386-0480-24 — the 11-digit billing format is 43386048024. 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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 30 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 musculoskeletal conditions.

⏱️ Dosage and Administration 17 words ▾

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

⛔ Contraindications 47 words ▾

CONTRAINDICATIONS Orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis. Orphenadrine citrate tablets are contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

⚠️ Warnings 42 words ▾

WARNINGS Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine 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 124 words ▾

ADVERSE REACTIONS Adverse reactions of orphenadrine are mainly due to the mild anticholinergic action of orphenadrine, 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.

🤰 Pregnancy 47 words ▾

Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with orphenadrine. It is also not known whether orphenadrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine 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 66 words ▾

OVERDOSAGE Orphenadrine is toxic when overdosed and typically induces anticholinergic effects. 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. Treatment for orphenadrine overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring, and appropriate supportive treatment of any emergent anticholinergic effects.

🧬 Clinical Pharmacology 36 words ▾

CLINICAL PHARMACOLOGY The mode of therapeutic action has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense muscles in man. Orphenadrine citrate also possesses anti-cholinergic actions.

📦 How Supplied / Storage and Handling 98 words ▾

HOW SUPPLIED Orphenadrine citrate extended-release tablets 100 mg are round, white to off-white tablets, debossed NL4 on one side and plain on the other side and are supplied as: NDC 43386-480-24 in bottles of 100 tablets NDC 43386-480-26 in bottles of 500 tablets NDC 43386-480-28 in bottles of 1000 tablets Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc.

Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured For Lupin Pharmaceuticals, Inc. Naples FL, 34108 SAP Code: 276510 Rev: 10/2024 lupin symbol

📋 Description 99 words ▾

DESCRIPTION Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.

The chemical name of orphenadrine citrate is (±) -N,N -Dimethyl-2-[( o -methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C 18 H 23 NO•C 6 H 8 O 7 and molecular weight of 461.51. It has the following structural formula: Each tablet for oral administration contains 100 mg orphenadrine citrate. Each Orphenadrine citrate extended- release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate.

Image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 43386-0450-11 · Lupin 43386-0490-01 · Lupin →
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.