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Baclofen 10 mg Tablet, 100-count — NDC 59651-0394-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Baclofen 10 mg Tablet, 100-count — NDC 59651-394-01 (Billing 59651-0394-01)

by Aurobindo Pharma Limited · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Baclofen 10 mg Tablet from Aurobindo Pharma Limited, marketed since Jul 2021 and currently FDA-listed; retail pharmacies pay about $0.0320 per tablet (NADAC).

NDC 59651-0394-01
🏷️ FDA NDC (as labeled) 59651-394-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0320 NADAC Per package$3.20 / 100 tablets Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.1604/unit · Part D plans $0.1147/unit — full pricing hub ↓
Product page 59651-0394-99 Also comes in: 500 tablets 59651-394-05 1000 tablets 59651-394-99 5000 tablets 59651-394-59
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

⚠️
Other active recalls for Baclofen (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Nov 26, 2025 — Presence of Foreign Tablets/Capsules (Golden State Medical Supply Inc.) · FDA recall D-0235-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59651-394-01
Product NDC 59651-394
11-digit billing NDC 59651039401
NCPDP billing unit EA — each (per item)
RxCUI 197391, 197392
UNII H789N3FKE8
Application # ANDA214099
SPL Set ID 4679a275-9307-4b0f-a2eb-2d83227ea84d
Established class (EPC) gamma-Aminobutyric Acid-ergic Agonist
Mechanism of action GABA A Agonists; GABA B Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-07-13
Route ORAL
Dosage form TABLET
Substance BACLOFEN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 75100010000305
GPI class Baclofen
GCN Seq No 004679
GCN 18010
HICL code 001949
Ingredient (HICL) Baclofen
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 12:20.12.00
AHFS class Gaba-Derivative Skeletal Muscle Relaxant
FDB label name BACLOFEN 10 MG TABLET
FDB brand name Baclofen
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004679
  • GCN: 18010
  • GPI-14 (Medi-Span): 75100010000305
  • HICL (First Databank): 001949
  • AHFS class code: 12:20.12.00
  • RxCUI (RxNorm): 197391
Why two NDCs? The FDA registers this code as 59651-394-01 — 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 → 59651-0394-01. 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 gamma-Aminobutyric Acid-ergic Agonist class.

Pharmacologic class gamma-Aminobutyric Acid-ergic Agonist
Drug family (ATC) Other centrally acting agents
How it works GABA B Agonists, GABA A Agonists
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.

Clinical

Label name BACLOFEN 10 MG TABLET Ingredient Baclofen
📗 Our plain-language guide HelloPharmacist
  • It eases spasticity, meaning stiff, tight muscles and spasms. Oral forms are used mainly for spasticity from multiple sclerosis and may help with spinal cord injuries. Intrathecal...
  • Oral baclofen is usually started low and split into several doses a day, then increased slowly. Follow your prescriber and label. With liquids, double-check both the mg and mL on y...
  • Don't stop suddenly. Your dose should be lowered slowly. With an intrathecal pump, missing a refill can cause dangerous withdrawal, so keep every appointment.
  • Sleepiness, dizziness, nausea, headache, low blood pressure and muscle weakness are common. Avoid driving until you know how it affects you, and avoid alcohol.
📖 Read our full Baclofen 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.

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 $0.032 $3.20 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1604 $16.04 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1147 $11.47 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jun 2022 Dec 2023 Mar 2026 Sep 2026 $0.066 $0.032
▼ Down 52% over the last 19 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
59651-0394-01 You're viewing this 100 TABLET in 1 BOTTLE $0.0320 / ea $3.20 2021-07-13 — Active
59651-0394-05 59651-394-05 500 TABLET in 1 BOTTLE $0.0320 / ea $16.00 2021-07-13 — Active
59651-0394-99 59651-394-99 Main listing 1000 TABLET in 1 BOTTLE $0.0320 / ea $31.99 2021-07-13 — Active
59651-0394-59 59651-394-59 5000 TABLET in 1 BAG — — — — Active

You're viewing the smallest of 4 pack sizes for this product.

This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.0320 NADAC).

This pack accounts for about 2.3% of this product's recent Medicaid fills; most go to the 1000 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 59651-0394-05?
Both are Baclofen 10 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 59651-0394-05 is the 500 tablets package.
What NDC number is used to bill for this package of Baclofen 10 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Baclofen 10 mg 00172-4096-60 Teva 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 00527-1330-01 Lannett 100 tablets $0.032 — Availability likely —
Baclofen 10 mg 00603-2406-21 Par 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 00832-1054-10 Upsher-Smith 1000 tablets $0.032 AB Availability likely —
Baclofen 10 mg 00904-6475-61 Major 100 tablets $0.032 — Availability likely —
Baclofen 10 mg 00904-7552-61 Major 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 16571-0171-01 Rising 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 16714-0071-04 Northstar 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 29300-0343-01 Unichem 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 50268-0106-15 AvPAK 50 tablets $0.032 AB Availability likely —
Baclofen 10 mg 52817-0320-00 TruPharma 1000 tablets $0.032 AB Availability likely —
Baclofen 10 mg 58657-0731-01 Method 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 58657-0931-01 Method 100 tablets $0.032 AB Availability likely —
Baclofen 10 mgthis 59651-0394-01 Aurobindo 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 60687-0815-01 American 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 62135-0473-05 Chartwell 500 tablets $0.032 AB Availability likely —
Baclofen 10 mg 70512-0782-10 SOLA 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 70710-1285-00 Zydus 1000 tablets $0.032 AB Availability likely —
Baclofen 10 mg 70756-0288-11 Lifestar 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 71930-0006-12 Eywa 100 tablets $0.032 AB Availability likely —
Baclofen 10 mg 72888-0010-00 Advagen 1000 tablets $0.032 AB Availability likely —
Baclofen 10 mg 00615-8466-05 NCS 15 tablets — AB FDA listed —
Baclofen 10 mg 10135-0532-01 Marlex 100 tablets — AB FDA listed —
Baclofen 10 mg 42571-0428-01 Micro 100 tablets — AB Discontinued —
Baclofen 10 mg 43063-0864-30 PD-Rx 30 tablets — — FDA listed —
Baclofen 10 mg 50090-6149-00 A-S 60 tablets — AB FDA listed —
Baclofen 10 mg 50090-6868-00 A-S 60 tablets — AB FDA listed —
Baclofen 10 mg 50090-6869-00 A-S 90 tablets — AB FDA listed —
Baclofen 10 mg 50090-7600-00 A-S 60 tablets — AB FDA listed —
Baclofen 10 mg 50090-7601-00 A-S 90 tablets — AB FDA listed —
Baclofen 10 mg 50090-7913-00 A-S 90 tablets — AB FDA listed —
Baclofen 10 mg 50090-7928-00 A-S 90 tablets — AB FDA listed —
Baclofen 10 mg 51407-0973-01 Golden 100 tablets — AB FDA listed —
Baclofen 10 mg 55154-0198-00 Cardinal 10 tablets — AB FDA listed —
Baclofen 10 mg 55154-7635-00 Cardinal 10 tablets — — FDA listed —
Baclofen 10 mg 55289-0757-30 PD-Rx 30 tablets — AB FDA listed —
Baclofen 10 mg 63187-0147-30 Proficient 30 tablets — AB FDA listed —
Baclofen 10 mg 63187-0313-20 Proficient 20 tablets — AB FDA listed —
Baclofen 10 mg 63629-1224-01 Bryant 1000 tablets — AB FDA listed —
Baclofen 10 mg 63629-1225-01 Bryant 100 tablets — AB FDA listed —
Baclofen 10 mg 63629-2080-01 Bryant 1000 tablets — — FDA listed —
Baclofen 10 mg 63629-2081-01 Bryant 1000 tablets — — FDA listed —
Baclofen 10 mg 63629-2082-01 Bryant 100 tablets — — FDA listed —
Baclofen 10 mg 63629-2128-01 Bryant 100 tablets — AB FDA listed —
Baclofen 10 mg 67046-1072-03 Coupler 30 tablets — AB FDA listed —
Baclofen 10 mg 67296-1947-03 Redpharm 30 tablets — AB FDA listed —
Baclofen 10 mg 67296-2259-03 Redpharm 30 tablets — AB FDA listed —
Baclofen 10 mg 67544-0671-60 Aphena 90 tablets — — FDA listed —
Baclofen 10 mg 68071-2289-03 NuCare 3 tablets — AB FDA listed —
Baclofen 10 mg 68071-3407-03 NuCare 3 tablets — AB FDA listed —
Baclofen 10 mg 68071-3468-06 NuCare 60 tablets — AB Discontinued —
Baclofen 10 mg 68071-3700-03 NuCare 30 tablets — AB FDA listed —
Baclofen 10 mg 68788-8584-01 Preferred 100 tablets — AB FDA listed —
Baclofen 10 mg 68788-8726-01 Preferred 100 tablets — AB FDA listed —
Baclofen 10 mg 68788-8783-01 Preferred 100 tablets — AB FDA listed —
Baclofen 10 mg 68788-9246-01 Preferred 100 tablets — — FDA listed —
Baclofen 10 mg 70518-3089-00 REMEDYREPACK 30 tablets — AB FDA listed —
Baclofen 10 mg 70518-3614-00 REMEDYREPACK 30 tablets — AB Discontinued —
Baclofen 10 mg 70518-4249-00 REMEDYREPACK 30 tablets — AB FDA listed —
Baclofen 10 mg 70518-4384-00 REMEDYREPACK 90 tablets — AB FDA listed —
Baclofen 10 mg 70771-1448-00 Zydus 1000 tablets — AB FDA listed —
Baclofen 10 mg 71205-0474-14 Proficient 14 tablets — — FDA listed —
Baclofen 10 mg 71335-0344-00 Bryant 112 tablets — — Discontinued —
Baclofen 10 mg 71335-1797-00 Bryant 112 tablets — AB FDA listed —
Baclofen 10 mg 71335-2392-00 Bryant 112 tablets — AB FDA listed —
Baclofen 10 mg 71335-2767-00 Bryant 112 tablets — AB FDA listed —
Baclofen 10 mg 71335-2826-01 Bryant 100 tablets — AB FDA listed —
Baclofen 10 mg 71335-9638-00 Bryant 112 tablets — AB FDA listed —
Baclofen 10 mg 71335-9759-00 Bryant 112 tablets — AB FDA listed —
Baclofen 10 mg 71610-0452-60 Aphena 90 tablets — — FDA listed —
Baclofen 10 mg 71610-0660-60 Aphena 90 tablets — AB FDA listed —
Baclofen 10 mg 71610-0924-53 Aphena 60 tablets — AB FDA listed —
Baclofen 10 mg 72162-1079-08 Bryant 140 tablets — — FDA listed —
Baclofen 10 mg 72162-1152-01 Bryant 100 tablets — — FDA listed —
Baclofen 10 mg 72162-2373-00 Bryant 1000 tablets — AB FDA listed —
Baclofen 10 mg 72162-2449-00 Bryant 1000 tablets — AB FDA listed —
Baclofen 10 mg 72789-0479-01 PD-Rx 100 tablets — AB FDA listed —
Baclofen 10 mg 72789-0508-30 PD-Rx 30 tablets — AB FDA listed —
Baclofen 10 mg 72865-0297-01 XLCare 100 tablets — AB FDA listed —
Baclofen 10 mg 76420-0241-30 Asclemed 30 tablets — AB FDA listed —
Baclofen 10 mg 76420-0357-00 Asclemed 1000 tablets — AB FDA listed —
Baclofen 10 mg 80425-0080-02 Advanced 60 tablets — AB FDA listed —
Baclofen 10 mg 80425-0156-01 Advanced 30 tablets — AB FDA listed —
Baclofen 10 mg 80425-0391-01 Advanced 30 tablets — AB FDA listed —
Baclofen 10 mg 80425-0568-01 Advanced 30 tablets — AB FDA listed —
Baclofen 10 mg 82461-0717-10 Medcore 100 tablets — AB FDA listed —
Baclofen 10 mg 82804-0242-20 Proficient 20 tablets — AB FDA listed —
Baclofen 10 mg 82868-0013-30 Northwind 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

🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 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.

What it looks like

Color White
ShapeRound
ImprintB;20
Size11 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 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.
  • UNII X7XJ6RM9Q2
    A plant-derived cellulose processed into tiny crystals. It acts as a binder and filler to give the tablet or capsule structure and helps the medicine break apart properly in your stomach.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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.

Manufacturer & labeler

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA214099 (ANDA)
Labeler code59651
First marketedJul 2021
Product typeHuman Prescription Drug
Portfolio1,456 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.

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 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 109 words ▾

Indications and Usage Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.

⏱️ Dosage and Administration 120 words ▾

DOSAGE AND ADMINISTRATION The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 to 80 mg daily). The following dosage titration schedule is suggested: 5 mg t.i.d. for 3 days 10 mg t.i.d. for 3 days 15 mg t.i.d. for 3 days 20 mg t.i.d. for 3 days Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).

The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal ).

⛔ Contraindications 4 words ▾

CONTRAINDICATIONS Hypersensitivity to baclofen.

⚠️ Warnings ~1 min read ▾

WARNINGS a. Neonatal Withdrawal Symptoms: Withdrawal symptoms have been reported starting hours to days after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure.

If the potential benefit justifies the potential risk to the fetus and oral baclofen is continued during pregnancy, gradually reduce the dose and discontinue baclofen before delivery. If slow withdrawal is not feasible, advise the parents or caregivers of the potential for neonatal withdrawal. b. Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen.

Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued. c. Impaired Renal Function: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage. d. Stroke: Baclofen has not significantly benefited patients with stroke.

These patients have also shown poor tolerability to the drug. e. Pregnancy: Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits.

There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 and 34 times the human daily dose.

There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

🤒 Adverse Reactions 215 words ▾

ADVERSE REACTIONS The most common is transient drowsiness (10% to 63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5% to 15%), weakness (5% to 15%) and fatigue (2% to 4%).

Others reported: Neuropsychiatric: Confusion (1% to 11%), headache (4% to 8%), insomnia (2% to 7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure. Cardiovascular: Hypotension (0% to 9%). Rare instances of dyspnea, palpitation, chest pain, syncope.

Gastrointestinal: Nausea (4% to 12%), constipation (2% to 6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool. Genitourinary: Urinary frequency (2% to 6%); and, rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria. Other: Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion.

Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. The following laboratory tests have been found to be abnormal in a few patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

🧒 Pediatric Use 18 words ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

🆘 Overdosage 58 words ▾

OVERDOSAGE Signs and Symptoms: Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures. Treatment: In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

🧬 Clinical Pharmacology 147 words ▾

Clinical Pharmacology The precise mechanism of action of baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although baclofen is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects.

In studies with animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses.

Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.

📦 How Supplied / Storage and Handling 160 words ▾

HOW SUPPLIED Baclofen Tablets USP, 10 mg are white to off-white, round, flat-faced, beveled-edge scored tablet debossed with “B” above score line and “10” below score line on one side and plain on other side. They are supplied as follows: Bottles of 100 NDC 59651-394-01 Bottles of 500 NDC 59651-394-05 Bottles of 1,000 NDC 59651-394-99 Baclofen Tablets USP, 20 mg are white to off-white, round, flat-faced, beveled-edge scored tablet debossed with “B” above score line and “20” below score line on one side and plain on other side.

They are supplied as follows: Bottles of 100 NDC 59651-395-01 Bottles of 500 NDC 59651-395-05 Bottles of 1,000 NDC 59651-395-99 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Distributed by: Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 032, India Revised: 10/2021

📋 Description 104 words ▾

DESCRIPTION Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides.

Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). FDA approved dissolution test specifications differ from USP.

Chemical Structure

⚠️ Precautions ~1 min read ▾

PRECAUTIONS Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants. Baclofen should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.

In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking baclofen. It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with baclofen. Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug.

Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population. Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

📄 Package Label / Principal Display Panel 64 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (100 Tablet Bottle) NDC 59651-394-01 Rx only Baclofen Tablets, USP 10 mg AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (100 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (100 Tablet Bottle) NDC 59651-395-01 Rx only Baclofen Tablets, USP 20 mg AUROBINDO 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (100 Tablet Bottle)

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

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 this package alone, 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 – Q1 2026 · 5 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
2K
Units reimbursed last 4 qtrs
100.4K
Gross reimbursed last 4 qtrs
$16.1K
Avg / prescription
$8.02
Avg / unit
$0.1604
Latest quarter Q1 2026
340Rx
Medicaid pays / ea
$0.1604
gross reimbursed
vs
NADAC / ea
$0.0320
acquisition cost
=
Spread
+$0.1284
+401% 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 ⓘ
25% FFS 75% MCO
Fee-for-service · 492 Rx Managed care · 1,516 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: 762 units · 13.3 per 100k residents MN Wisconsin: 1,326 units · 22.4 per 100k residents WI Michigan: 1,436 units · 14.3 per 100k residents MI New York: 3,166 units · 16.2 per 100k residents 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: 732 units · 79.7 per 100k residents SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 10,269 units · 87.1 per 100k residents OH Pennsylvania: 5,504 units · 42.5 per 100k residents PA New Jersey: 480 units · 5.2 per 100k residents NJ Massachusetts: no data reported MA California: 9,526 units · 24.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 5,118 units · 82.6 per 100k residents MO Kentucky: 2,965 units · 65.5 per 100k residents KY West Virginia: 8,002 units · 452 per 100k residents WV Virginia: no data reported VA Maryland: 7,858 units · 127 per 100k residents MD Connecticut: 6,992 units · 193 per 100k residents 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: 10,350 units · 95.5 per 100k residents NC South Carolina: 444 units · 8.3 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 2,860 units · 56.0 per 100k residents AL Georgia: 780 units · 7.1 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,290 units · 4.2 per 100k residents TX Florida: 5,541 units · 24.5 per 100k residents FL
Units reimbursed · per 100k residents
4.2452
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 West Virginia 452 /100k
2 Connecticut 193 /100k
3 Maryland 127 /100k
4 North Carolina 95.5 /100k
5 Ohio 87.1 /100k
6 Missouri 82.6 /100k
7 South Dakota 79.7 /100k
8 Kentucky 65.5 /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.
1000 tablets59651-0394-99 81,871 Rx · $985,148
500 tablets59651-0394-05 2,302 Rx · $24,465
100 tablets this page59651-0394-01 2,008 Rx · $16,104
5000 tablets59651-0394-59 No Medicaid data
Drug total (last 4 qtrs): 86,181 Rx · 6,666,469 units · $1,025,717 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 Baclofen — the program that covers self-administered drugs. 23 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 Baclofen. 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
$22.67M
Claims incl. refills
1.3M
Beneficiaries
744.4K
Spend / beneficiary
$30.45
Spend / claim
$17.31
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.
← 59651-0393-01 · Aurobindo 59651-0395-01 · Aurobindo →
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.