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Baclofen 5 mg Tablet, 90-count — NDC 62135-0472-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Baclofen 5 mg Tablet, 90-count — NDC 62135-472-90 (Billing 62135-0472-90)

by Chartwell RX, LLC · 90 TABLET in 1 BOTTLE

This is a package of 90 tablets of Baclofen 5 mg Tablet from Chartwell RX, LLC, marketed since Sep 2021 and currently FDA-listed; retail pharmacies pay about $0.0680 per tablet (NADAC). It is this product's only package size.

NDC 62135-0472-90
🏷️ FDA NDC (as labeled) 62135-472-90 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 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) 62135-472-90
Product NDC 62135-472
11-digit billing NDC 62135047290
NCPDP billing unit EA — each (per item)
RxCUI 197391, 197392, 430902
UNII H789N3FKE8
UPC 0362135474904, 0362135472900, 0362135474058, 0362135473051 +1 more
Application # ANDA077241
SPL Set ID 2a75db96-590a-43cf-aefb-3bbcb287dbf0
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 2021-09-22
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 75100010000303
GCN Seq No 027229
GCN 18012
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 5 MG TABLET
FDB brand name Baclofen
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 027229
  • GCN: 18012
  • GPI-14 (Medi-Span): 75100010000303
  • HICL (First Databank): 001949
  • AHFS class code: 12:20.12.00
  • RxCUI (RxNorm): 197391
Why two NDCs? The FDA registers this code as 62135-472-90 — 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 → 62135-0472-90. 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 5 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 $0.068 $6.12 / 90 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 · Q2 2026 $0.1147 $10.32 / 90 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.161 $0.063
▼ Down 57% over the last 13 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 Marketing startMarketing endStatus
62135-0472-90 You're viewing this Main listing 90 TABLET in 1 BOTTLE 2023-03-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Baclofen 5 mg 00527-1333-01 Lannett 100 tablets $0.068 AB Availability likely —
Baclofen 5 mg 00904-7558-06 Major 50 tablets $0.068 AB Availability likely —
Baclofen 5 mg 16571-0169-01 Rising 100 tablets $0.068 AB Availability likely —
Baclofen 5 mg 29300-0474-01 Unichem 100 tablets $0.068 AB Availability likely —
Baclofen 5 mg 50268-0105-15 AvPAK 50 tablets $0.068 AB Availability likely —
Baclofen 5 mg 52817-0319-10 TruPharma 100 tablets $0.068 AB Availability likely —
Baclofen 5 mg 58657-0730-01 Method 100 tablets $0.068 AB Availability likely —
Baclofen 5 mg 58657-0930-01 Method 100 tablets $0.068 AB Availability likely —
Baclofen 5 mg 60687-0804-65 American 50 tablets $0.068 AB Availability likely —
Baclofen 5 mgthis 62135-0472-90 Chartwell 90 tablets $0.068 AB Availability likely —
Baclofen 5 mg 70710-1609-01 Zydus 100 tablets $0.068 AB Availability likely —
Baclofen 5 mg 70756-0085-11 Lifestar 100 tablets $0.068 AB Availability likely —
Baclofen 5 mg 71930-0066-12 Eywa 100 tablets $0.068 AB Availability likely —
Baclofen 5 mg 72888-0009-01 Advagen 100 tablets $0.068 AB Availability likely —
Baclofen 5 mg 00615-8518-05 NCS 15 tablets — AB FDA listed —
Baclofen 5 mg 42571-0427-01 Micro 100 tablets — AB Discontinued —
Baclofen 5 mg 51407-0972-01 Golden 100 tablets — AB FDA listed —
Baclofen 5 mg 55154-4349-00 Cardinal 10 tablets — AB FDA listed —
Baclofen 5 mg 70518-4656-00 REMEDYREPACK 14 tablets — AB FDA listed —
Baclofen 5 mg 70771-1586-01 Zydus 100 tablets — AB FDA listed —
Baclofen 5 mg 71335-3050-01 Bryant 30 tablets — AB FDA listed —
Baclofen 5 mg 71335-3051-01 Bryant 30 tablets — AB FDA listed —
Baclofen 5 mg 72162-2372-01 Bryant 100 tablets — AB FDA listed —
Baclofen 5 mg 72162-2448-01 Bryant 100 tablets — AB FDA listed —
Baclofen 5 mg 72789-0478-01 PD-Rx 100 tablets — AB FDA listed —
Baclofen 5 mg 72865-0296-01 XLCare 100 tablets — AB FDA listed —
Baclofen 5 mg 76420-0356-01 Asclemed 100 tablets — AB FDA listed —
Baclofen 5 mg 82804-0219-90 Proficient 90 tablets — AB FDA listed —
Baclofen 5 mg 84386-0035-93 Aurobindo 9000 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
Sep 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerChartwell RX, LLC
Application holderLANNETT CO INC
FDA applicationANDA077241 (ANDA)
Labeler code62135
First marketedSep 2021
Product typeHuman Prescription Drug
Portfolio521 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 108 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 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 121 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 ~2 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 220 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.

🆘 Overdosage 60 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 167 words ▾

HOW SUPPLIED Baclofen Tablets USP, 5 mg are available as a white round convex tablet debossed with “LCI” on one side and “1333” on the other side. Available in bottles of 90 (NDC 62135-472-90). Baclofen Tablets USP, 10 mg are available as a white round flat-faced beveled edge bisected tablet debossed with "LCI" over "1330" on one side and plain on the other side, containing 10 mg Baclofen USP.

Available in bottles of 90 (NDC 62135-473-90) and 500 (NDC 62135-473-05). Baclofen Tablets USP, 20 mg are available as a white round flat-faced beveled edge bisected tablet debossed with "LCI" over "1337" on one side and plain on the other side, containing 20 mg Baclofen USP. Available in bottles of 90 (NDC 62135-474-90) and 500 (NDC 62135-474-05).

PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured for: Chartwell RX, LLC.

Congers, NY 10920 L71279 Rev. 02/2023

📋 Description 82 words ▾

DESCRIPTION Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is: Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder.

It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. baclofen, usp

⚠️ 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 69 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Baclofen Tablets, USP 5 mg- NDC 62135-472-90 - 90s-bottle label Baclofen Tablets, USP 10 mg- NDC 62135-473-90 - 90s-bottle label Baclofen Tablets, USP 10 mg- NDC 62135-473-05 - 500s-bottle label Baclofen Tablets, USP 20 mg- NDC 62135-474-90 - 90s-bottle label Baclofen Tablets, USP 20 mg- NDC 62135-474-05 - 500s-bottle label Baclofen Tablets USP Baclofen Tablets USP Baclofen Tablets USP Baclofen Tablets USP Baclofen Tablets USP

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

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.
← 62135-0471-18 · Chartwell 62135-0473-05 · Chartwell →
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.