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Baclofen 10 mg Tablet, 100-count — NDC 60687-0815-01 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 60687-815-01 (Billing 60687-0815-01)

by American Health Packaging · 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

This is a package of 100 tablets of Baclofen 10 mg Tablet from American Health Packaging, marketed since May 2024 and currently FDA-listed; retail pharmacies pay about $0.0320 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 60687-0815-01
🏷️ FDA NDC (as labeled) 60687-815-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0320 NADAC Per package$3.20 / 100 tablet Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1740/unit · Part D plans $0.1147/unit — full pricing hub ↓
Main listing for product 60687-815 · Also comes in: 50 tablets 60687-815-65
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

NDC database record

One package, one record: these facts belong to NDC 60687-815-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
60687 labeler · 815 product · 01 package
Package marketed since
May 26, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 6068781501 5
Medicaid fills, this package
59 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
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) 60687-815-01
Product NDC 60687-815
11-digit billing NDC 60687081501
NCPDP billing unit EA — each (per item)
RxCUI 197391, 197392, 430902
UNII H789N3FKE8
Application # ANDA211659
SPL Set ID 8b046ee6-28fc-4ab1-b543-414ad0103e5c
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 2024-05-26
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

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
  • HICL (First Databank): 001949
  • AHFS class code: 12:20.12.00
  • RxCUI (RxNorm): 197391
Why two NDCs? The FDA registers this code as 60687-815-01 — 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 → 60687-0815-01. 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
📖 What it is MedlinePlus · NLM

Baclofen is used to treat pain and certain types of spasticity (muscle stiffness and tightness) from multiple sclerosis, spinal cord injuries, or other spinal cord diseases. Baclofen is in a class of medications called skeletal muscle relaxants. Baclofen acts on the spinal cord nerves and decreases the number and severity of muscle spasms caused by multiple sclerosis or spinal cord conditions. It also relieves pain and improves muscle movement.

Read the full MedlinePlus article ↗
📗 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 tablet
Medicaid paysCMS SDUD · 12 mo $0.1740 $17.40 / 100 tablet
Medicare drug plans payPart D · Q2 2026 $0.1147 $11.47 / 100 tablet
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.036 $0.032
▼ Down 11% over the last 10 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
60687-0815-01 You're viewing this Main listing 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK $0.0320 / ea $3.20 2024-05-26 — Active
60687-0815-65 60687-815-65 50 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK $0.0320 / ea $1.60 2025-08-01 — Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0320 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 blister pack in 1 carton / 1 tablet in 1 blister pack.
How does this package differ from NDC 60687-0815-65?
Both are Baclofen 10 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 60687-0815-65 is the 50 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 mg 59651-0394-01 Aurobindo 100 tablets $0.032 AB Availability likely —
Baclofen 10 mgthis 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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
Imprint1286
Size1 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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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.

6 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

LabelerAmerican Health Packaging
Application holderZYDUS LIFESCIENCES GLOBAL FZE
FDA applicationANDA211659 (ANDA)
Labeler code60687
First marketedMay 2024
Product typeHuman Prescription Drug
Portfolio673 products on file

More NDCs from American Health Packaging labeler code 60687

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 111 words ▾

INDICATIONS AND USAGE Baclofen tablets USP 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 USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen tablets USP 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 131 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 mg to 80 mg daily). The following dosage titration schedule is suggested: 5 mg t.i.d.

(three times in a day) 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. (four times in a day)). 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 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. 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.

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. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

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 ~1 min read ▾

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. To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🆘 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 197 words ▾

HOW SUPPLIED Baclofen Tablets USP, 5 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablets debossed with "16" on one side and "09" on the other side, containing 5 mg baclofen, USP are supplied as follows: Unit dose packages of 50 (5 x 10) NDC 60687-804-65 Baclofen Tablets USP, 10 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with "1285" on one side and break line on the other side, containing 10 mg baclofen, USP are supplied as follows: Unit dose packages of 50 (5 x 10) NDC 60687-815-65 Unit dose packages of 100 (10 x 10) NDC 60687-815-01 Baclofen Tablets USP, 20 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with "1286" on one side and break line on the other side, containing 20 mg baclofen, USP are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 60687-826-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken. Keep this and all drugs out of the reach of children.

📋 Description 98 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: C 10 H 12 ClNO 2 M.W.

213.66 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, 15 mg or 20 mg baclofen, USP.

In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, povidone and sodium starch glycolate. Structural Formula

⚠️ 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 ~2 min read ▾

Package/Label Display Panel – Carton – 5 mg NDC 60687- 804 -65 Baclofen Tablets, USP 5 mg 50 Tablets (5 x 10) Rx Only Each Tablet Contains: Baclofen USP.............................................................................. 5 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 70710-1609, Zydus Pharmaceuticals (USA) Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 780465 0480465/1223 5 mg Baclofen Tablets Carton

Package/Label Display Panel – Blister – 5 mg Baclofen Tablet, USP 5 mg 5 mg Baclofen Tablet Blister

Package/Label Display Panel - Carton - 10 mg NDC 60687- 815 -65 Baclofen Tablets, USP 10 mg 50 Tablets (5 x 10) Rx Only Each Tablet Contains: Baclofen USP............................................................................10 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from NDC # 70710-1285, Zydus Pharmaceuticals (USA) Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 781565 0481565/0525 10 mg Baclofen Tablets Carton 50UD

Package/Label Display Panel – Carton – 10 mg NDC 60687- 815 -01 Baclofen Tablets, USP 10 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Baclofen USP............................................................................10 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from NDC # 70710-1285, Zydus Pharmaceuticals (USA) Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 781501 0481501/1223 10 mg Baclofen Tablets Carton

Package/Label Display Panel – Blister – 10 mg Baclofen Tablet, USP 10 mg 10 mg Baclofen Tablet Blister

Package/Label Display Panel – Carton – 20 mg NDC 60687- 826 -01 Baclofen Tablets, USP 20 mg 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Baclofen USP............................................................................ 20 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 70710-1286, Zydus Pharmaceuticals (USA) Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 782601 0482601/1223 20 mg Baclofen Tablets Carton

Package/Label Display Panel – Blister – 20 mg Baclofen Tablet, USP 20 mg 20 mg Baclofen Tablet Blister

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
59
Units reimbursed last 4 qtrs
2K
Gross reimbursed last 4 qtrs
$356.16
Avg / prescription
$6.04
Avg / unit
$0.1740
Latest quarter Q1 2026
12Rx
Medicaid pays / ea
$0.1740
gross reimbursed
vs
NADAC / ea
$0.0320
acquisition cost
=
Spread
+$0.1420
+444% 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 ⓘ
41% FFS 59% MCO
Fee-for-service · 24 Rx Managed care · 35 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: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,990 units · 10.2 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: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 23 units · 0.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 34 units · 0.8 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported 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: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.110.2
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 New York 10.2 /100k
2 Kentucky 0.8 /100k
3 California 0.1 /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 page60687-0815-01 59 Rx · $356
50 tablets60687-0815-65 No Medicaid data
Drug total (last 4 qtrs): 59 Rx · 2,047 units · $356 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.
← 60687-0814-65 · American 60687-0816-32 · American →
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.