Home › NDC Lookup › Ingredients › Cycloserine › 43598-0235-31
Cycloserine 250 mg Capsule, 30-count — NDC 43598-0235-31 package photo

Cycloserine 250 mg Capsule, 30-count

by Dr. Reddys Laboratories, Inc. · 3 BLISTER PACK in 1 CARTON (43598-235-31) / 10 CAPSULE in 1 BLISTER PACK (43598-235-10)
NDC 43598-0235-31
🏷️ FDA NDC (as labeled) 43598-235-31 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 43598-235-31
Product NDC 43598-235
11-digit billing NDC 43598023531
NCPDP billing unit EA — each (per item)
RxCUI 197551
UNII 95IK5KI84Z
Application # ANDA060593
SPL Set ID 8e7e2665-7a3d-3f54-9f92-5fe845f02ef9
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-15
Route ORAL
Dosage form CAPSULE
Substance CYCLOSERINE
GPI-14 09000030000105
GCN Seq No 009319
GCN 41250
HICL code 004038
Ingredient (HICL) Cycloserine
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1G
Therapeutic class — specific (HIC3) Antitubercular Antibiotics
AHFS code 08:16.04.00
AHFS class Antituberculosis Agents
FDB label name CYCLOSERINE 250 MG CAPSULE
FDB brand name Cycloserine
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 43598-235-31 — 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 → 43598-0235-31. 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 Antibiotics class.

Drug family (ATC) Antibiotics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerDr. Reddys Laboratories, Inc.
Application holderSANALUZ LLC
FDA applicationANDA060593 (ANDA)
Labeler code43598
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio5 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CYCLOSERINE 250 MG CAPSULE Ingredient Cycloserine
8
Nutrient depletion considerations

Cycloserine may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Cycloserine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color red / gray
ShapeCapsule
ImprintPGC;F04
Size2 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 $58.39 $1,751.67 / 30 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cycloserine 250 mgthis 43598-0235-31 Dr. 30 capsules — — 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Cycloserine — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Cycloserine. 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.
Total Part D spend
$28.6K
Claims incl. refills
19
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$1,503.58
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for CYCLOSERINE — the ingredient across all brands.

Top reported reactions

Electrocardiogram Qt Prolonged291
Neuropathy Peripheral235
Anaemia222
Vomiting174
Nausea151
Drug Resistance120
Hepatotoxicity113

Age at onset

Neonate6
Infant8
Child16
Adolescent23
Adult738
Elderly94

Reporter sex

2,275 reports
Male · 57%
Female · 42%
Unknown · 0%

Serious outcomes

Hospitalization792
Life-threatening193
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 164 119
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
43598-0235-31 You're viewing this 3 BLISTER PACK in 1 CARTON (43598-235-31) / 10 CAPSULE in 1 BLISTER PACK (43598-235-10) 2023-03-15 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 43598-235-31, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 43598-0235-31, written without dashes as 43598023531. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 43598-0235-31, the first segment (43598) is the labeler code FDA assigned to Dr. Reddys Laboratories, Inc.; the middle segment (0235) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (31) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Dr. Reddys Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dr. Reddys Laboratories, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 114 words ▾

INDICATIONS AND USAGE Cycloserine is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis drugs, cycloserine should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent. Cycloserine may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram-positive and gram- negative bacteria.

Use of cycloserine in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be susceptible to the drug

⏱️ Dosage and Administration 63 words ▾

DOSAGE AND ADMINISTRATION Cycloserine is effective orally and is currently administered only by this route. The usual dosage is 500 mg to 1 g daily in divided doses monitored by blood levels. 1 The initial adult dosage most frequently given is 250 mg twice daily at 12-hour intervals for the first 2 weeks. A daily dosage of 1 g should not be exceeded.

⛔ Contraindications 33 words ▾

CONTRAINDICATIONS Administration is contraindicated in patients with any of the following: • Hypersensitivity to cycloserine • Epilepsy • Depression, severe anxiety, or psychosis • Severe renal insufficiency • Excessive concurrent use of alcoho

⚠️ Warnings 94 words ▾

WARNINGS Administration of cycloserine should be discontinued or the dosage reduced if the patient develops allergic dermatitis or symptoms of CNS toxicity, such as convulsions, psychosis, somnolence, depression, confusion, hyperreflexia, headache, tremor, vertigo paresis, or dysarthria. The toxicity of cycloserine is closely related to excessive blood levels (above 30 mcg/mL), as determined by high dosage or inadequate renal clearance. The ratio of toxic dose to effective dose in tuberculosis is small.

The risk of convulsions is increased in chronic alcoholics. Patients should be monitored by hematologic, renal excretion, blood level, and liver function studies.

🤒 Adverse Reactions 156 words ▾

ADVERSE REACTIONS Most adverse reactions occurring during therapy with cycloserine involve the nervous system or are manifestations of drug hypersensitivity. The following side effects have been observed in patients receiving cycloserine: Nervous system symptoms (which appear to be related to higher dosages of the drug, i.e., more than 500 mg daily) • Convulsions • Drowsiness and somnolence • Headache • Tremor • Dysarthria • Vertigo • Confusion and disorientation with loss of memory • Psychoses, possibly with suicidal tendencies • Character changes • Hyperirritability • Aggression • Paresis • Hyperreflexia • Paresthesia • Major & minor (localized) clonic seizures • Coma Cardiovascular: Sudden development of congestive heart failure in patients receiving 1 to 1.5 g of cycloserine daily has been reported.

Allergy (apparently not related to dosage) Skin rash Miscellaneous: Elevated serum transaminase, especially in patients with preexisting liver disease To report SUSPECTED ADVERSE REACTIONS, contact Cerovene, Inc. at 1-833-304-9569 or FDA at 1‑800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 122 words ▾

OVERDOSAGE Signs and Symptoms: Acute toxicity from cycloserine can occur if more than 1 g is ingested by an adult. Chronic toxicity from cycloserine is dose related and can occur if more than 500 mg is administered daily. The central nervous system is the most common organ system involved with toxicity.

Toxic effects may include headache, vertigo, confusion, drowsiness, hyperirritability, paresthesias, dysarthria, psychosis paresis, convulsions, and coma. Treatment: In adults, many of the neurotoxic effects of cycloserine can be both treated and prevented with the administration of 200 to 300 mg of pyridoxine daily. Hemodialysis has been shown to remove cycloserine from the bloodstream.

This procedure should be reserved for patients with life threatening toxicity that is unresponsive to less invasive therapy.

🧬 Clinical Pharmacology 190 words ▾

CLINICAL PHARMACOLOGY After oral administration, cycloserine is readily absorbed from the gastrointestinal tract, with peak blood levels occurring in 4 to 8 hours. Blood levels of 25 to 30 mcg/mL can generally be maintained with the usual dosage of 250 mg twice a day, although the relationship of plasma levels to dosage is not always consistent. Concentrations in the cerebrospinal fluid, pleural fluid, fetal blood, and mother’s milk approach those found in the serum.

Detectable amounts are found in ascitic fluid, file, sputum, amniotic fluid, and lung and lymph tissues. Approximately 65% of a single dose of cycloserine can be recovered in the urine within 72 hours after oral administration. The remaining 35% is apparently metabolized to unknown substances.

The maximum excretion rate occurs 2 to 6 hours after administration, with 50% of the drug eliminated in 12 hours. Mechanism of Action: The antibacterial activity of Cycloserine results from inhibition of cell-wall synthesis in susceptible strains of gram-positive and gram-negative bacteria. Antibacterial Activity: Cycloserine has been shown to be active against most isolates of the following microorganism, both in vitro and in clinical infections [see Indications and Usage]: Mycobacterium tuberculosis.

📦 How Supplied / Storage and Handling 83 words ▾

HOW SUPPLIED Cycloserine is available as a 250 mg capsule with an opaque red cap and opaque gray body imprinted with “PGC” and “F04” in edible black ink on both the cap and the body. Cycloserine Capsules, USP are supplied in cartons of 3 cards. Each card is a ten-capsules blister card as follows: NDC 43598-235-31: carton with 3 cards.

NDC 43598-235-10 (ten 250mg capsules per card). Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 135 words ▾

DESCRIPTION D -Cycloserine, (R)-4-amino-3-isoxazolidinone, is a broad-spectrum antibiotic that is produced by a strain of Streptomyces orchidaceus and has also been synthesized. Cycloserine is a white to off-white powder that is soluble in water and stable in alkaline solution. It is rapidly destroyed at a neutral or acid pH.

Cycloserine has a pH between 5.5 and 6.5 in a solution containing 100 mg/mL. The molecular weight of cycloserine is 102.09, and it has an empirical formula of C 3H6N2O 2 . The structural formula of cycloserine is as follows: Each capsule contains cycloserine, 250 mg (2.45 mmol); D & C Yellow No.

10, F D & C Blue No. 1, F D & C Red No. 3, F D & C Yellow No.

6, gelatin, iron oxide, talc, and titanium dioxide. Structural Formula of Cycloserine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 43598-0233-11 · Dr. 43598-0247-30 · Dr.Reddy's →
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.