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Hydralazine 25 mg Tablet, 1,000-count — NDC 75834-126-00 (Billing 75834-0126-00)

by Nivagen Pharmaceuticals, Inc. · 1000 TABLET in 1 BOTTLE

This is a package of 1,000 tablets of Hydralazine 25 mg Tablet from Nivagen Pharmaceuticals, Inc., no longer marketed (first marketed Feb 2017), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 75834-0126-00
🏷️ FDA NDC (as labeled) 75834-126-00 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.0607/unit — full pricing hub ↓
Main listing for product 75834-126 · Also comes in: 100 tablets 75834-126-01
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 75834-126-00
Product NDC 75834-126
11-digit billing NDC 75834012600
NCPDP billing unit EA — each (per item)
RxCUI 905222, 905225, 905395
UNII FD171B778Y
UPC 0375834127019, 0375834126012, 0375834128016
Application # ANDA203845
SPL Set ID 1fd8cf42-66ae-4af5-a5ae-7c9679a0e532
Established class (EPC) Arteriolar Vasodilator
Physiologic effect Arteriolar Vasodilation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2017-02-15
Route ORAL
Dosage form TABLET
Substance HYDRALAZINE HYDROCHLORIDE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 36400010100310
GPI class hydrALAZINE HCl
GCN Seq No 000286
GCN 01243
HICL code 000089
Ingredient (HICL) Hydralazine Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4A
Therapeutic class — specific (HIC3) Antihypertensives, Vasodilators
AHFS code 24:08.16.00
AHFS class Direct Vasodilators
FDB label name HYDRALAZINE 25 MG TABLET
FDB brand name Hydralazine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000286
  • GCN: 01243
  • GPI-14 (Medi-Span): 36400010100310
  • HICL (First Databank): 000089
  • AHFS class code: 24:08.16.00
  • RxCUI (RxNorm): 905222
Why two NDCs? The FDA registers this code as 75834-126-00 — 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 → 75834-0126-00. 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 Arteriolar Vasodilator class.

Pharmacologic class Arteriolar Vasodilator
Drug family (ATC) Hydrazinophthalazine derivatives
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 HYDRALAZINE 25 MG TABLET Ingredient Hydralazine Hcl
📗 Our plain-language guide HelloPharmacist
  • Hydralazine is a blood pressure–lowering medication. It works by relaxing the walls of your arteries so blood can flow through more easily, which brings your blood pressure down. K...
  • What exactly is hydralazine supposed to do for me?
  • Your prescription label and your doctor's instructions are the best guide for your specific regimen. Tablets are generally taken several times a day, and your doctor will have star...
  • How do I take my hydralazine tablets — do they need to be taken with food?
📖 Read our full Hydralazine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
2
Nutrient depletion considerations

Hydralazine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Hydralazine 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.

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 $0.0607 $60.70 / 1000 tablets
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
75834-0126-00 You're viewing this Main listing 1000 TABLET in 1 BOTTLE 2017-02-15 — Discontinued by firm
75834-0126-01 75834-126-01 100 TABLET in 1 BOTTLE 2017-02-15 — Discontinued by firm

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 tablet in 1 bottle.
How does this package differ from NDC 75834-0126-01?
Both are Hydralazine 25 mg Tablet — the drug itself is identical. This page's package is the 1,000-count one, while NDC 75834-0126-01 is the 100 tablets package.
What NDC number is used to bill for this package of Hydralazine 25 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydralazine Hydrochloride 25 mg 00904-7448-61 Major 100 tablets $0.036 AA Availability likely —
Hydralazine Hydrochloride 25 mg 23155-0002-01 Heritage 100 tablets $0.036 — Discontinued —
Hydralazine Hydrochloride 25 mg 23155-0833-01 Heritage 100 tablets $0.036 AA Availability likely —
Hydralazine Hydrochloride 25 mg 31722-0520-01 Camber 100 tablets $0.036 AA Availability likely —
Hydralazine Hydrochloride 25 mg 50111-0327-01 Teva 100 tablets $0.036 AA Availability likely —
Hydralazine Hydrochloride 25 mg 50228-0183-01 ScieGen 100 tablets $0.036 AA Availability likely —
Hydralazine Hydrochloride 25 mg 51079-0075-20 Mylan 100 tablets $0.036 AA Availability likely —
Hydralazine Hydrochloride 25 mg 60687-0822-01 American 100 tablets $0.036 AA Availability likely —
Hydralazine Hydrochloride 25 mg 62135-0580-12 Chartwell 120 tablets $0.036 — Availability likely —
HydrALAZINE Hydrochloride 25 mg 64380-0734-06 Strides 100 tablets $0.036 — Availability likely —
HydrALAZINE Hydrochloride 25 mg 76282-0310-01 Exelan 100 tablets $0.036 — Availability likely —
Hydralazine Hydrochloride 25 mg 33342-0375-11 Macleods 100 tablets — — FDA listed —
Hydralazine Hydrochloride 25 mg 48433-0047-20 Safecor 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 50090-0137-00 A-S 100 tablets — AA Discontinued —
Hydralazine Hydrochloride 25 mg 51655-0305-26 Northwind 90 tablets — — Discontinued —
Hydralazine Hydrochloride 25 mg 55154-0186-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 55154-2141-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 55154-5689-00 Cardinal 10 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 55289-0133-60 PD-Rx 60 tablets — — Discontinued —
Hydralazine Hydrochloride 25 mg 63187-0901-30 Proficient 30 tablets — — FDA listed —
Hydralazine Hydrochloride 25 mg 63629-5696-01 Bryant 30 tablets — — Discontinued —
Hydralazine Hydrochloride 25 mg 63629-8496-01 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 63629-8757-01 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 67046-1660-03 Coupler 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 67544-0657-60 Aphena 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 67877-0292-01 Ascend 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 68462-0342-01 Glenmark 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 70518-2551-00 REMEDYREPACK 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 70518-3852-00 REMEDYREPACK 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 70518-4064-02 REMEDYREPACK 180 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 71209-0016-05 Cadila 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 71335-0202-01 Bryant 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 71335-2352-01 Bryant 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 71610-0561-60 Aphena 90 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 72162-1521-00 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 72162-1536-00 Bryant 1000 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 72241-0004-05 Modavar 100 tablets — AA FDA listed —
Hydralazine 25 mgthis 75834-0126-00 Nivagen 1000 tablets — AA Discontinued —
Hydralazine Hydrochloride 25 mg 77771-0183-01 Radha 100 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 82804-0081-30 Proficient 30 tablets — AA FDA listed —
Hydralazine Hydrochloride 25 mg 82868-0045-30 Northwind 30 tablets — AA 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

🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 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

LabelerNivagen Pharmaceuticals, Inc.
Application holderCADILA PHARMACEUTICALS LTD
FDA applicationANDA203845 (ANDA)
Labeler code75834
First marketedFeb 2017
Product typeHuman Prescription Drug
Portfolio95 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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 10 words ▾

INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.

⏱️ Dosage and Administration 150 words ▾

DOSAGE AND ADMINISTRATION Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily.

For maintenance, adjust dosage to the lowest effective levels. The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydrALAZINE hydrochloride tablets. In a few resistant patients, up to 300 mg of hydrALAZINE hydrochloride tablets daily may be required for a significant antihypertensive effect.

In such cases, a lower dosage of hydrALAZINE combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.

⛔ Contraindications 12 words ▾

CONTRAINDICATIONS Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.

⚠️ Warnings 65 words ▾

WARNINGS In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later.

Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests .)

🤒 Adverse Reactions 133 words ▾

ADVERSE REACTIONS Adverse reactions with hydrALAZINE are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency.

Common headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. Less Frequent Digestive constipation, paralytic ileus. Cardiovascular hypotension, paradoxical pressor response, edema.

Respiratory dyspnea. Neurologic peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. Genitourinary difficulty in urination.

Hematologic blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. Hypersensitive Reactions rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. Other nasal congestion, flushing, lacrimation, conjunctivitis.

🔄 Drug Interactions 56 words ▾

Drug/Drug Interactions MAO inhibitors should be used with caution in patients receiving hydrALAZINE. When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydrALAZINE, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydrALAZINE are used concomitantly.

🤰 Pregnancy 108 words ▾

Pregnancy Teratogenic Effect Pregnancy Category C Animal studies indicate that hydrALAZINE is teratogenic in mice at 20 to 30 times the maximum daily human dose of 200 to 300 mg and possibly in rabbits at 10 to 15 times the maximum daily human dose, but that it is nonteratogenic in rats. Teratogenic effects observed were cleft palate and malformations of facial and cranial bones. There are no adequate and well-controlled studies in pregnant women.

Although clinical experience does not include any positive evidence of adverse effects on the human fetus, hydrALAZINE should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 67 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established in controlled clinical trials, although there is experience with the use of hydrALAZINE in pediatric patients. The usual recommended oral starting dosage is 0.75 mg/kg of body weight daily in four divided doses. Dosage may be increased gradually over the next 3 to 4 weeks to a maximum of 7.5 mg/kg or 200 mg daily.

🆘 Overdosage 189 words ▾

OVERDOSAGE Acute Toxicity No deaths due to acute poisoning have been reported. Highest known dose survived: adults, 10 g orally. Oral LD 50 in rats: 173 and 187 mg/kg.

Signs and Symptoms Signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing. Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock. Treatment There is no specific antidote.

The gastric contents should be evacuated, taking adequate precautions against aspiration and for protection of the airway. An activated charcoal slurry may be instilled if conditions permit. These manipulations may have to be omitted or carried out after cardiovascular status has been stabilized, since they might precipitate cardiac arrhythmias or increase the depth of shock.

Support of the cardiovascular system is of primary importance. Shock should be treated with plasma expanders. If possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia.

Tachycardia responds to beta blockers. Digitalization may be necessary, and renal function should be monitored and supported as required. No experience has been reported with extracorporeal or peritoneal dialysis.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Although the precise mechanism of action of hydrALAZINE is not fully understood, the major effects are on the cardiovascular system. HydrALAZINE apparently lowers blood pressure by exerting a peripheral vasodilating effect through a direct relaxation of vascular smooth muscle. HydrALAZINE, by altering cellular calcium metabolism, interferes with the calcium movements within the vascular smooth muscle that are responsible for initiating or maintaining the contractile state.

The peripheral vasodilating effect of hydrALAZINE results in decreased arterial blood pressure (diastolic more than systolic); decreased peripheral vascular resistance; and an increased heart rate, stroke volume, and cardiac output. The preferential dilatation of arterioles, as compared to veins, minimizes postural hypotension and promotes the increase in cardiac output. HydrALAZINE usually increases renin activity in plasma, presumably as a result of increased secretion of renin by the renal juxtaglomerular cells in response to reflex sympathetic discharge.

This increase in renin activity leads to the production of angiotensin II, which then causes stimulation of aldosterone and consequent sodium reabsorption. HydrALAZINE also maintains or increases renal and cerebral blood flow. HydrALAZINE is rapidly absorbed after oral administration, and peak plasma levels are reached at 1 to 2 hours.

Plasma levels of apparent hydrALAZINE decline with a half-life of 3 to 7 hours. Binding to human plasma protein is 87%. Plasma levels of hydrALAZINE vary widely among individuals.

HydrALAZINE is subject to polymorphic acetylation; slow acetylators generally have higher plasma levels of hydrALAZINE and require lower doses to maintain control of blood pressure. HydrALAZINE undergoes extensive hepatic metabolism; it is excreted mainly in the form of metabolites in the urine.

📦 How Supplied / Storage and Handling 126 words ▾

HOW SUPPLIED HydrALAZINE Hydrochloride Tablets USP are available as: 25 mg orange, round, uncoated, biconvex tablet debossed 'C43' on one side and plain on other side Bottles of 100 NDC 75834-126-01 Bottles of 1,000 NDC 75834-126-00 50 mg orange, round, uncoated, biconvex tablet debossed 'C45' on one side and plain on other side Bottles of 100 NDC 75834-127-01 Bottles of 1,000 NDC 75834-127-00 100 mg orange, round, uncoated, biconvex tablet debossed 'C47' on one side and plain on other side Bottles of 100 NDC 75834-128-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required) KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

📦 Storage and Handling 41 words ▾

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required) KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

📋 Description 96 words ▾

DESCRIPTION HydrALAZINE hydrochloride USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: C 8 H 8 N 4 .HCL. M.W.

196.64 HydrALAZINE hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition.

Each tablet for oral administration contains 25 mg, 50 mg or 100 mg HydrALAZINE hydrochloride USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow #6. Chemical Structure

💬 Information for Patients 22 words ▾

Information for Patients Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.

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

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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 ✓ Available
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (75834-0126-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Nivagen Pharmaceuticals, 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.
← 75834-0124-01 · Nivagen 75834-0127-00 · Nivagen →
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.