Home › NDC Lookup › Ingredients › Mecamylamine Hydrochloride › 83649-0558-01
⚪image loading
(from DailyMed)

Vecamyl Mecamylamine Hydrochloride 2.5 mg Tablet, 100-count — NDC 83649-558-01 (Billing 83649-0558-01)

by TILDE Sciences LLC · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Vecamyl Mecamylamine Hydrochloride 2.5 mg Tablet from TILDE Sciences LLC, marketed since Mar 2013 and currently FDA-listed. It is this product's only package size.

NDC 83649-0558-01
🏷️ FDA NDC (as labeled) 83649-558-01 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 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83649-558-01
Product NDC 83649-558
11-digit billing NDC 83649055801
NCPDP billing unit EA — each (per item)
RxCUI 1298874, 1373008
UNII 4956DJR58O
UPC 0383649558010
Application # ANDA204054
SPL Set ID 0b149023-f7a8-442d-ac69-295df8e66ed3
Established class (EPC) Autonomic Ganglionic Blocker
Physiologic effect Decreased Autonomic Ganglionic Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-03-19
Route ORAL
Dosage form TABLET
Substance MECAMYLAMINE HYDROCHLORIDE

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

GPI-14 36600020100310
GCN Seq No 000373
GCN 01471
HICL code 000126
Ingredient (HICL) Mecamylamine Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4C
Therapeutic class — specific (HIC3) Antihypertensives, Ganglionic Blockers
AHFS code 24:08.92.00
AHFS class Vasodilating Agents, Misc (24:08)
FDB label name VECAMYL 2.5 MG TABLET
FDB brand name Vecamyl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000373
  • GCN: 01471
  • GPI-14 (Medi-Span): 36600020100310
  • HICL (First Databank): 000126
  • AHFS class code: 24:08.92.00
  • RxCUI (RxNorm): 1298874
Why two NDCs? The FDA registers this code as 83649-558-01 — 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 → 83649-0558-01. 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 Autonomic Ganglionic Blocker class.

Pharmacologic class Autonomic Ganglionic Blocker
Drug family (ATC) Secondary and tertiary amines
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 VECAMYL 2.5 MG TABLET Ingredient Mecamylamine Hcl

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Mecamylamine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Mecamylamine 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 $60.43 $6,042.64 / 100 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
83649-0558-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2025-02-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vecamyl 2.5 mg 69413-0558-40 Vyera 100 tablets — — FDA listed —
Vecamyl 2.5 mgthis 83649-0558-01 TILDE 100 tablets — — 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

🏛️
2013
On the market since
Mar 2013
📍
2026
Currently FDA-listed
13 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

LabelerTILDE Sciences LLC
Application holderLGM PHARMA SOLUTIONS LLC
FDA applicationANDA204054 (ANDA)
Labeler code83649
First marketedMar 2013
Product typeHuman Prescription Drug
Portfolio2 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 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

INDICATIONS AND USAGE For the management of moderately severe to severe essential hypertension and in uncomplicated cases of malignant hypertension.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Therapy is usually started with one 2.5 mg tablet of Mecamylamine HCl twice a day. This initial dosage should be modified by increments of one 2.5 mg tablet at intervals of not less than 2 days until the desired blood pressure response occurs (the criterion being a dosage just under that which causes signs of mild postural hypotension). The average total daily dosage of Mecamylamine HCl is 25 mg, usually in three divided doses.

However, as little as 2.5 mg daily may be sufficient to control hypertension in some patients. A range of two to four or even more doses may be required in severe cases when smooth control is difficult to obtain. In severe or urgent cases, larger increments at smaller intervals may be needed.

Partial tolerance may develop in certain patients, requiring an increase in the daily dosage of Mecamylamine HCl. Administration of Mecamylamine HCl after meals may cause a more gradual absorption and smoother control of excessively high blood pressure. The timing of doses in relation to meals should be consistent.

Since the blood pressure response to antihypertensive drugs is increased in the early morning, the larger dose should be given at noontime and perhaps in the evening. The morning dose, as a rule, should be relatively small and in some instances may even be omitted. The initial regulation of dosage should be determined by blood pressure readings in the erect position at the time of maximal effect of the drug, as well as by other signs and symptoms of orthostatic hypotension.

The effective maintenance dosage should be regulated by blood pressure readings in the erect position and by limitation of dosage to that which causes slight faintness or dizziness in this position. If the patient or a relative can use a sphygmomanometer, instructions may be given to reduce or omit a dose if readings fall below a designated level or if faintness or lightheadedness occurs. However, no change should be instituted without the knowledge of the physician.

Close supervision and education of the patient, as well as critical adjustment of dosage, are essential to successful therapy. Other Antihypertensive Agents When Mecamylamine HCl is given with other antihypertensive drugs, the dosage of these other agents, as well as that of Mecamylamine HCl, should be reduced to avoid excessive hypotension. However, thiazides should be continued in their usual dosage, while that of Mecamylamine HCl is decreased by at least 50 percent.

⛔ Contraindications 82 words ▾

CONTRAINDICATIONS Mecamylamine HCl should not be used in mild, moderate, labile hypertension and may prove unsuitable in uncooperative patients. It is contraindicated in coronary insufficiency or recent myocardial infarction. Mecamylamine HCl should be given with great discretion, if at all, when renal insufficiency is manifested by a rising or elevated BUN.

The drug is contraindicated in uremia. Patients receiving antibiotics and sulfonamides should generally not be treated with ganglion blockers. Other contraindications are glaucoma, organic pyloric stenosis or hypersensitivity to the product.

⚠️ Warnings 124 words ▾

WARNINGS Mecamylamine, a secondary amine, readily penetrates into the brain and thus may produce central nervous system effects. Tremor, choreiform movements, mental aberrations, and convulsions may occur rarely. These have occurred most often when large doses of Mecamylamine HCl were used, especially in patients with cerebral or renal insufficiency.

When ganglion blockers or other potent antihypertensive drugs are discontinued suddenly, hypertensive levels return. In patients with malignant hypertension and others, this may occur abruptly and may cause fatal cerebral vascular accidents or acute congestive heart failure. When Mecamylamine HCl is withdrawn, this should be done gradually and other antihypertensive therapy usually must be substituted.

On the other hand, the effects of Mecamylamine HCl sometimes may last from hours to days after therapy is discontinued.

🤒 Adverse Reactions 80 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported and within each category are listed in order of decreasing severity. Gastrointestinal: Ileus, constipation (sometimes preceded by small, frequent liquid stools), vomiting, nausea, anorexia, glossitis and dryness of mouth. Cardiovascular: Orthostatic dizziness and syncope, postural hypotension.

Nervous System/Psychiatric: Convulsions, choreiform movements, mental aberrations, tremor, and paresthesias (see WARNINGS ). Respiratory: Interstitial pulmonary edema and fibrosis. Urogenital: Urinary retention, impotence, decreased libido.

Special Senses: Blurred vision, dilated pupils. Miscellaneous: Weakness, fatigue, sedation.

🔄 Drug Interactions 30 words ▾

Drug Interactions Patients receiving antibiotics and sulfonamides generally should not be treated with ganglion blockers. The action of Mecamylamine HCl may be potentiated by anesthesia, other antihypertensive drugs and alcohol.

🤰 Pregnancy 49 words ▾

Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Mecamylamine HCl. It is not known whether Mecamylamine HCl can cause fetal harm when given to a pregnant woman or can affect reproductive capacity. Mecamylamine HCl should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 87 words ▾

OVERDOSAGE Signs of overdosage include: hypotension (which may progress to peripheral vascular collapse), postural hypotension, nausea, vomiting, diarrhea, constipation, paralytic ileus, urinary retention, dizziness, anxiety, dry mouth, mydriasis, blurred vision, or palpitations. A rise in intraocular pressure may occur. Pressor amines may be used to counteract excessive hypotension.

Since patients being treated with ganglion blockers are more than normally reactive to pressor amines, small doses of the latter are recommended to avoid excessive response. The oral LD 50 of Mecamylamine HCl in the mouse is 92 mg/kg.

🧬 Clinical Pharmacology 135 words ▾

CLINICAL PHARMACOLOGY Mecamylamine HCl reduces blood pressure in both normotensive and hypertensive individuals. It has a gradual onset of action (1/2 to 2 hours) and a long-lasting effect (usually 6 to 12 hours or more). A small oral dosage often produces a smooth and predictable reduction of blood pressure.

Although this antihypertensive effect is predominantly orthostatic, the supine blood pressure is also significantly reduced. Pharmacokinetics and Metabolism Mecamylamine HCl is almost completely absorbed from the gastrointestinal tract, resulting in consistent lowering of blood pressure in most patients with hypertensive cardiovascular disease. Mecamylamine HCl is excreted slowly in the urine in the unchanged form.

The rate of its renal elimination is influenced markedly by urinary pH. Alkalinization of the urine reduces, and acidification promotes, renal excretion of mecamylamine. Mecamylamine HCl crosses the blood-brain and placental barriers.

📦 How Supplied / Storage and Handling 77 words ▾

HOW SUPPLIED Vecamyl ® (MECAMYLAMINE Hydrochloride Tablets, USP) are slightly yellow, round, compressed tablets, coded MP on one side and 2.5 on the other side. They are supplied as follows: NDC 83649-558-01 in bottles of 100. STORAGE CONDITION Store at 20°C to 25°C (68°F to 77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature.] Dispense in a tight container.

Distributed by: Tilde Sciences, LLC Jersey City, NJ 07302 7183-TL Rev. 06/2024

📋 Description 99 words ▾

DESCRIPTION Mecamylamine HCl is a potent, oral antihypertension agent and ganglion blocker, and is a secondary amine. It is N,2,3,3-tetramethyl-bicyclo [2.2.1] heptan- 2 -amine hydrochloride. Its empirical formula is C 11 H 21 N • HCl and its structural formula is: It is a white, odorless, or practically odorless, crystalline powder, is highly stable, soluble in water and has a molecular weight of 203.75.

Mecamylamine HCl is supplied as tablets for oral use, each containing 2.5 mg mecamylamine HCl. Inactive ingredients are calcium phosphate, D&C Yellow 10, FD&C Yellow 6, lactose, magnesium stearate, cornstarch, and talc. Mecamylamine HCl MF

💬 Information for Patients 42 words ▾

Information for Patients Mecamylamine HCl may cause dizziness, lightheadedness, or fainting, especially when rising from a lying or sitting position. This effect may be increased by alcoholic beverages, exercise, or during hot weather. Getting up slowly may help alleviate such a reaction.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General The patient's condition should be evaluated carefully, particularly as to renal and cardiovascular function. When renal, cerebral, or coronary blood flow is deficient, any additional impairment, which might result from added hypotension, must be avoided. The use of Mecamylamine HCl in patients with marked cerebral and coronary arteriosclerosis or after a recent cerebral accident requires caution.

The action of Mecamylamine HCl may be potentiated by excessive heat, fever, infection, hemorrhage, pregnancy, anesthesia, surgery, vigorous exercise, other antihypertensive drugs, alcohol, and salt depletion as a result of diminished intake or increased excretion due to diarrhea, vomiting, excessive sweating, or diuretics. During therapy with Mecamylamine HCl, sodium intake should not be restricted but, if necessary, the dosage of the ganglion blocker must be adjusted. Since urinary retention may occur in patients on ganglion blockers, caution is required in patients with prostatic hypertrophy, bladder neck obstruction, and urethral stricture.

Frequent loose bowel movements with abdominal distention and decreased borborygmi may be the first signs of paralytic ileus. If these are present, Mecamylamine HCl should be discontinued immediately and remedial steps taken. Information for Patients Mecamylamine HCl may cause dizziness, lightheadedness, or fainting, especially when rising from a lying or sitting position.

This effect may be increased by alcoholic beverages, exercise, or during hot weather. Getting up slowly may help alleviate such a reaction. Drug Interactions Patients receiving antibiotics and sulfonamides generally should not be treated with ganglion blockers.

The action of Mecamylamine HCl may be potentiated by anesthesia, other antihypertensive drugs and alcohol. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of Mecamylamine HCl. Pregnancy Pregnancy Category C.

Animal reproduction studies have not been conducted with Mecamylamine HCl. It is not known whether Mecamylamine HCl can cause fetal harm when given to a pregnant woman or can affect reproductive capacity. Mecamylamine HCl should be given to a pregnant woman only if clearly needed.

Nursing Mothers Because of the potential for serious adverse reactions in nursing infants from Mecamylamine HCl, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🍼 Nursing Mothers 41 words ▾

Nursing Mothers Because of the potential for serious adverse reactions in nursing infants from Mecamylamine HCl, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics 71 words ▾

Pharmacokinetics and Metabolism Mecamylamine HCl is almost completely absorbed from the gastrointestinal tract, resulting in consistent lowering of blood pressure in most patients with hypertensive cardiovascular disease. Mecamylamine HCl is excreted slowly in the urine in the unchanged form. The rate of its renal elimination is influenced markedly by urinary pH.

Alkalinization of the urine reduces, and acidification promotes, renal excretion of mecamylamine. Mecamylamine HCl crosses the blood-brain and placental barriers.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 26 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of Mecamylamine HCl.

📄 Package Label / Principal Display Panel 93 words ▾

Principal Display Panel - Vecamyl Bottle Label TILDE SCIENCES NDC 83649-558-01 vecamyl ® (mecamylamine HCl tablets USP) 2.5 mg Rx only 100 Tablets Each Tablet Contains: Mecamylamine HCI, USP ........................................... 2.5 mg Usual Adult Dosage: Please see package insert for detailed prescribing information. Store and Dispense: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Dispense in tight container.

KEEP OUT OF REACH OF CHILDREN . Distributed by: Tilde Sciences, LLC, Jersey City, NJ 07302 7183-TL Rev 07/2024 Bottle Label

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

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 Mecamylamine Hydrochloride — the ingredient across all brands.

Top reported reactions

Abdominal Distension2
Constipation2
Dizziness2
Fatigue2
Abdominal Pain1
Abnormal Faeces1
Aggression1

Reporter sex

10 reports
Male · 67%
Female · 33%

Serious outcomes

Hospitalization5
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 0
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.

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 — 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 — 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 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.
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 TILDE Sciences LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
TILDE Sciences LLC 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.
← 83649-0330-01 · TILDE 83650-0101-01 · Savvy →
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.