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Pyridostigmine Bromide 60 mg Tablet, 500-count — NDC 00115-3511-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pyridostigmine Bromide 60 mg Tablet, 500-count — NDC 0115-3511-02 (Billing 00115-3511-02)

by Amneal Pharmaceuticals of New York LLC · 500 TABLET in 1 BOTTLE

This is a package of 500 tablets of Pyridostigmine Bromide 60 mg Tablet from Amneal Pharmaceuticals of New York LLC, marketed since Apr 2003 and currently FDA-listed.

NDC 00115-3511-02
🏷️ FDA NDC (as labeled) 0115-3511-02 billing pads the labeler segment with a zero
This package
Contains500-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.3682/unit — full pricing hub ↓
Product page 00115-3511-01 Also comes in: 100 tablets 0115-3511-01
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 0115-3511-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0115 labeler · 3511 product · 02 package
Package marketed since
Apr 24, 2003
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0301153511017
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0115-3511-02
Product NDC 0115-3511
11-digit billing NDC 00115351102
RxCUI 903857
UNII KVI301NA53
UPC 0301153511017
Application # ANDA040502
SPL Set ID 0f56facf-1f0a-4ba5-876d-757b114dfa45
Established class (EPC) Cholinesterase Inhibitor
Mechanism of action Cholinesterase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2003-04-24
Route ORAL
Dosage form TABLET
Substance PYRIDOSTIGMINE BROMIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 76000050100305
GPI class Pyridostigmine Bromide
GCN Seq No 004764
GCN 18530
HICL code 001990
Ingredient (HICL) Pyridostigmine Bromide
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J1
Therapeutic class — intermediate (HIC2) Cholinergics
HIC3 code J1B
Therapeutic class — specific (HIC3) Cholinesterase Inhibitors
AHFS code 12:04.00.00
AHFS class Parasympathomimetic (Cholinergic Agents)
FDB label name PYRIDOSTIGMINE BR 60 MG TABLET
FDB brand name Pyridostigmine Bromide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004764
  • GCN: 18530
  • GPI-14 (Medi-Span): 76000050100305
  • HICL (First Databank): 001990
  • AHFS class code: 12:04.00.00
  • RxCUI (RxNorm): 903857
Why two NDCs? The FDA registers this code as 0115-3511-02 — a 4-4-2 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 labeler segment → 00115-3511-02. 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 Cholinesterase Inhibitor class.

Pharmacologic class Cholinesterase Inhibitor
Drug family (ATC) Anticholinesterases
How it works Cholinesterase Inhibitors
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 PYRIDOSTIGMINE BR 60 MG TABLET Ingredient Pyridostigmine Bromide
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Mestinon and the oral solution treat myasthenia gravis. Regonol is a hospital injection that reverses muscle relaxants. Other tablets are for military us...
  • Take it exactly as prescribed. Oral products are swallowed, and doses are adjusted to your needs and spaced through the day. The military extended-release tablet must be taken with...
  • Stomach upset is most common, including diarrhea, cramps and nausea. Some people notice twitching, sweating or drooling. These come from extra acetylcholine activity, so tell your...
  • Get help right away for trouble breathing, severe dizziness, fainting, or growing muscle weakness. These can be signs of a serious reaction or too much medicine.
📖 Read our full Pyridostigmine 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 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 $0.3682 $184.10 / 500 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 Per unit Per pack Marketing startMarketing endStatus
00115-3511-01 0115-3511-01 Main listing 100 TABLET in 1 BOTTLE $0.2487 / ea $24.87 2003-04-24 — Active
00115-3511-02 You're viewing this 500 TABLET in 1 BOTTLE — — 2003-04-24 — Active

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

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet in 1 bottle.
How does this package differ from NDC 00115-3511-01?
Both are Pyridostigmine Bromide 60 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 00115-3511-01 is the 100 tablets package.
What NDC number is used to bill for this package of Pyridostigmine Bromide 60 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
Pyridostigmine Bromide 60 mg 68682-0302-10 Oceanside 100 tablets $0.197 AB Discontinued —
pyridostigmine bromide 60 mg 00904-6622-61 Major 100 tablets $0.249 AB Availability likely —
Pyridostigmine Bromide 60 mg 62559-0470-01 ANI 100 tablets $0.249 AB Availability likely —
Pyridostigmine Bromide 60 mg 68084-0494-01 American 100 tablets $0.249 AB Availability likely —
Pyridostigmine Bromide 60 mgthis 00115-3511-02 Amneal 500 tablets — AB FDA listed —
Mestinon 60 mg 00187-3010-30 Bausch 100 tablets — AB FDA listed —
pyridostigmine bromide 60 mg 51407-0590-30 Golden 30 tablets — AB FDA listed —
Pyridostigmine Bromide 60 mg 58657-0811-01 Method 100 tablets — AB FDA listed —
pyridostigmine bromide 60 mg 65841-0819-01 Zydus 100 tablets — AB FDA listed —
pyridostigmine bromide 60 mg 68382-0659-01 Zydus 100 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

🏛️
2003
On the market since
Apr 2003
📍
2026
Currently FDA-listed
23 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
ImprintG3511
Size10 mm
ScoringScored — splits in 4
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.

🧪 Avoiding an ingredient? See Pyridostigmine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

4 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

LabelerAmneal Pharmaceuticals of New York LLC
Application holderIMPAX LABORATORIES INC
FDA applicationANDA040502 (ANDA)
Labeler code00115
First marketedApr 2003
Product typeHuman Prescription Drug
Portfolio228 products on file

More NDCs from Amneal Pharmaceuticals of New York LLC labeler code 00115

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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

INDICATIONS AND USAGE Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis.

⏱️ Dosage and Administration 103 words ▾

DOSAGE AND ADMINISTRATION Pyridostigmine bromide is available in tablets, each containing 60 mg pyridostigmine bromide. Dosage The size and frequency of the dosage must be adjusted to the needs of the individual patient. The average dose is ten 60-mg tablets daily, spaced to provide maximum relief when maximum strength is needed.

In severe cases as many as 25 tablets a day may be required, while in mild cases one to six tablets a day may suffice. Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon ® (edrophonium chloride).

⛔ Contraindications 41 words ▾

CONTRAINDICATIONS Pyridostigmine bromide is contraindicated in mechanical intestinal or urinary obstruction, and particular caution should be used in its administration to patients with bronchial asthma. Care should be observed in the use of atropine for counteracting side effects, as discussed below.

⚠️ Warnings ~1 min read ▾

WARNINGS Although failure of patients to show clinical improvement may reflect underdosage, it can also be indicative of overdosage. As is true of all cholinergic drugs, overdosage of pyridostigmine bromide may result in cholinergic crisis, a state characterized by increasing muscle weakness which, through involvement of the muscles of respiration, may lead to death. Myasthenic crisis due to an increase in the severity of the disease is also accompanied by extreme muscle weakness, and thus may be difficult to distinguish from cholinergic crisis on a symptomatic basis.

Such differentiation is extremely important, since increases in doses of pyridostigmine bromide or other drugs of this class in the presence of cholinergic crisis or of a refractory or “insensitive” state could have grave consequences. Osserman and Genkins 1 indicate that the differential diagnosis of the two types of crisis may require the use of Tensilon ® (edrophonium chloride) as well as clinical judgment. The treatment of the two conditions obviously differs radically.

Whereas the presence of myasthenic crisis suggests the need for more intensive anticholinesterase therapy, the diagnosis of cholinergic crisis, according to Osserman and Genkins, 1 calls for the prompt withdrawal of all drugs of this type. The immediate use of atropine in cholinergic crisis is also recommended. Atropine may also be used to abolish or obtund gastrointestinal side effects or other muscarinic reactions; but such use, by masking signs of overdosage, can lead to inadvertent induction of cholinergic crisis.

For detailed information on the management of patients with myasthenia gravis, the physician is referred to one of the excellent reviews such as those by Osserman and Genkins 2 , Grob 3 or Schwab 4,5 . Usage in Pregnancy The safety of pyridostigmine bromide during pregnancy or lactation in humans has not been established. Therefore, use of pyridostigmine bromide in women who may become pregnant requires weighing the drug’s potential benefits against its possible hazards to mother and child.

🤒 Adverse Reactions 124 words ▾

ADVERSE REACTIONS The side effects of pyridostigmine bromide are most commonly related to overdosage and generally are of two varieties, muscarinic and nicotinic. Among those in the former group are nausea, vomiting, diarrhea, abdominal cramps, increased peristalsis, increased salivation, increased bronchial secretions, miosis and diaphoresis. Nicotinic side effects are comprised chiefly of muscle cramps, fasciculation and weakness.

Muscarinic side effects can usually be counteracted by atropine, but for reasons shown in the preceding section the expedient is not without danger. As with any compound containing the bromide radical, a skin rash may be seen in an occasional patient. Such reactions usually subside promptly upon discontinuance of the medication.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧬 Clinical Pharmacology 57 words ▾

CLINICAL PHARMACOLOGY Pyridostigmine bromide inhibits the destruction of acetylcholine by cholinesterase and thereby permits freer transmission of nerve impulses across the neuromuscular junction. Pyridostigmine is an analog of neostigmine (Prostigmin ® ), but differs from it in certain clinically significant respects; for example, pyridostigmine is characterized by a longer duration of action and fewer gastrointestinal side effects.

📦 How Supplied / Storage and Handling 90 words ▾

HOW SUPPLIED Pyridostigmine Bromide Tablets USP, 60 mg are white to off white, flat-faced, round tablets debossed with "G” and “3511" on one side and double-scored on the other side. They are available as follows: Bottles of 100: NDC 0115-3511-01 Bottles of 500: NDC 0115-3511-02 IMPORTANT: These tablets are hygroscopic. Keep in a dry place with the silica gel enclosed.

Dispense in a tightly-closed, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 53 words ▾

DESCRIPTION Pyridostigmine bromide, USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Pyridostigmine bromide tablets, USP is available as a 60 mg tablet for oral administration. The tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate and stearic acid. MF

⚠️ Precautions 48 words ▾

PRECAUTION Pyridostigmine is mainly excreted unchanged by the kidney 6,7,8 . Therefore, lower doses may be required in patients with renal disease, and treatment should be based on titration of drug dosage to effect 6,7 . Pediatric Use Safety and effectiveness in pediatric patients have not been established.

📚 References 190 words ▾

REFERENCES 1. Osserman KE, Genkins G. Studies in myasthenia gravis: Reduction in mortality rate after crisis.

JAMA. Jan 1963; 183:97-101. 2.

Osserman KE, Genkins G. Studies in myasthenia gravis. NY State J.

Med. June 1961; 61:2076-2085. 3.

Grob D. Myasthenia gravis. A review of pathogenesis and treatment.

Arch Intern Med. Oct 1961; 108:615-638. 4.

Schwab RS. Management of myasthenia gravis. New Eng J Med .

Mar 1963; 268:596-597. 5. Schwab RS.Management of myasthenia gravis.

New Eng J Med . Mar 1963; 268:717-719. 6.

Cronnelly R, Stanski DR, Miller RD, Sheiner LB. Pyridostigmine kinetics with and without renal function. Clin Pharmacol Ther.

1980; 28:No. 1, 78-81. 7.

Miller RD. Pharmacodynamics and pharmacokinetics of anticholinesterase. In: Ruegheimer E, Zindler M, ed.

Anaesthesiology . (Hamburg, Germany: Congress; Sep 14-21, 1980; 222-223.) (Int Congr. No.

538), Amsterdam, Netherlands: Excerpta Medica; 1981. 8. Breyer-Pfaff U, Maier U, Brinkmann AM, Schumm F.

Pyridostigmine kinetics in healthy subjects and patients with myasthenia gravis. Clin Pharmacol Ther . 1985; 5:495-501.

All trademarks are the property of their respective owners. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd.

Ahmedabad 382220, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2024-03

📄 Package Label / Principal Display Panel 10 words ▾

PRINCIPAL DISPLAY PANEL - 60 mg Tablet Bottle Label df

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

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 tablets00115-3511-01 25,965 Rx · $1,031,111
500 tablets this page00115-3511-02 No Medicaid data
Drug total (last 4 qtrs): 25,965 Rx · 3,391,437 units · $1,031,111 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 Pyridostigmine Bromide — the program that covers self-administered drugs. 9 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 Pyridostigmine Bromide. 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
$5.53M
Claims incl. refills
71.4K
Beneficiaries
45.1K
Spend / beneficiary
$122.42
Spend / claim
$77.39
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.

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) ✓ 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.
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 Amneal Pharmaceuticals of New York LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (00115-3511-01). 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?
Amneal Pharmaceuticals of New York 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.
← 00115-2790-02 · Amneal 00115-4411-01 · Amneal →
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.