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Glycopyrrolate 1 mg Tablet, 100-count — NDC 55111-0648-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Glycopyrrolate 1 mg Tablet, 100-count — NDC 55111-648-01 (Billing 55111-0648-01)

by Dr. Reddy's Laboratories Limited · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Glycopyrrolate 1 mg Tablet from Dr. Reddy's Laboratories Limited, marketed since Jul 2008 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 55111-0648-01
🏷️ FDA NDC (as labeled) 55111-648-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.1993/unit — full pricing hub ↓
Main listing for product 55111-648 · Also comes in: 500 tablets 55111-648-05
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

⚠️
Other active recalls for Glycopyrrolate (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 16, 2026 — Presence of Particulate Matter: Hair was found in product (Fresenius Kabi USA, LLC) · FDA recall D-0725-2026
Class II · Jul 14, 2026 — Failed Impurities/Degradation Specifications (Precision Dose Inc.) · FDA recall D-0741-2026
Class III · Dec 15, 2025 — Failed Impurities/Degradation Specifications (NOVADOZ PHARMACEUTICALS LLC) · FDA recall D-0300-2026
Class II · Dec 16, 2022 — Failed Impurities/Degradation Specifications (Aurolife Pharma, LLC) · FDA recall D-0087-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55111-648-01
Product NDC 55111-648
11-digit billing NDC 55111064801
NCPDP billing unit EA — each (per item)
RxCUI 197738
UNII V92SO9WP2I
Application # ANDA040847
SPL Set ID 725529e8-9c4b-4108-690a-e4f391439736
Established class (EPC) Anticholinergic
Mechanism of action Cholinergic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-07-14
Route ORAL
Dosage form TABLET
Substance GLYCOPYRROLATE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 49102030000310
GPI class Glycopyrrolate
GCN Seq No 004887
GCN 19130
HICL code 002028
Ingredient (HICL) Glycopyrrolate
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J2
Therapeutic class — intermediate (HIC2) Anticholinergics
HIC3 code J2B
Therapeutic class — specific (HIC3) Anticholinergics,Quaternary Ammonium
AHFS code 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name GLYCOPYRROLATE 1 MG TABLET
FDB brand name Glycopyrrolate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 004887
  • GCN: 19130
  • GPI-14 (Medi-Span): 49102030000310
  • HICL (First Databank): 002028
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 197738
Why two NDCs? The FDA registers this code as 55111-648-01 — 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 → 55111-0648-01. 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 Anticholinergic class.

Pharmacologic class Anticholinergic, Cholinergic Muscarinic Antagonist
Drug family (ATC) Antihidrotics
How it works Cholinergic Muscarinic Antagonists, Cholinergic Antagonists
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 GLYCOPYRROLATE 1 MG TABLET Ingredient Glycopyrrolate
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 $0.1993 $19.93 / 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
55111-0648-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2008-07-14 — Active
55111-0648-05 55111-648-05 500 TABLET in 1 BOTTLE 2008-07-14 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 55111-0648-05?
Both are Glycopyrrolate 1 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 55111-0648-05 is the 500 tablets package.
What NDC number is used to bill for this package of Glycopyrrolate 1 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
Glycopyrrolate 1 mg 00904-6709-61 Major 100 tablets $0.100 AA Availability likely —
Glycopyrrolate 1 mg 13107-0014-01 Aurolife 100 tablets $0.100 AA Availability likely —
Glycopyrrolate 1 mg 23155-0606-01 Heritage 100 tablets $0.100 AA Availability likely —
Glycopyrrolate 1 mg 49884-0065-01 Par 100 tablets $0.100 AA Availability likely —
Glycopyrrolate 1 mg 50268-0363-15 AvPAK 50 tablets $0.100 AA Availability likely —
Glycopyrrolate 1 mg 60687-0458-01 American 100 tablets $0.100 AA Availability likely —
Glycopyrrolate 1 mg 62135-0734-60 Chartwell 60 tablets $0.100 AA Availability likely —
Glycopyrrolate 1 mg 69076-0475-01 Quinn 100 tablets $0.100 AA Availability likely —
Glycopyrrolate 1 mg 69315-0139-01 Leading 100 tablets $0.100 AA Availability likely —
Glycopyrrolate 1 mg 70752-0108-10 QUAGEN 100 tablets $0.100 AA Availability likely —
Glycopyrrolate 1 mg 00615-8617-39 NCS 30 tablets — AA FDA listed —
Glycopyrrolate 1 mg 15955-0305-01 Alembic 100 tablets — AA FDA listed —
Glycopyrrolate 1 mg 16571-0743-03 Rising 30 tablets — AA FDA listed —
Glycopyrrolate 1 mgthis 55111-0648-01 Dr. 100 tablets — AA FDA listed —
Glycopyrrolate 1 mg 63629-2206-01 Bryant 100 tablets — AA FDA listed —
Glycopyrrolate 1 mg 63629-7207-01 Bryant 30 tablets — AA FDA listed —
Glycopyrrolate 1 mg 63629-9287-01 Bryant 100 tablets — AA FDA listed —
Glycopyrrolate 1 mg 70518-4597-00 REMEDYREPACK 100 tablets — AA FDA listed —
Glycopyrrolate 1 mg 71335-2075-01 Bryant 30 tablets — AA FDA listed —
Glycopyrrolate 1 mg 71335-3090-01 Bryant 30 tablets — AA FDA listed —
Glycopyrrolate 1 mg 71335-9652-01 Bryant 30 tablets — AA FDA listed —
Glycopyrrolate 1 mg 71921-0110-01 Florida 100 tablets — AA FDA listed —
Glycopyrrolate 1 mg 72162-1477-01 Bryant 100 tablets — AA FDA listed —
Glycopyrrolate 1 mg 72162-2597-01 Bryant 100 tablets — AA FDA listed —
Glycopyrrolate 1 mg 55111-0649-01 Dr. 100 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

🏛️
2008
On the market since
Jul 2008
📍
2026
Currently FDA-listed
18 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
ImprintI;22
Size13 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

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

LabelerDr. Reddy's Laboratories Limited
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA040847 (ANDA)
Labeler code55111
First marketedJul 2008
Product typeHuman Prescription Drug
Portfolio200 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 14 words ▾

INDICATIONS AND USAGE For use as adjunctive therapy in the treatment of peptic ulcer.

⏱️ Dosage and Administration 136 words ▾

DOSAGE AND ADMINISTRATION The dosage of Glycopyrrolate tablets 1 and 2 mg should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The presently recommended maximum daily dosage of Glycopyrrolate is 8 mg. Glycopyrrolate, 1 mg Tablets.

The recommended initial dosage of Glycopyrrolate for adults is one tablet three times daily (in the morning, early afternoon, and at bedtime). Some patients may require two tablets at bedtime to assure overnight control of symptoms. For maintenance, a dosage of one tablet twice a day is frequently adequate.

Glycopyrrolate, 2 mg Tablets . The recommended dosage of Glycopyrrolate for adults is one tablet two or three times daily at equally spaced intervals. Glycopyrrolate tablets are not recommended for use in pediatric patients under the age of 12 years.

⛔ Contraindications 62 words ▾

CONTRAINDICATIONS Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascularstatus in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Glycopyrrolate tablets are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

⚠️ Warnings ~1 min read ▾

WARNINGS In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of Glycopyrrolate tablets. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with this drug would be inappropriate and possibly harmful.

Glycopyrrolate tablets may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery, or performing hazardous work while taking this drug. Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis.

Pregnancy The safety of this drug during pregnancy has not been established. The use of any drug during pregnancy requires that the potential benefits of the drug be weighed against possible hazards to mother and child. Reproduction studies in rats revealed no teratogenic effects from glycopyrrolate; however, the potent anticholinergic action of this agent resulted in diminished rates of conception and of survival at weaning, in a dose-related manner.

Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate. Information on possible adverse effects in the pregnant female is limited to uncontrolled data derived from marketing experience. Such experience has revealed no reports of teratogenic or other fetus-damaging potential.

No controlled studies to establish the safety of the drug in pregnancy have been performed. Nursing Mothers It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

Pediatric Use Since there is no adequate experience in pediatric patients who have received this drug, safety and efficacy in pediatric patients have not been established.

🤒 Adverse Reactions 137 words ▾

ADVERSE REACTIONS Anticholinergics produce certain effects, most of which are extensions of their fundamental pharmacological actions. Adverse reactions to anticholinergics in general may include xerostomia; decreased sweating; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; dilatation of the pupil; cycloplegia; increased ocular tension; loss of taste; headaches; nervousness; mental confusion; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; constipation; bloated feeling; impotence; suppression of lactation; severe allergic reaction or drug idiosyncrasies including anaphylaxis, urticaria and other dermal manifestations.

Glycopyrrolate tablets is chemically a quaternary ammonium compound; hence, its passage across lipid membranes, such as the blood-brain barrier, is limited in contrast to atropine sulfate and scopolamine hydrobromide. For this reason the occurrence of CNS related side effects is lower, in comparison to their incidence following administration of anticholinergics which are chemically tertiary amines that can cross this barrier readily.

🔄 Drug Interactions 8 words ▾

DRUG INTERACTIONS There are no known drug interactions.

🆘 Overdosage 76 words ▾

OVERDOSAGE The symptoms of overdosage of glycopyrrolate are peripheral in nature rather than central. 1. To guard against further absorption of the drug-use gastric lavage, cathartics and/or enemas.

2. To combat peripheral anticholinergic effects (residual mydriasis, dry mouth, etc.)-utilize a quaternary ammonium anticholinesterase, such as neostigmine methylsulfate. 3.

To combat hypotension-use pressor amines (norepinephrine, metaraminol) i.v.; and supportive care. 4. To combat respiratory depression-administer oxygen; utilize a respiratory stimulant such as Dopram ® i.v.; artificial respiration.

🧬 Clinical Pharmacology 133 words ▾

CLINICAL PHARMACOLOGY Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors arepresent in the autonomic effector cells of smooth muscle, cardiac muscle,the sino-atrial node, the atrioventricular node, exocrine glands, and, to alimited degree, in the autonomic ganglia. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal,tracheal, and bronchial secretions.

Glycopyrrolate antagonizes muscarinic symptoms (e.g., bronchorrhea, bronchospasm, bradycardia, and intestinal hypermotility) induced bycholinergic drugs such as the anticholinesterases. The highly polar quaternary ammonium group of glycopyrrolate limits its passage across lipid membranes, such as the blood-brain barrier, in contrastto atropine sulfate and scopolamine hydrobromide, which are non-polartertiary amines which penetrate lipid barriers easily.

📦 How Supplied / Storage and Handling 109 words ▾

HOW SUPPLIED Glycopyrrolate Tablets USP, 1 mg are scored, compressed white tabletsengraved ‘I 21’, and are supplied in bottles of 100’s and 500’s. Bottles of 100 NDC 55111-648-01 Bottles of 500 NDC 55111-648-05. Glycopyrrolate Tablets USP, 2 mg are scored, compressed white tabletsengraved ‘I 22’, and are supplied in bottles of 100’s and 500’s.

Bottles of 100 NDC 55111-649-01 Bottles of 500 NDC 55111-649-05. Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Dispense in tight container.

Manufactured for: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 USA Manufactured by: USV Private Limited, H-13,16,16A,17,18,19,20,21,E-22, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman 396 210, India Revised: 1116

📋 Description 67 words ▾

DESCRIPTION Glycopyrrolate tablets, USP contain the synthetic anticholinergic,glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound withthe following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The structural formula of Glycopyrrolate is represented below: Molecular Formula : C 19 H 28 BrNO 3 Molecular Weight :398.33 Each tablet for oral administration contains 1 mg or 2 mg Glycopyrrolate, USP.

Inactive Ingredients: Dibasic Calcium Phosphate, Lactose Monohydrate, Magnesium Stearate, Povidone and Sodium Starch Glycolate.

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Glycopyrrolate — the program that covers self-administered drugs. 18 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 Glycopyrrolate. 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
$2.44M
Claims incl. refills
67.4K
Beneficiaries
34.1K
Spend / beneficiary
$71.59
Spend / claim
$36.23
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) — 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.
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 Dr. Reddy's Laboratories Limited. 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 500 tablets (55111-0648-05). 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?
Dr. Reddy's Laboratories Limited 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.
← 55111-0646-30 · Dr. 55111-0649-01 · Dr. →
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.