HomeNDC LookupIngredientsGlycopyrrolate › 59651-0737-81
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GLYCOPYRROLATE 1 mg Tablet, 8,000-count

by Aurobindo Pharma Limited · 8000 TABLET in 1 BAG (59651-737-81)
NDC 59651-0737-81
🏷️ FDA NDC (as labeled) 59651-737-81 billing pads the product segment with a zero
On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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

FDA NDC (as labeled) 59651-737-81
Product NDC 59651-737
11-digit billing NDC 59651073781
SPL Set ID 7eb8a829-1192-4c9c-a8e2-62f0b2cbcd43
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-28
Dosage form TABLET
Substance GLYCOPYRROLATE
Why two NDCs? The FDA registers this code as 59651-737-81 — 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 → 59651-0737-81. 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.

🏭 Manufacturer & labeler

LabelerAurobindo Pharma Limited
Labeler code59651
First marketedFeb 2023
Product typeDrug For Further Processing
Portfolio1,449 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is a tablet containing 1 mg of glycopyrrolate, an anticholinergic medication. Glycopyrrolate is typically used to reduce saliva and other secretions before surgery or certain medical procedures, and it also functions to relax muscles and reduce spasms in the digestive tract. This listing is classified as a drug for further processing, meaning it is a bulk or intermediate product intended for use in manufacturing or compounding rather than direct patient use.

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.

🧪 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.

💲 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glycopyrrolate 1 mg 23155-0606-01 Heritage 100 tablets $0.099 AA Availability likely
Glycopyrrolate 1 mg 69076-0475-01 Quinn 100 tablets $0.099 AA Availability likely
Glycopyrrolate 1 mg 70752-0108-10 QUAGEN 100 tablets $0.099 AA Availability likely
Glycopyrrolate 1 mg 60687-0458-01 American 100 tablets $0.099 AA Availability likely
Glycopyrrolate 1 mg 69315-0139-01 Leading 100 tablets $0.099 AA Availability likely
Glycopyrrolate 1 mg 00904-6709-61 Major 100 tablets $0.099 AA Availability likely
Glycopyrrolate 1 mg 13107-0014-01 Aurolife 100 tablets $0.099 AA Availability likely
Glycopyrrolate 1 mg 49884-0065-01 Par 100 tablets $0.099 AA Availability likely
Glycopyrrolate 1 mg 50268-0363-15 AvPAK 50 tablets $0.099 AA Availability likely
Glycopyrrolate 1 mg 62135-0734-60 Chartwell 60 tablets $0.099 AA Availability likely
Glycopyrrolate 1 mg 15955-0305-01 Alembic 100 tablets AA FDA listed
Glycopyrrolate 1 mg 55111-0648-01 Dr. 100 tablets AA FDA listed
Glycopyrrolate 1 mg 55111-0649-01 Dr. 100 tablets AA FDA listed
Glycopyrrolate 1 mg 00615-8617-39 NCS 30 tablets AA FDA listed
Glycopyrrolate 1 mg 63629-2206-01 Bryant 100 tablets AA FDA listed
Glycopyrrolate 1 mg 63629-9287-01 Bryant 100 tablets AA FDA listed
Glycopyrrolate 1 mg 16571-0743-03 Rising 30 tablets AA FDA listed
Glycopyrrolate 1 mg 71335-9652-01 Bryant 30 tablets AA FDA listed
Glycopyrrolate 1 mg 72162-2597-01 Bryant 100 tablets AA FDA listed
Glycopyrrolate 1 mg 71335-2075-01 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 71335-3090-01 Bryant 30 tablets AA FDA listed
Glycopyrrolate 1 mgthis 59651-0737-81 Aurobindo 8000 tablets FDA listed
Glycopyrrolate 1 mg 63629-7207-01 Bryant 30 tablets AA FDA listed
Glycopyrrolate 1 mg 70518-4597-00 REMEDYREPACK 100 tablets AA FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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

Medicare Part D (outpatient prescription) spending for Glycopyrrolate (matched by generic name) — 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. CMS lists 3 products for this generic; we show the highest-spend one. 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.

🔬 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 Glycopyrrolate — the ingredient across all brands.

Top reported reactions

Dyspnoea3,566
Cough1,693
Device Delivery System Issue1,666
Death1,631
Asthma1,478
Wrong Technique In Device Usage Process1,317
Chronic Obstructive Pulmonary Disease1,210

Age at onset

Neonate23
Infant13
Child55
Adolescent26
Adult1,670
Elderly2,451

Reporter sex

19,422 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization4,741
Death2,286
Life-threatening641
Disabling296
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,124 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59651-0737-81 You're viewing this 8000 TABLET in 1 BAG (59651-737-81) Active

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Aurobindo Pharma Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 59651-737-81, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 59651-0737-81, written without dashes as 59651073781. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 59651-0737-81, the first segment (59651) is the labeler code FDA assigned to Aurobindo Pharma Limited; the middle segment (0737) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (81) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aurobindo Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aurobindo Pharma 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.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label 19 words

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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