Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Glimepiride 4 mg Tablet, 30-count — NDC 68788-4191-3 (Billing 68788-4191-03)
by Preferred Pharmaceuticals Inc. · 30 TABLET in 1 BOTTLE
This is a package of 30 tablets of Glimepiride 4 mg Tablet from Preferred Pharmaceuticals Inc., marketed since Sep 2026 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.
NDC 68788-4191-03
🏷️ FDA NDC (as labeled)
68788-4191-3
billing pads the package segment with a zero
This package
Contains30-count
Pack sizes3 compare ↓
Main listing for product 68788-4191 · Also comes in:
60 tablets 68788-4191-6
90 tablets 68788-4191-9
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 Glimepiride (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Jan 18, 2024 — Misprint on tablet (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0313-2024
Class III · Jan 18, 2024 — Misprint on tablet (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0312-2024
Class II · Mar 16, 2023 — CGMP Deviations (Northwind Pharmaceuticals LLC) · FDA recall D-0551-2023
Class II · Mar 16, 2023 — CGMP Deviations (Northwind Pharmaceuticals LLC) · FDA recall D-0552-2023
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)
68788-4191-3
Product NDC
68788-4191
11-digit billing NDC
68788419103
Application #
ANDA202112
SPL Set ID
aa533cde-4b32-450e-b080-127351524678
Established class (EPC)
Sulfonylurea
Chemical class
Sulfonylurea Compounds
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-09-24
Route
ORAL
Dosage form
TABLET
Substance
GLIMEPIRIDE
TE code (Orange Book)
AB · RLD · RS
Why two NDCs?
The FDA registers this code as 68788-4191-3 — a 5-4-1 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 package segment → 68788-4191-03. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
📗 Our plain-language guide HelloPharmacist
- Glimepiride helps lower your blood sugar if you have type 2 diabetes. It works by prompting your pancreas to release more insulin, which helps move sugar out of your bloodstream an...
- What exactly is glimepiride supposed to do for me?
- Yes, timing with food really matters here. You should take glimepiride with your breakfast or your first main meal of the day — every day. Taking it with a meal helps reduce the ri...
- When should I take it, and does it matter if I take it with food?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Glimepiride — tap one for details:
1
Nutrient depletion considerations
Glimepiride may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Glimepiride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 68788-4191-03 You're viewing this Main listing | 30 TABLET in 1 BOTTLE | 2026-09-24 | — | Active |
| 68788-4191-06 68788-4191-6 | 60 TABLET in 1 BOTTLE | 2026-09-24 | — | Active |
| 68788-4191-09 68788-4191-9 | 90 TABLET in 1 BOTTLE | 2026-09-24 | — | Active |
You're viewing the smallest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
This is a 30-count package — 30 tablet in 1 bottle.
How does this package differ from NDC 68788-4191-06?
Both are Glimepiride 4 mg Tablet — the drug itself is identical. This page's package is the 30-count one, while NDC 68788-4191-06 is the 60 tablets package.
What NDC number is used to bill for this package of Glimepiride 4 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Glimepiride 4 mg 16729-0003-01 | Accord | 100 tablets | $0.048 | AB | FDA listed | — |
| Glimepiride 4 mg 43547-0396-10 | Solco | 100 tablets | $0.051 | AB | Availability likely | — |
| Glimepiride 4 mg 55111-0322-01 | Dr. | 100 tablets | $0.051 | AB | Availability likely | — |
| Glimepiride 4 mg 71921-0216-01 | Florida | 100 tablets | $0.051 | AB | Availability likely | — |
| Glimepiride 4 mg 61442-0117-01 | Carlsbad | 100 tablets | $0.051 | AB | Availability likely | — |
| Glimepiride 4 mg 68084-0327-01 | American | 100 tablets | $0.051 | AB | Availability likely | — |
| Glimepiride 4 mg 42571-0103-01 | Micro | 100 tablets | $0.051 | AB | Availability likely | — |
| Glimepiride 4 mg 16571-0775-01 | Rising | 100 tablets | $0.051 | AB | Availability likely | — |
| Glimepiride 4 mg 50268-0360-15 | AvPAK | 50 tablets | $0.051 | AB | Availability likely | — |
| Glimepiride 4 mg 68001-0586-00 | BluePoint | 100 tablets | $0.051 | AB | Availability likely | — |
| Glimepiride 4 mg 00615-8334-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 63187-0486-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 71610-0236-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 50090-1006-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 50090-6322-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 50090-6852-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 60760-0800-90 | St. | 90 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 71205-0773-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 72789-0048-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 43063-0587-30 | PD-Rx | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 70518-4485-00 | REMEDYREPACK | 100 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 60429-0920-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 51655-0120-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 51655-0489-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 60760-0845-90 | ST. | 90 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 71335-0180-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 71335-2409-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 72189-0585-90 | Direct_rx | 90 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 50090-7823-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 68788-8432-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 71335-9654-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 43063-0699-90 | PD-Rx | 90 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 43063-0122-90 | PD-Rx | 90 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 50090-7406-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 68071-2228-06 | NuCare | 60 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 50090-7407-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mg 65862-0581-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| Glimepiride 4 mgthis 68788-4191-03 | Preferred | 30 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Color
White
ShapeOval
ImprintI;4
Size8 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.
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
-
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
-
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
6 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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerPreferred Pharmaceuticals Inc.
Application holderREGCON HOLDINGS LLC
FDA applicationANDA202112 (ANDA)
Labeler code68788
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio833 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
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 Glimepiride — the program that covers self-administered drugs. 10 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 Glimepiride. 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
$9.86M
Claims incl. refills
1M
Beneficiaries
804.7K
Spend / beneficiary
$12.26
Spend / claim
$9.57
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 Preferred Pharmaceuticals Inc.. 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 2 other package presentations of this same product, including 60 tablets (68788-4191-06), 90 tablets (68788-4191-09). 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?
Preferred Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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.