Home › NDC Lookup › Ingredients › Metformin Hydrochloride › 43353-0982-70
Metformin Hydrochloride 500 mg Tablet, 120-count — NDC 43353-0982-70 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Metformin Hydrochloride 500 mg Tablet, 120-count — NDC 43353-982-70 (Billing 43353-0982-70)

by Aphena Pharma Solutions - Tennessee, LLC · 120 TABLET in 1 BOTTLE

This is a package of 120 tablets of Metformin Hydrochloride 500 mg Tablet from Aphena Pharma Solutions - Tennessee, LLC, marketed since Sep 2013 and currently FDA-listed.

NDC 43353-0982-70
🏷️ FDA NDC (as labeled) 43353-982-70 billing pads the product segment with a zero
This package
Contains120-count Pack sizes8 compare ↓
Also priced by: Part D plans $0.0671/unit — full pricing hub ↓
Product page 43353-0982-30 Also comes in: 30 tablets 43353-982-30 60 tablets 43353-982-53 90 tablets 43353-982-60 180 tablets 43353-982-80 270 tablets 43353-982-92 360 tablets 43353-982-94 450 tablets 43353-982-96
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 Metformin Hydrochloride (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0328-2025
Class II · Feb 25, 2025 — Presence of Foreign Tablets/Capsules. (A-S Medication Solutions LLC) · FDA recall D-0292-2025
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) 43353-982-70
Product NDC 43353-982
11-digit billing NDC 43353098270
NCPDP billing unit EA — each (per item)
RxCUI 861004, 861007, 861010
UNII 786Z46389E
Application # ANDA203769
SPL Set ID 273d86b0-9d30-48c9-8918-c5e1ececa951
Established class (EPC) Biguanide
Chemical class Biguanides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-09-11
Route ORAL
Dosage form TABLET
Substance METFORMIN HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 27250050000320
GPI class metFORMIN HCl
GCN Seq No 013318
GCN 10810
HICL code 004763
Ingredient (HICL) Metformin Hcl
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4L
Therapeutic class — specific (HIC3) Antihyperglycemic, Biguanide Type
AHFS code 68:20.04.00
AHFS class Biguanides
FDB label name METFORMIN HCL 500 MG TABLET
FDB brand name Metformin Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 013318
  • GCN: 10810
  • GPI-14 (Medi-Span): 27250050000320
  • HICL (First Databank): 004763
  • AHFS class code: 68:20.04.00
  • RxCUI (RxNorm): 861004
Why two NDCs? The FDA registers this code as 43353-982-70 — 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 → 43353-0982-70. 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 Biguanide class.

Pharmacologic class Biguanide
Drug family (ATC) Biguanides
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 METFORMIN HCL 500 MG TABLET Ingredient Metformin Hcl
📗 Our plain-language guide HelloPharmacist
  • Metformin works in three ways: it lowers the amount of sugar your liver dumps into your bloodstream, slows how much sugar your gut absorbs from food, and helps your body respond to...
  • What exactly is metformin doing for my diabetes?
  • Yes, this is very common — diarrhea, nausea, and stomach discomfort are the most frequently reported side effects, and they're often worst when you first start or when your dose go...
  • My stomach has been a mess since I started metformin. Is that normal? Will it get better?
📖 Read our full Metformin guide →
4
Nutrient depletion considerations

Metformin Hydrochloride may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Metformin Hydrochloride nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0671 $8.05 / 120 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
43353-0982-30 43353-982-30 Main listing 30 TABLET in 1 BOTTLE 2014-11-11 — Active
43353-0982-53 43353-982-53 60 TABLET in 1 BOTTLE 2015-11-16 — Active
43353-0982-60 43353-982-60 90 TABLET in 1 BOTTLE 2015-05-13 — Active
43353-0982-80 43353-982-80 180 TABLET in 1 BOTTLE 2015-05-12 — Active
43353-0982-92 43353-982-92 270 TABLET in 1 BOTTLE 2015-05-12 — Active
43353-0982-94 43353-982-94 360 TABLET in 1 BOTTLE 2015-05-12 — Active
43353-0982-96 43353-982-96 450 TABLET in 1 BOTTLE 2015-03-28 — Active
43353-0982-70 You're viewing this 120 TABLET in 1 BOTTLE 2019-05-14 — Active

You're viewing one of 8 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 120-count package — 120 tablet in 1 bottle.
How does this package differ from NDC 43353-0982-30?
Both are Metformin Hydrochloride 500 mg Tablet — the drug itself is identical. This page's package is the 120-count one, while NDC 43353-0982-30 is the 30 tablets package.
What NDC number is used to bill for this package of Metformin Hydrochloride 500 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
Metformin Hydrochloride 500 mg 71093-0132-04 ACI 100 tablets $0.014 AB Availability likely —
Metformin Hydrochloride 500 mg 00378-7185-05 Mylan 500 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 00904-7162-61 Major 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 23155-0841-01 Heritage 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 42385-0947-01 Laurus 100 tablets $0.015 AB Availability likely —
Metformin HCl 500 mg 49483-0622-01 TIME 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 59651-0854-01 Aurobindo 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 60687-0155-01 American 1 tablet $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 62135-0680-05 Chartwell 500 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 65862-0008-01 Aurobindo 100 tablets $0.015 AB Availability likely —
Metformin HCl 500 mg 67877-0561-01 Ascend 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 67877-0930-01 Ascend 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 68094-0688-60 Precision 500 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 68382-0758-01 Zydus 100 tablets $0.015 AB Availability likely —
Metformin hydrochloride 500 mg 68645-0582-59 Legacy 60 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 69367-0180-01 Westminster 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 69367-0381-01 Westminster 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 70010-0063-01 Granules 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 82009-0046-10 Quallent 1000 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 82009-0174-10 Quallent 1000 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 83301-0008-01 Mullan 100 tablets $0.015 AB Availability likely —
Metformin Hydrochloride 500 mg 24658-0790-01 PuraCap 100 tablets $0.017 AB FDA listed —
Metformin Hydrochloride 500 mg 00615-8015-05 NCS 15 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 00615-8629-05 NCS 15 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 25000-0134-03 MARKSANS 30 tablets — AB FDA listed —
Metformin hydrochloride 500 mg 33342-0141-10 Macleods 90 tablets — — FDA listed —
Metformin HCl 500 mg 42708-0009-60 QPharma, 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 42806-0313-01 Epic 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 43063-0527-14 PD-Rx 14 tablets — — FDA listed —
Metformin Hydrochloride 500 mgthis 43353-0982-70 Aphena 120 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-2081-00 A-S 60 tablets — AB FDA listed —
Metformin HCl 500 mg 50090-3064-00 A-S 60 tablets — AB FDA listed —
Metformin HCl 500 mg 50090-4891-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-6485-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-6858-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-6859-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7010-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7011-00 A-S 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7013-00 A-S 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7278-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7280-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7595-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-7597-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50228-0105-00 ScieGen 9000 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 51655-0556-25 Northwind 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 53746-0218-01 Amneal 100 tablets — — FDA listed —
Metformin Hydrochloride 500 mg 55154-4172-00 Cardinal 10 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 60429-0111-01 Golden 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 62207-0440-43 Granules 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 63187-0238-90 Proficient 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 63629-8501-01 Bryant 500 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 63629-8502-01 Bryant 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 67046-0298-03 Coupler 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 67046-1594-03 Coupler 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 67877-0217-01 Ascend 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-3518-08 NuCare 180 tablets — AB FDA listed —
Metformin HCl 500 mg 68071-3541-06 NuCare 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-3739-01 NuCare 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-3900-06 NuCare 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-4076-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-8498-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-8564-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68788-8652-01 Preferred 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 70518-1149-01 REMEDYREPACK 1 tablet — AB Discontinued —
Metformin Hydrochloride 500 mg 70518-1951-01 REMEDYREPACK 30 tablets — AB Discontinued —
Metformin Hydrochloride 500 mg 70518-2833-00 REMEDYREPACK 30 tablets — AB FDA listed —
Metformin HCl 500 mg 70882-0124-56 Cambridge 56 tablets — AB Discontinued —
Metformin HCl 500 mg 71205-0562-00 Proficient 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71205-0622-30 Proficient 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71205-0784-30 Proficient 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71205-0882-00 Proficient 100 tablets — AB FDA listed —
Metformin HCl 500 mg 71335-1072-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71335-1834-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71335-2224-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71335-2466-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71335-3132-00 Bryant 25 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71610-0917-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71610-0920-53 Aphena 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71610-0929-30 Aphena 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 71709-0110-06 Metcure 500 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 72162-1522-01 Bryant 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 72189-0219-30 direct 30 tablets — AB FDA listed —
Metformin HCL 500 mg 72189-0617-30 Direct_Rx 30 tablets — AB FDA listed —
Metformin HCL 500 mg 72189-0658-30 Direct_Rx 30 tablets — AB FDA listed —
Metformin HCl 500 mg 72789-0192-20 PD-Rx 20 tablets — AB FDA listed —
Metformin HCl 500 mg 72789-0531-42 PD-Rx 42 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 72789-0561-20 PD-Rx 20 tablets — AB FDA listed —
Metformin HCl 500 mg 82868-0049-90 Northwind 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 65841-0809-01 Zydus 100 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 70518-4698-00 REMEDYREPACK 30 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-5306-08 NuCare 180 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 82804-0309-78 Proficient 180 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 42708-0203-60 QPharma,Inc. 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-8041-00 A-S 60 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 50090-8043-00 A-S 90 tablets — AB FDA listed —
Metformin Hydrochloride 500 mg 68071-5323-06 NuCare 60 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

🏛️
2013
On the market since
Sep 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

What it looks like

Color white
ShapeOval
ImprintS;G;1;07
Size19 mm
ScoringScored — splits in 2
FlavorBlackberry
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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA203769 (ANDA)
Labeler code43353
First marketedSep 2013
Product typeHuman Prescription Drug
Portfolio800 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning ~3 min read ▾

Lactic Acidosis Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin hydrochloride tablets; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio.

When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 mcg/mL are generally found. The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis.

Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age.

The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin hydrochloride tablets and by use of the minimum effective dose of metformin hydrochloride tablets. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin hydrochloride tablet treatment should not be initiated in patients > 80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis.

In addition, metformin hydrochloride tablets should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, metformin hydrochloride tablets should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking metformin hydrochloride tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism.

In addition, metformin hydrochloride tablets should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS ). The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis.

The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS ). Metformin hydrochloride tablets should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose, and if indicated, blood pH, lactate levels, and even blood metformin levels may be useful.

Once a patient is stabilized on any dose level of Metformin hydrochloride tablets, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointes…

🎯 Indications and Usage 28 words ▾

INDICATIONS AND USAGE Metformin hydrochloride tablet are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin or any other pharmacologic agent. Dosage of metformin must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin hydrochloride tablets is 2550 mg in adults and 2000 mg in pediatric patients (10 to 16 years of age).

Metformin hydrochloride tablets should be given in divided doses with meals. Metformin hydrochloride tablets should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration (see Recommended Dosing Schedule ), fasting plasma glucose should be used to determine the therapeutic response to metformin hydrochloride tablets and identify the minimum effective dose for the patient.

Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin hydrochloride tablets, either when used as monotherapy or in combination with sulfonylurea or insulin. Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.

Short-term administration of metformin may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone. Recommended Dosing Schedule Adults In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms.

The usual starting dose of metformin hydrochloride tablets is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every two weeks, up to a total of 2000 mg per day, given in divided doses. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after two weeks.

For those patients requiring additional glycemic control, metformin hydrochloride tablets may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals. Pediatrics The usual starting dose of metformin hydrochloride tablets is 500 mg twice a day, given with meals.

Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses. Transfer from Other Antidiabetic Therapy When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

Concomitant Metformin and Oral Sulfonylurea Therapy in Adult Patients If patients have not responded to four weeks of the maximum dose of metformin monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide). With concomitant metformin and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting t…

⛔ Contraindications 112 words ▾

CONTRAINDICATIONS Metformin hydrochloride tablets are contraindicated in patients with: Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ). Known hypersensitivity to metformin hydrochloride. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

Diabetic ketoacidosis should be treated with insulin. Metformin hydrochloride tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function (see also PRECAUTIONS ).

⚠️ Warnings ~3 min read ▾

WARNINGS Lactic Acidosis: Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin hydrochloride tablets; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio.

When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 µg/mL are generally found. The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/ 1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis.

Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient’s age.

The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin hydrochloride tablets and by use of the minimum effective dose of metformin hydrochloride tablets. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin hydrochloride tablets treatment should not be initiated in patients ≥80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis.

In addition, metformin hydrochloride tablets should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, metformin hydrochloride tablets should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking metformin hydrochloride tablets, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism.

In addition, metformin hydrochloride tablets should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS ). The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis.

The patient and the patient’s physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS ). Metformin hydrochloride tablets should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose, and if indicated, blood pH, lactate levels, and even blood metformin levels may be useful.

Once a patient is stabilized on any dose level of metformin hydrochloride tablets, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of g…

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS In a US double-blind clinical study of metformin hydrochloride tablets in patients with type 2 diabetes, a total of 141 patients received metformin hydrochloride tablets therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the metformin hydrochloride tablets patients, and those were more common in metformin hydrochloride tablets- than placebo-treated patients, are listed in Table 7 . Table 7: Most Common Adverse Reactions (>5.0 Percent) in a Placebo-Controlled Clinical Study of Metformin Hydrochloride Tablets Monotherapy Reactions those were more common in metformin - than placebo-treated patients.

Adverse Reaction Metformin HCl Monotherapy (n=141) Placebo (n=145) % of Patients Diarrhea 53.2

11.7Nausea/Vomiting 25.5

8.3Flatulence 12.1

5.5Asthenia 9.2

5.5Indigestion 7.1

4.1Abdominal Discomfort 6.4

4.8Headache 5.7

4.8Diarrhea led to discontinuation of study medication in 6% of patients treated with metformin hydrochloride tablets. Additionally, the following adverse reactions were reported in ≥ 1.0 - ≤ 5.0% of metformin hydrochloride tablets patients and were more commonly reported with metformin hydrochloride tablets than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation. Pediatric Patients In clinical trials with metformin hydrochloride tablets in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.

🤰 Pregnancy 1 words ▾

Pregnancy

🧒 Pediatric Use 144 words ▾

Pediatric Use The safety and effectiveness of metformin hydrochloride tablets for the treatment of type 2 diabetes have been established in pediatric patients ages 10 to 16 years (studies have not been conducted in pediatric patients below the age of 10 years). Use of metformin hydrochloride tablets in this age group is supported by evidence from adequate and well-controlled studies of metformin hydrochloride tablets in adults with additional data from a controlled clinical study in pediatric patients ages 10 to 16 years with type 2 diabetes, which demonstrated a similar response in glycemic control to that seen in adults (see CLINICAL PHARMACOLOGY : Pediatric Clinical Studies ).

In this study, adverse effects were similar to those described in adults (see ADVERSE REACTIONS : Pediatric Patients). A maximum daily dose of 2000 mg is recommended (see DOSAGE AND ADMINISTRATION : Recommended Dosing Schedule: Pediatrics ).

🧓 Geriatric Use 148 words ▾

Geriatric Use Controlled clinical studies of metformin did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and younger patients. Metformin is known to be substantially excreted by the kidney and because the risk of serious adverse reactions to the drug is greater in patients with impaired renal function, metformin should only be used in patients with normal renal function (see CONTRAINDICATIONS , WARNINGS, and CLINICAL PHARMACOLOGY : Pharmacokinetics ).

Because aging is associated with reduced renal function, metformin should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function. Generally, elderly patients should not be titrated to the maximum dose of metformin (see also WARNINGS and DOSAGE AND ADMINISTRATION ).

🆘 Overdosage 81 words ▾

OVERDOSAGE Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see WARNINGS ).

Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS ) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease. Pharmacokinetics Absorption and Bioavailability The absolute bioavailability of a metformin hydrochloride 500 mg tablet given under fasting conditions is approximately 50 to 60%.

Studies using single oral doses of metformin hydrochloride 500 mg to 1500 mg, and 850 mg to 2550 mg, indicate that there is a lack of dose proportionality with increasing doses, which is due to decreased absorption rather than an alteration in elimination. Food decreases the extent of and slightly delays the absorption of metformin, as shown by approximately a 40% lower mean peak plasma concentration (C max ), a 25% lower area under the plasma concentration versus time curve (AUC), and a 35-minute prolongation of time to peak plasma concentration (T max ) following administration of a single 850 mg tablet of metformin with food, compared to the same tablet strength administered fasting.

The clinical relevance of these decreases is unknown. Distribution The apparent volume of distribution (V/F) of metformin following single oral doses of metformin hydrochloride tablets 850 mg averaged 654 ± 358 L. Metformin is negligibly bound to plasma proteins, in contrast to sulfonylureas, which are more than 90% protein bound.

Metformin partitions into erythrocytes, most likely as a function of time. At usual clinical doses and dosing schedules of metformin hydrochloride tablets, steady state plasma concentrations of metformin are reached within 24 to 48 hours and are generally <1 mcg/mL. During controlled clinical trials of metformin hydrochloride tablets, maximum metformin plasma levels did not exceed 5 mcg/mL, even at maximum doses.

Metabolism and Elimination Intravenous single-dose studies in normal subjects demonstrate that metformin is excreted unchanged in the urine and does not undergo hepatic metabolism (no metabolites have been identified in humans) nor biliary excretion. Renal clearance (see Table 1 ) is approximately 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination. Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours.

In blood, the elimination half-life is approximately 17.6 hours, suggesting that the erythrocyte mass may be a compartment of distribution. Special Populations Patients with Type 2 Diabetes In the presence of normal renal function, there are no differences between single- or multiple-dose pharmacokinetics of metformin between patients with type 2 diabetes and normal subjects (see Table 1 ), nor is there any accumulation of metformin in either group at usual clinical doses. Renal Insufficiency In patients with decreased renal function (based on measured creatinine clearance), the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased in proportion to the decrease in creatinine clearance (see Table 1; also see WARNINGS ).

Hepatic Insufficiency No pharmacokinetic studies of metformin have been conducted in patients with hepatic insufficiency. Geriatrics Limit…

🧬 Mechanism of Action 108 words ▾

Mechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS ) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.

📦 How Supplied / Storage and Handling ~3 min read ▾

HOW SUPPLIED Metformin Hydrochloride Tablets are available as follows: Metformin Hydrochloride Tablets, USP 500 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘105’ on other side. 500 mg: Bottles of 60 NDC 60429-111-60 Bottles of 90 NDC 60429-111-90 Bottles of 100 NDC 60429-111-01 Bottles of 120 NDC 60429-111-12 Bottles of 180 NDC 60429-111-18 Bottles of 270 NDC 60429-111-27 Bottles of 360 NDC 60429-111-36 Bottles of 450 NDC 60429-111-45 Bottles of 1000 NDC 60429-111-10 Metformin Hydrochloride Tablets, USP 850 mg are blackberry flavored, white to off-white, round, biconvex, beveled edge film coated tablets, debossed with ‘SG’ on one side ‘106’ on other side.

850 mg: Bottles of 60 NDC 60429-112-60 Bottles of 90 NDC 60429-112-90 Bottles of 100 NDC 60429-112-01 Bottles of 180 NDC 60429-112-18 Bottles of 270 NDC 60429-112-27 Bottles of 500 NDC 60429-112-05 Metformin Hydrochloride Tablets, USP 1000 mg tablets are blackberry flavored, white to off-white, oval, biconvex, film coated tablets debossed on one side with S on the left side of bisect and G on the right side of bisect and other side 1 on the left side and 07 on the right side of the bisect. 1000 mg: Bottles of 60 NDC 60429-113-60 Bottles of 90 NDC 60429-113-90 Bottles of 180 NDC 60429-113-18 Bottles of 500 NDC 60429-113-05 Bottles of 1000 NDC 60429-113-10 Storage Store at 20°to 25° C (68°to 77° F); excursions permitted to 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP.

Manufactured by: Sciegen Pharmaceuticals, Inc Hauppauge, NY 11788 Marketed/Packaged by: GSMS, Inc. Camarillo, CA 93012 Rev: 08/13 Rx Only Patient Information METFORMIN HYDROCHLORIDE TABLETS, USP Read this information carefully before you start taking this medicine and each time you refill your prescription. There may be new information.

This information does not take the place of your doctor’s advice. Ask your doctor or pharmacist if you do not understand some of this information or if you want to know more about this medicine. What are metformin hydrochloride tablets?

Metformin hydrochloride tablets are used to treat type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus. People with type 2 diabetes are not able to make enough insulin or respond normally to the insulin their bodies make.

When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease.

The main goal of treating diabetes is to lower your blood sugar to a normal level. High blood sugar can be lowered by diet and exercise, by a number of medicines taken by mouth, and by insulin shots. Before you take metformin hydrochloride tablets, try to control your diabetes by exercise and weight loss.

While you take your diabetes medicine, continue to exercise and follow the diet advised for your diabetes. No matter what your recommended diabetes management plan is, studies have shown that maintaining good blood sugar control can prevent or delay complications of diabetes, such as blindness. Metformin hydrochloride tablets help control your blood sugar in a number of ways.

These include helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb. Metformin hydrochloride tablets do not cause your body to make more insulin. Because of this, when taken alone, they rarely cause hypoglycemia (low blood sugar), and usually do not cause weight gain.

However, when they are taken with a sulfonylurea or with insulin, hypoglycemia is more likely to occur, as is weight gain. WARNING: A small number of people who have taken metformin hydrochloride tablets have developed a serious condition called lactic acidosis. Lactic acidosi…

📋 Description 162 words ▾

DESCRIPTION Metformin Hydrochloride Tablets USP, are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride is a white crystalline compound with a molecular formula of C 4 H 11 N 5 • HCl and a molecular weight of 165.63.

Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.

Each Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains hypromellose polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide.

Chemical Structure

💬 Information for Patients 219 words ▾

Information for Patients Patients should be informed of the potential risks and benefits of metformin and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, glycosylated hemoglobin, renal function, and hematologic parameters. The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the WARNINGS and PRECAUTIONS sections, should be explained to patients.

Patients should be advised to discontinue metformin immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of metformin, gastrointestinal symptoms, which are common during initiation of metformin therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.

Patients should be counseled against excessive alcohol intake, either acute or chronic, while receiving metformin. Metformin alone does not usually cause hypoglycemia, although it may occur when metformin is used in conjunction with oral sulfonylureas and insulin. When initiating combination therapy, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members (see Patient Information printed below).

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

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 Aphena Pharma Solutions - Tennessee, 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 7 other package presentations of this same product, including 30 tablets (43353-0982-30), 60 tablets (43353-0982-53), 90 tablets (43353-0982-60). 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?
Aphena Pharma Solutions - Tennessee, 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.
← 43353-0979-30 · Aphena 43353-0986-60 · Aphena →
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.