Metformin Hydrochloride 500 mg Tablet, Extended Release
by REMEDYREPACK INC. · 50 POUCH in 1 BOX (70518-4639-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4639-1)
NDC 70518-4639-00
🏷️ FDA NDC (as labeled)
70518-4639-0
billing pads the package segment with a zero
Rx only
Generic
On market
Non-controlled
🗂️ Data synced Sep 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 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
FDA NDC (as labeled)
70518-4639-0
Product NDC
70518-4639
11-digit billing NDC
70518463900
Application #
ANDA078321
SPL Set ID
ec43efb2-8a50-4bac-9576-f4303841a497
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
2026-04-27
Route
ORAL
Dosage form
TABLET, EXTENDED RELEASE
Substance
METFORMIN HYDROCHLORIDE
TE code (Orange Book)
AB1 · RLD · RS
Why two NDCs?
The FDA registers this code as 70518-4639-0 — 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 → 70518-4639-00. 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
LabelerREMEDYREPACK INC.
Application holderCSPC OUYI PHARMACEUTICAL CO LTD
FDA applicationANDA078321 (ANDA)
Labeler code70518
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio1,520 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
📗 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Metformin Hydrochloride — tap one for details:
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.
COENZYME Q10
Insignificant Depletion
FOLIC ACID
Moderate Depletion
VITAMIN B12
Moderate Depletion
THIAMINE
Insufficient Evidence
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.
💬 Questions about Metformin Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeOval
ImprintOE;584
Size19 mm
ScoringNot scored
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
-
UNII D9C330MD8B
Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
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.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metformin Hydrochloride 500 mg 42806-0632-01 | Epic | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 67877-0159-01 | Ascend | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride Er 500 mg 69315-0410-01 | Leading | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride Extended Release 500 mg 49483-0623-01 | TIME | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 42385-0977-01 | Laurus | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 50268-0550-15 | AvPAK | 1 tablet | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 67877-0413-01 | Ascend | 100 tablets | $0.029 | AB | Availability likely | — |
| Metformin Hydrochloride 500 mg 68094-0904-50 | Precision | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 82009-0180-05 | Quallent | 500 tablets | $0.029 | AB | Availability likely | — |
| Metformin Hydrochloride 500 mg 29300-0389-01 | Unichem | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 62756-0142-01 | Sun | 100 tablets | $0.029 | — | FDA listed | — |
| Metformin hydrochloride 500 mg 33342-0239-11 | Macleods | 100 tablets | $0.031 | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 51224-0007-50 | TAGI | 100 tablets | $0.031 | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 69367-0412-60 | Westminster | 60 tablets | $0.138 | AB2 | Availability likely | — |
| Metformin hydrochloride 500 mg 27241-0188-60 | Ajanta | 60 tablets | $0.138 | AB2 | Availability likely | — |
| Metformin Hydrochloride 500 mg 59651-0042-60 | Aurobindo | 60 tablets | $0.138 | AB2 | Availability likely | — |
| Metformin Hydrochloride 500 mg 42571-0333-01 | Micro | 100 tablets | $0.262 | AB3 | Availability likely | — |
| Metformin Hydrochloride 500 mg 68180-0338-01 | Lupin | 100 tablets | $0.262 | AB3 | Availability likely | — |
| Metformin Hydrochloride 500 mg 70010-0496-01 | Granules | 100 tablets | $0.262 | AB3 | Availability likely | — |
| Metformin hydrochloride 500 mg 27241-0240-01 | Ajanta | 100 tablets | $0.262 | AB3 | Availability likely | — |
| Metformin Hydrochloride 500 mg 68462-0520-01 | GLENMARK | 100 tablets | $0.262 | AB3 | Availability likely | — |
| Metformin hydrochloride 500 mg 68682-0021-50 | Oceanside | 100 tablets | $0.402 | — | FDA listed | — |
| Glumetza 500 mg 68012-0004-50 | Santarus, | 100 tablets | $49.542 | — | FDA listed | — |
| Metformin Hydrochloride 500 mg 43547-0503-10 | Solco | 100 tablets | — | AB3 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71205-0186-20 | Proficient | 20 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71205-0686-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Metformin Hydrochloride 500 mg 71610-0447-30 | Aphena | 30 tablets | — | — | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 71610-0454-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71610-0533-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 71610-0554-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71610-0578-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Metformin hydrochloride 500 mg 71610-0587-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71610-0652-30 | Aphena | 30 tablets | — | — | FDA listed | — |
| Metformin Hydrochloride Extended-Release 500mg 500 mg 17224-0311-28 | Calvin | 28 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 47335-0305-18 | Sun | 1000 tablets | — | — | Discontinued | — |
| Metformin Hydrochloride 500 mg 50090-5396-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-5397-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Metformin Hydrochloride 500 mg 71335-9683-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 72664-0227-01 | VGYAAN | 100 tablets | — | — | FDA listed | — |
| Metformin Hydrochloride 500 mg 00615-8289-39 | NCS | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 51655-0559-25 | Northwind | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 51655-0853-25 | Northwind | 60 tablets | — | AB | FDA listed | — |
| Metformin Hydrochloride 500 mg 65841-0027-01 | Zydus | 100 tablets | — | AB1 | Discontinued | — |
| Metformin Hydrochloride 500 mg 82804-0195-60 | Proficient | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 10135-0823-05 | Marlex | 500 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-7918-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 65162-0178-03 | Amneal | 30 tablets | — | — | FDA listed | — |
| Glumetza 500 mg 68012-0002-13 | Santarus, | 100 tablets | — | — | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 68071-3111-02 | NuCare | 120 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71610-0837-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 72578-0035-01 | Viona | 100 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 72789-0105-01 | PD-Rx | 100 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 76385-0128-01 | UNICHEM | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 67296-1701-06 | RedPharm | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 68180-0336-01 | Lupin | 100 tablets | — | AB2 | FDA listed | — |
| Metformin Hydrochloride 500 mg 69238-2125-01 | Amneal | 100 tablets | — | — | FDA listed | — |
| Metformin Hydrochloride 500 mg 72789-0455-30 | PD-Rx | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71335-0886-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 71610-0858-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 72789-0400-01 | PD-Rx | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-7579-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 63187-0779-00 | Proficient | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 25000-0101-03 | MARKSANS | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-7576-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 59651-0548-25 | Aurobindo | 25000 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 62207-0496-47 | Granules | 500 tablets | — | AB3 | FDA listed | — |
| Metformin Hydrochloride 500 mg 68788-8814-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 42291-0825-10 | AvKARE | 1000 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-1494-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-7116-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 68788-8866-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 68788-8903-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 72189-0064-30 | direct | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 72789-0454-60 | PD-Rx | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-7577-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71335-2568-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 42708-0201-60 | QPharma | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 51655-0555-96 | Northwind | 180 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 68071-1419-02 | NuCare | 20 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 71335-0293-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71335-0720-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 72189-0150-30 | direct | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 72789-0009-30 | PD-Rx | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71335-3166-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 67296-2305-09 | Redpharm | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mgthis 70518-4639-00 | REMEDYREPACK | 1 tablet | — | AB1 | 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
🏛️
2026
On the market since
Apr 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.
🔬 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 Metformin hydrochloride — the ingredient across all brands.
Top reported reactions
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70518-4639-00 You're viewing this | 50 POUCH in 1 BOX (70518-4639-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4639-1) | 2026-04-27 | Active |
🧭 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 FDA registers it as 70518-4639-0, 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: 70518-4639-00, written without dashes as 70518463900. 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 70518-4639-00, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (4639) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REMEDYREPACK 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.
📄 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 ↗
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.