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topcare lansoprazole 15 mg Capsule, Delayed Release — NDC 36800-392-03 (Billing 36800-0392-03)

by Topco Associates LLC · 3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

This is a package of topcare lansoprazole 15 mg Capsule, Delayed Release from Topco Associates LLC, marketed since Jul 2021 and currently FDA-listed.

NDC 36800-0392-03
🏷️ FDA NDC (as labeled) 36800-392-03 billing pads the product segment with a zero
This package
Contains14 capsule, delayed release in 1 bottle Pack sizes2 compare ↓
Product page 36800-0392-01 Also comes in: 14 capsules 36800-392-01
OTC 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-392-03
Product NDC 36800-392
11-digit billing NDC 36800039203
RxCUI 596843
UNII 0K5C5T2QPG
Application # ANDA202319
SPL Set ID 73aec019-5337-48a4-b95c-993fff9cfc2a
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Proton Pump Inhibitors
Physiologic effect Inhibition Gastric Acid Secretion
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-07-29
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance LANSOPRAZOLE
Quick answers
  • RxCUI (RxNorm): 596843
Why two NDCs? The FDA registers this code as 36800-392-03 — 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 → 36800-0392-03. 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.

RxNorm drug class

This medicine belongs to the Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors
How it works Proton Pump Inhibitors
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

📗 Our plain-language guide HelloPharmacist
  • It lowers stomach acid. Prescription forms treat ulcers, GERD, erosive esophagitis and conditions with too much acid. It is also used with antibiotics for H. pylori. Over-the-count...
  • Take it once a day, before eating, usually in the morning. Swallow capsules whole. Let orally disintegrating tablets dissolve on your tongue without chewing. For over-the-counter u...
  • For heartburn, the over-the-counter label says full effect can take 1 to 4 days, though some people feel relief within 24 hours. It is not meant for instant relief.
  • The most common are diarrhea, belly pain, nausea and constipation. Call your doctor if you get a severe rash, swelling, trouble breathing, diarrhea that will not clear, or muscle s...
📖 Read our full Lansoprazole guide →
9
Nutrient depletion considerations

Lansoprazole may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Lansoprazole 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 · 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.
Try another pack size: 14 capsules
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
36800-0392-01 36800-392-01 Main listing 1 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 2021-07-29 — Active
36800-0392-03 You're viewing this 3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 2021-07-29 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 3 bottle in 1 carton / 14 capsule, delayed release in 1 bottle.
What NDC number is used to bill for this package of topcare lansoprazole 15 mg Capsule, Delayed Release?
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
Lansoprazole 15 mg 00093-7350-56 Teva 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 00378-8015-93 Mylan 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 60687-0111-21 American 1 capsule $0.147 AB Availability likely —
Lansoprazole 15 mg 67877-0274-30 Ascend 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 68001-0111-04 BluePoint 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 70756-0806-30 Lifestar 30 capsules $0.147 AB Availability likely —
Good Sense Lansoprazole 15 mg 00113-1114-01 L. 14 capsules $0.407 — Availability likely —
Lansoprazole 15 mg 00536-1368-13 Rugby 14 capsules $0.407 — Availability likely —
lansoprazole 15 mg 45802-0878-01 Padagis 14 capsules $0.407 — Availability likely —
good neighbor pharmacy lansoprazole 15 mg 46122-0698-04 Amerisource 14 capsules $0.407 — Availability likely —
Lansoprazole 15 mg 46122-0744-04 AMERISOURCEBERGEN 14 capsules $0.407 — Availability likely —
foster and thrive acid reducer 15 mg 70677-1103-01 Strategic 14 capsules $0.407 — Availability likely —
Lansoprazole 15 mg 83324-0001-14 Chain 14 capsules $0.407 — Availability likely —
Lansoprazole 15 mg 70000-0612-01 LEADER/ 14 capsules $0.432 — FDA listed —
Prevacid 24 HR 15 mg 00113-6117-01 L. 14 capsules — — FDA listed —
Lansoprazole 15 mg 00363-0037-14 Walgreens 14 capsules — — FDA listed —
lansoprazole 15 mg 00363-1212-01 Walgreen 14 capsules — — FDA listed —
up and up lansoprazole 15 mg 11673-0280-01 Target 14 capsules — — FDA listed —
Lansoprazole 15 mg 11673-0324-42 Target 14 capsules — — Discontinued —
Lansoprazole 15 mg 11822-0019-01 Rite 14 capsules — — Discontinued —
Lansoprazole 15 mg 11822-3374-05 Rite 14 capsules — — FDA listed —
Lansoprazole 15 mg 21130-0046-14 Albertsons 14 capsules — — Discontinued —
signature care acid reducer 15 mg 21130-0181-01 Safeway 14 capsules — — Discontinued —
Lansoprazole 15 mg 27241-0019-03 Ajanta 30 capsules — — FDA listed —
Lansoprazole 15 mg 30142-0983-14 Kroger 14 capsules — — Discontinued —
Lansoprazole 15 mg 31722-0570-01 Camber 100 capsules — AB FDA listed —
Lansoprazole 15 mg 33342-0310-07 Macleods 30 capsules — — FDA listed —
topcare lansoprazole 15 mgthis 36800-0392-03 Topco 14 capsules — — FDA listed —
Lansoprazole 15 mg 37808-0934-14 H 14 capsules — — Discontinued —
equaline lansoprazole 15 mg 41163-0150-01 United 14 capsules — — FDA listed —
lansoprazole 15 mg 41250-0391-01 Meijer 14 capsules — — FDA listed —
Lansoprazole 15 mg 43598-0109-27 Dr. 14 capsules — — FDA listed —
Lansoprazole 15 mg 43598-0161-33 Dr. 14 capsules — — FDA listed —
equate lansoprazole delayed release 15 mg 49035-0411-01 Wal-Mart 14 capsules — — FDA listed —
Lansoprazole 15 mg 50090-6079-00 A-S 30 capsules — AB FDA listed —
Lansoprazole 15 mg 51316-0006-14 CVS 14 capsules — — Discontinued —
Lansoprazole 15 mg 55111-0398-01 Dr.Reddy's 100 capsules — AB FDA listed —
Lansoprazole 15 mg 55111-0739-27 Dr. 14 capsules — — FDA listed —
dg health lansoprazole 15 mg 55910-0307-01 Dolgencorp 14 capsules — — FDA listed —
lansoprazole 15 mg 56062-0117-01 Publix 14 capsules — — FDA listed —
lansoprazole 15 mg 56062-0283-01 Publix 14 capsules — — FDA listed —
Kirkland Signature Lansoprazole 15 mg 63981-0582-03 Costco 14 capsules — — FDA listed —
Lansoprazole 15 mg 68071-2274-06 NuCare 60 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-3633-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-3634-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-3687-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-4456-06 NuCare 60 capsules — AB FDA listed —
Lansoprazole 15 mg 68196-0045-03 Sam's 14 capsules — — Discontinued —
Members Mark Lansoprazole 15 mg 68196-0279-03 Sam's 14 capsules — — FDA listed —
Berkley And Jensen Lansoprazole 15 mg 68391-0823-03 BJWC 14 capsules — — FDA listed —
Lansoprazole 15 mg 68788-6390-01 Preferred 100 capsules — AB FDA listed —
Lansoprazole 15 mg 69842-0755-14 CVS 14 capsules — — FDA listed —
Lansoprazole 15 mg 70700-0262-30 Xiromed 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-0058-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-2957-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-9680-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-9693-01 Bryant 30 capsules — AB FDA listed —
lansoprazole 15 mg 71335-9695-01 Bryant 30 capsules — — FDA listed —
basic care lansoprazole 15 mg 72288-0301-01 Amazon.com 14 capsules — — FDA listed —
basic care lansoprazole 15 mg 72288-0343-01 Amazon.com 14 capsules — — FDA listed —
careone acid reducer 15 mg 72476-0020-01 Retail 14 capsules — — Discontinued —
equate lansoprazole 15 mg 79903-0068-01 WALMART 14 capsules — — FDA listed —
Lansoprazole DR 15 mg 80425-0148-01 Advanced 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-2734-06 NuCare 60 capsules — AB FDA listed —
Lansoprazole 15 mg 72288-0827-03 Amazon.com 14 capsules — — 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

🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 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.

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

LabelerTopco Associates LLC
Application holderPERRIGO R AND D CO
FDA applicationANDA202319 (ANDA)
Labeler code36800
First marketedJul 2021
Product typeHuman Otc Drug
Portfolio408 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 label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

⏱️ Dosage and Administration 166 words ▾

Directions • adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment • swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use.

Heartburn in children may sometimes be caused by a serious condition.

⚠️ Warnings ~1 min read ▾

Warnings Allergy alert: • do not use if you are allergic to lansoprazole • lansoprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools. • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition.

See your doctor. Ask a doctor before use if you have • liver disease • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are • taking a prescription drug.

Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📦 Storage and Handling 43 words ▾

Other information • read the directions and warnings before use • keep the carton. It contains important information. • store at 20-25°C (68-77°F) • keep product out of high heat and humidity • protect product from moisture • close cap tightly after use

🧪 Active Ingredient 8 words ▾

Active ingredient (in each capsule) Lansoprazole 15 mg

🧪 Inactive Ingredients 43 words ▾

Inactive ingredients D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide

🎯 Purpose 3 words ▾

Purpose Acid Reducer

📄 Do Not Use 62 words ▾

Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools. • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor.

📄 Ask a Doctor Before Use If 44 words ▾

Ask a doctor before use if you have • liver disease • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain

📄 Ask a Doctor or Pharmacist Before Use If 23 words ▾

Ask a doctor or pharmacist before use if you are • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

📄 Stop Use and Ask a Doctor If 51 words ▾

Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast-feeding, ask a health care professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📄 Questions or Comments 4 words ▾

Questions or comments? 1-888-423-0139

📄 Package Label / Principal Display Panel 51 words ▾

Package/Label Principal Display Panel TopCare ® health COMPARE TO PREVACID ® 24 HR ACTIVE INGREDIENT Lansoprazole DELAYED-RELEASE CAPSULES 15 mg ACID REDUCER TREATS FREQUENT HEARTBURN 24 HOUR • May take 1 to 4 Days for Full Effect • Sodium Free 42 CAPSULES • THREE 14-DAY COURSES OF TREATMENT actual size topcare-lansoprazole-carton-image.jpg

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 Lansoprazole (matched by generic name) — the program that covers self-administered drugs. 13 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 Lansoprazole. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.11M
Claims incl. refills
326.1K
Beneficiaries
241.2K
Spend / beneficiary
$46.07
Spend / claim
$34.08
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

Over-the-counter (OTC) 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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 Topco Associates 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 1 other package presentation of this same product, including 14 capsules (36800-0392-01). 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?
Topco Associates 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
← 36800-0391-08 · Topco 36800-0395-01 · TOP →
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.