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Loperamide Hydrochloride 2 mg Tablet, 24-count — NDC 84386-117-24 (Billing 84386-0117-24)

by Aurobindo Pharma Limited · 4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

This is a package of 24 tablets of Loperamide Hydrochloride 2 mg Tablet from Aurobindo Pharma Limited, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 84386-0117-24
🏷️ FDA NDC (as labeled) 84386-117-24 billing pads the product segment with a zero
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) 84386-117-24
Product NDC 84386-117
11-digit billing NDC 84386011724
RxCUI 978010
UNII 77TI35393C
Application # ANDA206548
SPL Set ID 8e4004be-bf79-4631-9e38-c4e7b6726313
Established class (EPC) Opioid Agonist
Mechanism of action Opioid Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-03
Route ORAL
Dosage form TABLET
Substance LOPERAMIDE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 978010
Why two NDCs? The FDA registers this code as 84386-117-24 — 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 → 84386-0117-24. 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 Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Antipropulsives
How it works Opioid Agonists
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

📖 What it is MedlinePlus · NLM

Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Lop...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It controls the symptoms of diarrhea, including travelers' diarrhea in over-the-counter products. Prescription-labeled capsules are also used for chronic diarrhea in adults with in...
  • Take it by mouth, usually after loose stools, following the label chart for your age and weight. Drink lots of clear fluids so you don't get dehydrated. With liquids, shake well an...
  • No. Taking more than directed can cause serious, even fatal, heart rhythm problems. If diarrhea lasts more than 2 days or gets worse, stop and call your doctor.
  • Can I take extra if the diarrhea isn't stopping?
📖 Read our full Loperamide guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.
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
84386-0117-24 You're viewing this Main listing 4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK 2026-06-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense anti diarrheal 2 mg 00113-0224-53 L. 1 tablet $0.130 — Availability likely —
anti diarrheal 2 mg 00113-2224-62 L. 1 tablet $0.130 — Availability likely —
anti diarrheal 2 mg 00904-7725-12 Major 1 tablet $0.130 — Availability likely —
Loperamide Hydrochloride 2 mg 46122-0738-53 Amerisource 12 tablets $0.130 — Availability likely —
leader anti diarrheal 2 mg 70000-0589-01 Cardinal 1 tablet $0.130 — Availability likely —
foster and thrive anti diarrheal 2 mg 70677-1106-01 Strategic 1 tablet $0.130 — Availability likely —
Anti Diarrheal 2 mg 83324-0064-12 Chain 12 tablets $0.130 — Availability likely —
Anti Diarrheal 2 mg 63868-0559-12 CHAIN 12 tablets $0.147 — FDA listed —
injoy diarrhea relief 2 mg 00113-6004-62 L. 1 tablet — — FDA listed —
Anti-Diarrheal 2 mg 00363-0375-02 Walgreen 12 tablets — — FDA listed —
anti diarrheal 2 mg 00363-1010-53 Walgreen 1 tablet — — FDA listed —
Up and Up anti diarrheal 2 mg 11673-0224-02 Target 24 tablets — — Discontinued —
Anti-Diarrheal 2 mg 11822-0375-03 Rite 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 21130-0375-08 Better 24 tablets — — FDA listed —
Loperamide Hydrochloride 2mg 2 mg 25000-0001-83 MARKSANS 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 29485-9286-02 Lil' 25 tablets — — FDA listed —
Anti-Diarrheal 2 mg 30142-0775-02 Kroger 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 35418-0123-12 Zee 12 tablets — — FDA listed —
topcare anti diarrheal 2 mg 36800-0224-53 Topco 1 tablet — — FDA listed —
Anti-Diarrheal 2 mg 37808-0375-08 H 24 tablets — — FDA listed —
Anti Diarrheal 2 mg 37808-0552-23 H 72 tablets — — Discontinued —
Anti-diarrheal 2 mg 37835-0131-01 BI-MART 100 tablets — — FDA listed —
Anti-Diarrheal 2 mg 41163-0375-02 United 12 tablets — — FDA listed —
anti diarrheal 2 mg 41250-0224-53 Meijer 1 tablet — — FDA listed —
CareOne Diarrhea Control 2 mg 41520-0813-53 American 1 tablet — — FDA listed —
anti diarrheal 2 mg 42507-0224-53 HyVee 1 tablet — — FDA listed —
MEDIQUE Diamode 2 mg 47682-0200-33 Unifirst 100 tablets — — Discontinued —
MEDIQUE Diamode 2 mg 47682-0400-46 Unifirst 1 tablet — — FDA listed —
Anti Diarrheal 2 mg 49035-0375-08 Wal-Mart 24 tablets — — FDA listed —
Imodium A-D 2 mg 50580-0317-01 Kenvue 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 50844-0259-02 L.N.K. 12 tablets — — FDA listed —
Anti-diarrheal 2 mg 50844-0375-02 L.N.K. 12 tablets — — FDA listed —
Loperamide HCl 2 mg 50844-0735-02 L.N.K. 12 tablets — — FDA listed —
Good Sense anti diarrheal 2 mg 51655-0663-54 Northwind 15 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 51660-0123-06 Ohm 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 53117-0248-86 First 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 53329-0664-57 Medline 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 53943-0123-12 Discount 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 53943-0375-02 Discount 12 tablets — — FDA listed —
Anti Diarrheal 2 mg 55301-0375-02 ARMY 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 55315-0123-06 Fred's 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 55319-0375-08 Family 24 tablets — — FDA listed —
dg health anti diarrheal 2 mg 55910-0224-23 Dolgencorp, 72 tablets — — Discontinued —
Anti-Diarrheal 2 mg 55910-0375-08 DOLGENCORP, 24 tablets — — FDA listed —
anti diarrheal 2 mg 56062-0224-53 Publix 1 tablet — — FDA listed —
Anti-Diarrheal 2 mg 57896-0381-13 Geri-Care 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0701-01 Aurohealth 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0870-76 Aurohealth 24 tablets — — FDA listed —
anti diarrheal 2 mg 59779-0700-53 CVS 1 tablet — — FDA listed —
anti diarrheal 2 mg 59779-0960-62 CVS 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 63187-0462-12 Proficient 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 63868-0338-12 Chain 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 63941-0123-12 Valu 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 63941-0375-02 Valu 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 66424-0725-24 SDA 24 tablets — — FDA listed —
Anti-Diarrheal, 24/7 Life by 7-Eleven 2 mg 66715-4644-04 Lil' 12 tablets — — FDA listed —
Anti-Diarrheal, Circle K 2 mg 66715-5529-02 Lil' 4 tablets — — FDA listed —
Anti-Diarrheal, Caseys 4good 2 mg 66715-6359-02 Lil' 4 tablets — — FDA listed —
Anti-Diarrheal, CVP HEALTH 2 mg 66715-6559-02 Lil' 4 tablets — — FDA listed —
Lil Drug Store Anti-Diarrheal 2 mg 66715-9859-02 Lil' 2 tablets — — FDA listed —
Anti-Diarrheal 2 mg 67091-0335-18 WinCo 12 tablets — — FDA listed —
anti diarrheal 2 mg 67296-1472-07 Redpharm 24 tablets — — FDA listed —
Handy Solutions Anti-Diarrheal 2 mg 67751-0162-01 Navajo 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 68016-0123-06 Chain 6 tablets — — FDA listed —
Anti-diarrheal 2 mg 68016-0301-06 Chain 6 tablets — — Discontinued —
berkley and jensen anti diarrheal 2 mg 68391-0224-01 BJWC 96 tablets — — Discontinued —
Loperamide Hydrochloride 2 mg 68788-8393-02 Preferred 24 tablets — — FDA listed —
Good Sense anti diarrheal 2 mg 68788-8750-02 Preferred 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 68998-0123-24 Marc 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 69168-0248-86 Allegiant 6 tablets — — FDA listed —
Leader Anti Diarrheal 2 mg 70000-0225-01 Cardinal 1 tablet — — Discontinued —
Good Sense anti diarrheal 2 mg 71205-0079-12 Proficient 1 tablet — — FDA listed —
MEDIQUE Diamode 2 mg 71205-0316-01 Proficient 1 tablet — — FDA listed —
basic care loperamide hydrochloride 2 mg 72288-0224-62 Amazon.com 1 tablet — — FDA listed —
Amazon Basic Care Loperamide Hydrochloride 2 mg 72288-0225-76 Amazon.com 24 tablets — — FDA listed —
WELMATE Anti Diarrheal Loperamide HCl 2 mg 73581-0101-24 YYBA 24 tablets — — FDA listed —
Anti Diarrheal 2 mg 73581-0171-24 Yyba 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 80136-0063-11 Heartland 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 80513-0375-08 Advanced 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 80513-0401-24 Advanced 24 tablets — — FDA listed —
Amazon Basic Care Loperamide Hydrochloride 2 mg 82804-0295-06 Proficient 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mgthis 84386-0117-24 Aurobindo 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 84441-0711-02 IMO-GEN 200 tablets — — FDA listed —
MEDIQUE Diamode 2 mg 85766-0120-01 Sportpharm 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 85766-0154-06 Sportpharm 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 85828-0248-93 Grocery 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 73581-0175-24 YYBA 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 41226-0797-22 Kroger 6 tablets — — 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
Jun 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.

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

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA206548 (ANDA)
Labeler code84386
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio1,456 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 📄 When Using This Product 📄 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 8 words ▾

Use controls symptoms of diarrhea, including Travelers' Diarrhea

⏱️ Dosage and Administration 144 words ▾

Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9 to 11 years (60 to 95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6 to 8 years (48 to 59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours children 2 to 5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

⚠️ Warnings 33 words ▾

Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride Heart alert: Taking more than directed can cause serious heart problems or death

📦 Storage and Handling 36 words ▾

Other information store at 20° to 25°C (68° to 77°F). do not use if carton or blister unit is open or torn Meets USP dissolution test 2 see side panel for lot number and expiration date

🧪 Active Ingredient 12 words ▾

Drug Facts Active ingredient (in each tablet) Loperamide hydrochloride USP 2 mg

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients colloidal silicon dioxide, D & C yellow No. 10 aluminum lake, FD & C blue No. 1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate

🎯 Purpose 2 words ▾

Purpose Anti-diarrheal

📄 Do Not Use 10 words ▾

Do not use if you have bloody or black stool

📄 Ask a Doctor Before Use If 24 words ▾

Ask a doctor before use if you have fever mucus in the stool a history of liver disease a history of abnormal heart rhythm

📄 Ask a Doctor or Pharmacist Before Use If 21 words ▾

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

📄 When Using This Product 17 words ▾

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

📄 Stop Use and Ask a Doctor If 31 words ▾

Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health 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 (1-800-222-1222) right away.

📄 Questions or Comments 21 words ▾

Questions or comments? call 1-855-274-4122 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India

📄 Package Label / Principal Display Panel 52 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets) AUROBINDO NDC 84386-117-24 *Compare to the active ingredient of Imodium ® A-D Loperamide Hydrochloride Tablets USP 2 mg Anti-Diarrheal Controls the symptoms of diarrhea 24 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (2 x 6's Tablets)

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

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 Aurobindo Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aurobindo Pharma Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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.
← 84386-0113-01 · Aurobindo 84386-0119-78 · Aurobindo →
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.