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Loperamide Hydrochloride 2 mg Capsule, Liquid Filled — NDC 43598-0770-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Loperamide Hydrochloride 2 mg Capsule, Liquid Filled — NDC 43598-770-24 (Billing 43598-0770-24)

by Dr. Reddy's Laboratories Inc. · 2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This is a package of Loperamide Hydrochloride 2 mg Capsule, Liquid Filled from Dr. Reddy's Laboratories Inc., marketed since Oct 2021 and currently FDA-listed. It is this product's only package size.

NDC 43598-0770-24
🏷️ FDA NDC (as labeled) 43598-770-24 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 43598-770-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
43598 labeler · 770 product · 24 package
Package marketed since
Aug 1, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4359877024 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43598-770-24
Product NDC 43598-770
11-digit billing NDC 43598077024
RxCUI 978006
UNII 77TI35393C
Application # ANDA213070
SPL Set ID 6fe91ddc-06b6-3a51-2b48-f6f11361ab73
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 2021-10-22
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance LOPERAMIDE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 978006
Why two NDCs? The FDA registers this code as 43598-770-24 — 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 → 43598-0770-24. 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 mLPer 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 $0.2376 —
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
43598-0770-24 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2023-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Loperamide Hydrochloride 2 mg 00093-0311-01 Teva 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 00378-2100-01 Mylan 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 00904-7472-61 Major 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 42799-0605-01 Edenbridge 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 50268-0482-15 AvPAK 50 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 51079-0690-20 Mylan 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 59651-0691-01 Aurobindo 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 60687-0229-01 American 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 69452-0271-20 Bionpharma 100 capsules $0.055 AB Availability likely —
Loperamide hydrochloride 2 mg 72578-0138-01 Viona 100 capsules $0.055 AB Availability likely —
Loperamide Hydrochloride 2 mg 72603-0328-01 NorthStar 100 capsules $0.055 AB Availability likely —
Anti-Diarrheal 2 mg 46122-0581-62 AMERISOURCE 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 70000-0461-01 CARDINAL 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 70677-1062-01 STRATEGIC 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 83324-0208-12 CHAIN 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 83324-0209-24 CHAIN 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 63868-0876-12 CHAIN 12 capsules $0.140 — FDA listed —
Anti-Diarrheal 2 mg 62011-0390-01 Strategic 12 capsules $0.150 — FDA listed —
Anti-Diarrheal 2 mg 00363-1176-08 WALGREENS 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 00615-8497-39 NCS 30 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 11673-0177-12 TARGET 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 11822-7834-02 Rite 12 capsules — — FDA listed —
anti-diarrheal 2 mg 21130-0835-12 Albertsons 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 30142-0159-08 KROGER 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 36800-0208-12 TOP 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 37808-0988-12 HEB 12 capsules — — FDA listed —
anti-diarrheal 2 mg 41250-0210-08 MEIJER 12 capsules — — FDA listed —
First Aid Direct Anti-Diarrheal 2 mg 42961-0103-02 Cintas 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 43063-0020-12 PD-Rx 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mgthis 43598-0770-24 Dr. 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 48433-0063-20 Safecor 100 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 49035-0483-12 Wal-Mart 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 50090-0460-00 A-S 15 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 50090-7398-00 A-S 15 capsules — AB FDA listed —
Imodium A-D 2 mg 50580-0367-01 Kenvue 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 51407-0999-01 Golden 100 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 53943-0176-12 DISCOUNT 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 55154-4699-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 55154-5585-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 55289-0315-06 PD-Rx 6 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 55910-0176-08 DOLGENCORP, 12 capsules — — FDA listed —
anti-diarrheal 2 mg 56062-0680-12 PUBLIX 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0727-74 Aurohealth 6 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 60468-0005-01 allphamed 100 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 63629-8747-01 Bryant 100 capsules — AB FDA listed —
anti-diarrheal 2 mg 63941-0684-12 VALU 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 66267-0132-12 NuCare 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 67046-1676-03 Coupler 30 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 67296-2172-01 Redpharm 15 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 68016-0058-12 Premier 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 68071-2257-06 NuCare 6 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 68071-2700-01 NuCare 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 68071-3618-01 NuCare 12 capsules — AB FDA listed —
anti-diarrheal 2 mg 69452-0176-12 Bionpharma 24 capsules — — FDA listed —
anti-diarrheal 2 mg 69452-0266-12 Bionpharma 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 69842-0061-12 CVS 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 70518-4283-00 REMEDYREPACK 30 capsules — AB FDA listed —
Loperamide hydrochloride 2 mg 70771-1769-01 Zydus 100 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-1921-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2061-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2111-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2487-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2571-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0648-53 Aphena 60 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0781-53 Aphena 60 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0950-30 Aphena 30 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0973-53 Aphena 60 capsules — AB FDA listed —
anti-diarrheal 2 mg 72288-0313-12 Amazon.com 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 72888-0130-00 Advagen 1000 capsules — AB FDA listed —
WELMATE Anti Diarrheal Loperamide HCl Softgels 2 mg 73581-0102-24 YYBA 24 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 75907-0097-12 Dr. 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 80136-0851-42 Northeast 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 55154-0277-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 59556-0959-05 Strides 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 73581-0177-02 YYBA 12 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
Oct 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.

What it looks like

Color Blue
ShapeOval
ImprintL2
Size10 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.

🧪 Avoiding an ingredient? See Loperamide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII G7515SW10N
    A waxy liquid derived from vegetable oil and fatty acids. It works as an emulsifier and solubilizer to help blend oil and water-based ingredients together and improve how the medicine dissolves and is absorbed in the body.
  • UNII 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesbutylated hydroxyanisole, FD&C Blue #1, gelatin, glycerol, glyceryl mono caprylo caprate, polyoxyl 40 hydrogenated castor oil, purified water, printing ink white-edible oil – dewaxed bleached shellac resins, propylene glycol, sodium lauryl sulphate, titanium dioxide.                         

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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.

Manufacturer & labeler

LabelerDr. Reddy's Laboratories Inc.
Application holderONESOURCE SOFTGELS PTE LTD
FDA applicationANDA213070 (ANDA)
Labeler code43598
First marketedOct 2021
Product typeHuman Otc Drug
Portfolio160 products on file

More NDCs from Dr. Reddy's Laboratories Inc. labeler code 43598

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 🧪 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Use controls symptoms of diarrhea, including Travelers' Diarrhea

⏱️ Dosage and Administration 53 words ▾

Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea. not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

⚠️ Warnings 33 words ▾

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

🧪 Active Ingredient 10 words ▾

Active Ingredient (in each capsule) Loperamide Hydrochloride USP, 2 mg

🧪 Inactive Ingredients 36 words ▾

Inactive ingredients butylated hydroxyanisole, FD&C Blue #1, gelatin, glycerol, glyceryl mono caprylo caprate, polyoxyl 40 hydrogenated castor oil, purified water, printing ink white-edible oil – dewaxed bleached shellac resins, propylene glycol, sodium lauryl sulphate, titanium dioxide.

🎯 Purpose 2 words ▾

Purpose Anti-diarrheal

📄 Do Not Use 17 words ▾

Do not use if you have bloody or black stool in children under 12 years of age

📄 Ask a Doctor Before Use If 23 words ▾

Ask a doctor before use if you have fever mucus in 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 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Other Information 36 words ▾

Other information store at 20°-25°C (68°-77°F). Protect from Light. avoid excessive heat above 40°C (104°F) do not use if carton or blister unit is open or torn see side panel for lot number and expiration date

📄 Questions or Comments 76 words ▾

Questions or comments? Questions or Comments? call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784 Distributed by: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in india *All trademarks are property of their respective owners.

This product is not affiliated with the makers/owners of Imodium ® A-D THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION .

📄 Package Label / Principal Display Panel 47 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL ** COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ® A-D Loperamide Hydrochloride Capsules USP, 2 mg Anti-Diarrheal Controls the symptoms of diarrhea Suitable for adults and children 12 years and over 24 Softgels* * each Liquid-filled capsule contains 2 mg Loperamide Hydrochloride, USP

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 ✓ 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 — 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 Dr. Reddy's Laboratories Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Dr. Reddy's Laboratories 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 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.
← 43598-0768-23 · Dr. 43598-0771-11 · Dr.Reddy's →
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.