Home › NDC Lookup › Ingredients › Ranitidine › 55111-0131-80
Ranitidine 75 mg Tablet, 80-count — NDC 55111-0131-80 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ranitidine 75 mg Tablet, 80-count — NDC 55111-131-80 (Billing 55111-0131-80)

by Dr. Reddy's Laboratories Limited · 1 BOTTLE in 1 CARTON / 80 TABLET in 1 BOTTLE

This is a package of 80 tablets of Ranitidine 75 mg Tablet from Dr. Reddy's Laboratories Limited, marketed since Mar 2000 and currently FDA-listed.

NDC 55111-0131-80
🏷️ FDA NDC (as labeled) 55111-131-80 billing pads the product segment with a zero
This package
Contains80-count Pack sizes10 compare ↓
Product page 55111-0131-04 Also comes in: 10 tablets 55111-131-79 20 tablets 55111-131-14 30 tablets 55111-131-30 30 tablets 55111-131-81 45 tablets 55111-131-45 60 tablets 55111-131-60 90 tablets 55111-131-90 120 tablets 55111-131-04 160 tablets 55111-131-37
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

NDC database record

One package, one record: these facts belong to NDC 55111-131-80 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55111 labeler · 131 product · 80 package
Package marketed since
Mar 1, 2000
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5511113180 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55111-131-80
Product NDC 55111-131
11-digit billing NDC 55111013180
RxCUI 312773
UNII BK76465IHM
Application # ANDA075294
SPL Set ID 12a38e29-130c-6d41-1753-acccb0b41efe
Established class (EPC) Histamine-2 Receptor Antagonist
Mechanism of action Histamine H2 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-03-01
Route ORAL
Dosage form TABLET
Substance RANITIDINE HYDROCHLORIDE

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

GPI-14 49200020100303
GPI class raNITIdine HCl
GCN Seq No 023441
GCN 10202
HICL code 004520
Ingredient (HICL) Ranitidine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2D
Therapeutic class — specific (HIC3) Histamine H2-Receptor Inhibitors
AHFS code 56:28.12.00
AHFS class Histamine H2-Antagonists
FDB label name RANITIDINE 75 MG TABLET
FDB brand name Ranitidine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 023441
  • GCN: 10202
  • GPI-14 (Medi-Span): 49200020100303
  • HICL (First Databank): 004520
  • AHFS class code: 56:28.12.00
  • RxCUI (RxNorm): 312773
Why two NDCs? The FDA registers this code as 55111-131-80 — 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 → 55111-0131-80. 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 Histamine-2 Receptor Antagonist class.

Pharmacologic class Histamine-2 Receptor Antagonist
Drug family (ATC) H2-receptor antagonists
How it works Histamine H2 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name RANITIDINE 75 MG TABLET Ingredient Ranitidine Hcl
📗 Our plain-language guide HelloPharmacist
  • Ranitidine is used to reduce the amount of acid your stomach makes. Prescription versions treat ulcers in the stomach or small intestine, acid reflux disease (GERD), and acid damag...
  • No, food doesn't significantly affect how ranitidine works, so you can take it with or without a meal. For prescription forms, your doctor will tell you how often to take it — usua...
  • How should I take ranitidine — does it matter if I eat first?
  • Most people do fine on ranitidine. The most common complaints are headache, constipation, diarrhea, nausea, or an upset stomach. Dizziness or trouble sleeping can also happen. Thes...
📖 Read our full Ranitidine guide →
6
Nutrient depletion considerations

Ranitidine may be associated with lower levels of 6 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Ranitidine 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: 10 tablets 20 tablets 30 tablets 30 tablets 45 tablets 60 tablets 90 tablets 120 tablets 160 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55111-0131-04 55111-131-04 Main listing 1 BOTTLE in 1 CARTON / 120 TABLET in 1 BOTTLE 2000-03-01 — Active
55111-0131-14 55111-131-14 2 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK 2000-03-01 — Active
55111-0131-30 55111-131-30 1 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE 2000-03-01 — Active
55111-0131-37 55111-131-37 1 BOTTLE in 1 CARTON / 160 TABLET in 1 BOTTLE 2000-03-01 — Active
55111-0131-45 55111-131-45 1 BOTTLE in 1 CARTON / 45 TABLET in 1 BOTTLE 2000-03-01 — Active
55111-0131-60 55111-131-60 1 BOTTLE in 1 CARTON / 60 TABLET in 1 BOTTLE 2000-03-01 — Active
55111-0131-79 55111-131-79 1 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK 2000-03-01 — Active
55111-0131-80 You're viewing this 1 BOTTLE in 1 CARTON / 80 TABLET in 1 BOTTLE 2000-03-01 — Active
55111-0131-81 55111-131-81 3 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK 2000-03-01 — Active
55111-0131-90 55111-131-90 1 BOTTLE in 1 CARTON / 90 TABLET in 1 BOTTLE 2000-03-01 — Active

Pack size FAQ

What quantity is in this package?
This is a 80-count package — 1 bottle in 1 carton / 80 tablet in 1 bottle.
How does this package differ from NDC 55111-0131-79?
Both are Ranitidine 75 mg Tablet — the drug itself is identical. This page's package is the 80-count one, while NDC 55111-0131-79 is the 10 tablets package.
What NDC number is used to bill for this package of Ranitidine 75 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ranitidine 75 mgthis 55111-0131-80 Dr. 80 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

🏛️
2000
On the market since
Mar 2000
📍
2026
Currently FDA-listed
26 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 Pink
ShapeRound
ImprintP75
Size7 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 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.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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.

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

The official label also statesFD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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 Limited
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA075294 (ANDA)
Labeler code55111
First marketedMar 2000
Product typeHuman Otc Drug
Portfolio200 products on file

More NDCs from Dr. Reddy's Laboratories Limited labeler code 55111

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 📄 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 29 words ▾

Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

⏱️ Dosage and Administration 71 words ▾

Directions adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn can be used up to twice daily (do not take more than 2 tablets in 24 hours) do not chew tablet children under 12 years: ask a doctor

⚠️ Warnings 195 words ▾

Warnings Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have had heartburn over 3 months.

This may be a sign of a more serious condition. 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 frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disease 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 If pregnant or breast-feeding , ask a health 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).

🧪 Active Ingredient 14 words ▾

Active ingredient (in each tablet) Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 mg)

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

🎯 Purpose 3 words ▾

Purpose Acid reducer

📄 Do Not Use 34 words ▾

Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers

📄 Ask a Doctor Before Use If 66 words ▾

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

📄 Stop Use and Ask a Doctor If 23 words ▾

Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days

🤰 If Pregnant or Breast-Feeding 11 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 right away (1-800-222-1222).

📄 Questions or Comments 21 words ▾

Questions? call 1-888-375-3784 Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information .

📄 Package Label / Principal Display Panel 16 words ▾

Ranitidine Tablets USP, 75 mg - container label

Ranitidine Tablets USP, 75 mg - Container CartonLabel

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

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 RANITIDINE — the ingredient across all brands.

Top reported reactions

Breast Cancer29,413
Prostate Cancer26,446
Colorectal Cancer20,720
Bladder Cancer19,207
Renal Cancer19,035
Oesophageal Carcinoma11,066
Hepatic Cancer8,834

Age at onset

Neonate136
Infant97
Child265
Adolescent197
Adult7,430
Elderly3,424

Reporter sex

230,801 reports
Male · 48%
Female · 52%
Unknown · 0%

Serious outcomes

Death17,886
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 116,080 510
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.

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 Limited. 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 9 other package presentations of this same product, including 10 tablets (55111-0131-79), 20 tablets (55111-0131-14), 30 tablets (55111-0131-30). 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?
Dr. Reddy's Laboratories 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.
← 55111-0130-01 · Dr. 55111-0133-01 · Dr. →
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.