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Ranitidine 150 mg Tablet, Coated — NDC 55111-0404-38 package photo

Ranitidine 150 mg Tablet, Coated

by Dr. Reddy's Laboratories Limited · 4 BLISTER PACK in 1 CARTON (55111-404-38) / 8 TABLET, COATED in 1 BLISTER PACK
NDC 55111-0404-38
🏷️ FDA NDC (as labeled) 55111-404-38 billing pads the product segment with a zero
This package
Contains8 tablet, coated in 1 blister pack Pack sizes14 compare ↓
Also priced by: Part D plans $4.42/unit — full pricing hub ↓
Also comes in: 8 tablets 55111-0404-17 8 tablets 55111-0404-24 24 tablets 55111-0404-34 32 tablets 55111-0404-32 36 tablets 55111-0404-36 40 tablets 55111-0404-40 50 tablets 55111-0404-50 65 tablets 55111-0404-55 65 tablets 55111-0404-61 95 tablets 55111-0404-62 95 tablets 55111-0404-90 200 tablets 55111-0404-02 220 tablets 55111-0404-65
OTC Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 55111-404-38
Product NDC 55111-404
11-digit billing NDC 55111040438
RxCUI 198191
UNII BK76465IHM
Application # ANDA078192
SPL Set ID 00df8a42-296f-80dd-98af-ee8b30eb38cc
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 2009-12-02
Route ORAL
Dosage form TABLET, COATED
Substance RANITIDINE HYDROCHLORIDE
GPI-14 49200020100305
GPI class raNITIdine HCl
GCN Seq No 011673
GCN 10200
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 150 MG TABLET
FDB brand name Ranitidine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 55111-404-38 — 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 → 55111-0404-38. 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.

🏭 Manufacturer & labeler

LabelerDr. Reddy's Laboratories Limited
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA078192 (ANDA)
Labeler code55111
First marketedDec 2009
Product typeHuman Otc Drug
Portfolio200 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name RANITIDINE 150 MG TABLET Ingredient Ranitidine Hcl
📗 Our plain-language guide HelloPharmacist
  • Ranitidine works by turning down your stomach's acid production. Less acid means conditions like ulcers, acid reflux (GERD), and an inflamed esophagus can heal — and it also helps...
  • What exactly is ranitidine supposed to do for me?
  • You can take ranitidine with or without food — eating doesn't significantly affect how well your body absorbs it. For prescription use, just follow the schedule your doctor gave yo...
  • Can I take this with food, or does it have to be on an empty stomach?
📖 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.

💊 What it looks like

Color Pink
ShapeRound
ImprintR150
Size9 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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.

7 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.

💲 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 · Q2 2026 $4.42 $141.58 / 32 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ranitidine 150 mg 62207-0773-36 Granules 50000 tablets — — FDA listed —
Ranitidine 150 mgthis 55111-0404-38 Dr. 8 tablets — — FDA listed —
Ranitidine 150 mg 53746-0253-01 Amneal 100 tablets — — FDA listed —
Ranitidine cool mint 150 mg 62207-0774-36 Granules 50000 tablets — — FDA listed —
Ranitidine 150 mg 64980-0636-03 Rising 30 tablets — AB 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

🏛️
2009
On the market since
Dec 2009
📍
2026
Currently FDA-listed
17 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55111-0404-02 1 BOTTLE in 1 CARTON (55111-404-02) / 200 TABLET, COATED in 1 BOTTLE 2009-12-02 Active
55111-0404-17 1 BLISTER PACK in 1 CARTON (55111-404-17) / 8 TABLET, COATED in 1 BLISTER PACK 2009-12-02 Active
55111-0404-24 3 BLISTER PACK in 1 CARTON (55111-404-24) / 8 TABLET, COATED in 1 BLISTER PACK 2009-12-02 Active
55111-0404-32 1 BOTTLE in 1 CARTON (55111-404-32) / 32 TABLET, COATED in 1 BOTTLE 2009-12-02 Active
55111-0404-34 1 BOTTLE in 1 CARTON (55111-404-34) / 24 TABLET, COATED in 1 BOTTLE 2009-12-02 Active
55111-0404-36 1 BOTTLE in 1 CARTON (55111-404-36) / 36 TABLET, COATED in 1 BOTTLE 2009-12-02 Active
55111-0404-38 You're viewing this 4 BLISTER PACK in 1 CARTON (55111-404-38) / 8 TABLET, COATED in 1 BLISTER PACK 2009-12-02 Active
55111-0404-40 1 BOTTLE in 1 BOTTLE (55111-404-40) / 40 TABLET, COATED in 1 BOTTLE 2009-12-02 Active
55111-0404-50 1 BOTTLE in 1 CARTON (55111-404-50) / 50 TABLET, COATED in 1 BOTTLE 2009-12-02 Active
55111-0404-55 2 BOTTLE in 1 CARTON (55111-404-55) / 65 TABLET, COATED in 1 BOTTLE 2010-01-05 Active
55111-0404-61 1 BOTTLE in 1 CARTON (55111-404-61) / 65 TABLET, COATED in 1 BOTTLE 2009-12-02 Active
55111-0404-62 1 BOTTLE in 1 CARTON (55111-404-62) / 95 TABLET, COATED in 1 BOTTLE 2009-12-02 Active
55111-0404-65 1 BOTTLE in 1 CARTON (55111-404-65) / 220 TABLET, COATED in 1 BOTTLE 2009-12-02 Active
55111-0404-90 2 BOTTLE in 1 CARTON (55111-404-90) / 95 TABLET, COATED in 1 BOTTLE 2009-12-02 Active

Pack size FAQ

What quantity is in NDC 55111-0404-38?
NDC 55111-0404-38 is listed by the FDA — 4 blister pack in 1 carton / 8 tablet, coated in 1 blister pack.
What NDC number is used to bill for this package of Ranitidine 150 mg Tablet, Coated?
Bill NDC 55111-0404-38 — the 11-digit billing format is 55111040438. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 55111-404-38, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55111-0404-38, written without dashes as 55111040438. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 55111-0404-38, the first segment (55111) is the labeler code FDA assigned to Dr. Reddy's Laboratories Limited; the middle segment (0404) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (38) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by 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 13 other package presentations of this same product, including 8 tablets (55111-0404-17), 8 tablets (55111-0404-24), 24 tablets (55111-0404-34). 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.

📄 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
🎯 Indications and Usage 29 words ▾

Use(s) 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 67 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) children under 12 years: ask a doctor

⚠️ Warnings 192 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 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 150 mg (as ranitidine hydrochloride USP, 168 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55111-0399-01 · Dr. 55111-0419-05 · 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.