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Omeprazole Magnesium 20 mg Capsule, Delayed Release, 1,500-count — NDC 55111-397-89 (Billing 55111-0397-89)

by Dr. Reddy's Laboratories Limited · 1500 CAPSULE, DELAYED RELEASE in 1 POUCH

This is a package of 1,500 capsules of Omeprazole Magnesium 20 mg Capsule, Delayed Release from Dr. Reddy's Laboratories Limited, marketed since Mar 2010 and currently FDA-listed.

NDC 55111-0397-89
🏷️ FDA NDC (as labeled) 55111-397-89 billing pads the product segment with a zero
This package
Contains1,500-count Pack sizes7 compare ↓
Product page 55111-0397-27 Also comes in: 7 capsules 55111-397-28 7 capsules 55111-397-42 14 capsules 55111-397-27 14 capsules 55111-397-33 14 capsules 55111-397-39 14 capsules 55111-397-52
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) 55111-397-89
Product NDC 55111-397
11-digit billing NDC 55111039789
RxCUI 198051
UNII 426QFE7XLK
Application # ANDA078878
SPL Set ID 0e8fde83-a55c-edaf-3c66-e1fc77d0bc11
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Cytochrome P450 2C19 Inhibitors; Proton Pump Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-03-01
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance OMEPRAZOLE MAGNESIUM

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

GPI-14 49270060106520
GPI class Omeprazole Magnesium
GCN Seq No 066403
GCN 28664
HICL code 011115
Ingredient (HICL) Omeprazole Magnesium
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4J
Therapeutic class — specific (HIC3) Proton-Pump Inhibitors
AHFS code 56:28.36.00
AHFS class Proton-Pump Inhibitors
FDB label name OMEPRAZOLE MAG DR 20.6 MG CAP
FDB brand name Omeprazole Magnesium
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 066403
  • GCN: 28664
  • GPI-14 (Medi-Span): 49270060106520
  • HICL (First Databank): 011115
  • AHFS class code: 56:28.36.00
  • RxCUI (RxNorm): 198051
Why two NDCs? The FDA registers this code as 55111-397-89 — 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 → 55111-0397-89. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors
How it works Proton Pump Inhibitors, Cytochrome P450 2C19 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name OMEPRAZOLE MAG DR 20.6 MG CAP Ingredient Omeprazole Magnesium
📖 What it is MedlinePlus · NLM

Prescription omeprazole is used alone or with other medications to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with G...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It lowers stomach acid. Prescription versions treat ulcers, GERD, erosive esophagitis and H. pylori infection. Over-the-counter versions treat frequent heartburn, which is heartbur...
  • Take it by mouth once a day, before eating. For over-the-counter use, that means the morning, with water, for a 14-day course. Swallow capsules and regular tablets whole. Dissolvin...
  • It is not for immediate relief. The over-the-counter label says full effect can take 1 to 4 days. Some people feel complete relief within 24 hours.
  • The most common are headache, stomach pain, nausea, diarrhea, vomiting and gas. Call your doctor for diarrhea that does not go away, new rash or joint pain, or signs of an allergic...
📖 Read our full Omeprazole guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
9
Nutrient depletion considerations

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

🧪 Full Omeprazole 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: 7 capsules 7 capsules 14 capsules 14 capsules 14 capsules 14 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
55111-0397-27 55111-397-27 Main listing 2 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE $0.3951 / ea $11.06 2010-03-01 — Active
55111-0397-28 55111-397-28 2 CARTON in 1 CARTON / 2 BLISTER PACK in 1 CARTON / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK — — 2010-03-01 — Active
55111-0397-33 55111-397-33 3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE $0.3951 / ea $16.59 2010-03-01 — Active
55111-0397-39 55111-397-39 3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE — — 2015-09-01 — Active
55111-0397-42 55111-397-42 3 CARTON in 1 CARTON / 2 BLISTER PACK in 1 CARTON / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK — — 2010-03-01 — Active
55111-0397-52 55111-397-52 1 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE $0.3951 / ea $5.53 2010-03-01 — Active
55111-0397-89 You're viewing this 1500 CAPSULE, DELAYED RELEASE in 1 POUCH — — — — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 1,500-count package — 1500 capsule, delayed release in 1 pouch.
How does this package differ from NDC 55111-0397-52?
Both are Omeprazole Magnesium 20 mg Capsule, Delayed Release — the drug itself is identical. This page's package is the 1,500-count one, while NDC 55111-0397-52 is the 14 capsules package.
What NDC number is used to bill for this package of Omeprazole Magnesium 20 mg Capsule, Delayed Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Omeprazole 20 mg 16714-0715-01 NorthStar 30 capsules $0.028 AB Discontinued —
Omeprazole 20 mg 60505-0065-00 Apotex 30 capsules $0.028 AB Discontinued —
Omeprazole 20 mg 68084-0128-01 American 1 capsule $0.028 AB Discontinued —
Omeprazole 20 mg 00781-2868-01 Sandoz 100 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 00904-6917-61 Major 1 capsule $0.029 AB Availability likely —
Omeprazole 20 mg 16714-0634-01 NorthStar 30 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 55111-0158-01 Dr. 100 capsules $0.029 — Availability likely —
Omeprazole 20 mg 55111-0644-01 Dr. 100 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 60687-0597-01 American 1 capsule $0.029 AB Availability likely —
Omeprazole 20 mg 68382-0412-01 Zydus 100 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 68462-0396-01 Glenmark 100 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 82009-0022-10 Quallent 1000 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 82009-0183-10 Quallent 1000 capsules $0.029 AB Availability likely —
Omeprazole 20 mg 60505-3952-03 Apotex 30 capsules $0.034 AB Discontinued —
Omeprazole 20 mg 62175-0118-32 Lannett 30 capsules $0.036 AB FDA listed —
Acid Reducer 20 mg 70000-0232-01 LEADER/ 14 capsules $0.395 — Availability likely —
Omeprazole Magnesium 20 mg 83324-0117-14 Chain 14 capsules $0.395 — Availability likely —
Omeprazole 20.6 mg 46122-0686-03 AMERISOURCE 14 capsules $0.408 — Discontinued —
Omeprazole Magnesium 20 mg 00363-0042-01 Walgreens 14 capsules — — FDA listed —
Omeprazole 20 mg 00363-4099-03 Walgreen 14 capsules — — FDA listed —
omeprazole 20 mg 00363-6089-01 Walgreen 14 capsules — — FDA listed —
Omeprazole 20 mg 00363-9980-14 Walgreen 14 capsules — — FDA listed —
Omeprazole 20 mg 00615-8406-05 NCS 15 capsules — AB FDA listed —
Omeprazole 20 mg 00781-2790-01 Sandoz 100 capsules — AB FDA listed —
Omeprazole 20 mg 11673-0948-14 UP 14 capsules — — FDA listed —
omeprazole 20.6 mg 11822-0061-04 Rite 14 capsules — — FDA listed —
Omeprazole Magnesium 20 mg 21130-0398-33 Albertsons 14 capsules — — FDA listed —
omeprazole 20 mg 21130-0528-01 Safeway 14 capsules — — FDA listed —
Omeprazole 20 mg 21130-0783-01 Safeway 14 capsules — — FDA listed —
Omeprazole Magnesium 20 mg 30142-0012-01 The 14 capsules — — FDA listed —
omeprazole 20 mg 31722-0528-01 Camber 100 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 37808-0006-33 HEB 14 capsules — — FDA listed —
Omeprazole 20 mg 42708-0170-14 QPharma 14 capsules — AB FDA listed —
Omeprazole 20 mg 42708-0199-14 QPharma 14 capsules — AB FDA listed —
Omeprazole 20 mg 43063-0743-14 PD-Rx 14 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 43598-0813-14 Dr. 14 capsules — — FDA listed —
Omeprazole Magnesium 20 mg 49035-0397-27 Wal-Mart 14 capsules — — FDA listed —
Omeprazole 20 mg 49999-0265-14 Quality 14 capsules — AB Discontinued —
Omeprazole 20 mg 50090-1157-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-3876-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-5111-00 A-S 90 capsules — AB FDA listed —
Omeprazole 20 mg 50090-5901-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-5902-00 A-S 90 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7018-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7019-00 A-S 90 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7021-00 A-S 1 capsule — AB FDA listed —
Omeprazole 20 mg 50090-7213-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7214-00 A-S 100 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7215-00 A-S 90 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7472-00 A-S 30 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7473-00 A-S 100 capsules — AB FDA listed —
Omeprazole 20 mg 50090-7474-00 A-S 90 capsules — AB FDA listed —
Omeprazole 20 mg 51316-0061-28 CVS 28 capsules — — FDA listed —
omeprazole 20 mg 51316-0271-03 CVS 14 capsules — — FDA listed —
Omeprazole 20 mg 51316-0843-03 CVS 14 capsules — — FDA listed —
Omeprazole 20 mg 51407-0287-01 Golden 100 capsules — AB Discontinued —
Omeprazole 20 mg 51407-0641-00 Golden 1 capsule — AB FDA listed —
Omeprazole 20 mg 51407-0813-01 Golden 100 capsules — AB FDA listed —
Omeprazole 20 mg 51655-0061-25 Northwind 60 capsules — AB FDA listed —
Omeprazole 20 mg 51655-0893-25 Northwind 60 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 53943-0520-14 Discount 14 capsules — — FDA listed —
Omeprazole Magnesium 20 mgthis 55111-0397-89 Dr. 1500 capsules — — FDA listed —
Omeprazole 20 mg 55154-2332-00 Cardinal 1 capsule — AB FDA listed —
Omeprazole 20 mg 57237-0161-01 Rising 100 capsules — AB FDA listed —
omeprazole 20.6 mg 57483-0740-42 INNOVUS 14 capsules — — FDA listed —
Omeprazole Magnesium 20.6 mg 57896-0759-14 Gericare 14 capsules — — FDA listed —
Omeprazole 20 mg 58602-0837-05 Aurohealth 14 capsules — — FDA listed —
Omeprazole 20 mg 59651-0002-01 Aurobindo 100 capsules — — FDA listed —
Omeprazole 20 mg 60760-0747-07 St. 7 capsules — AB FDA listed —
Omeprazole 20 mg 60760-0833-30 St. 30 capsules — AB FDA listed —
Omeprazole 20 mg 60760-0868-07 St. 7 capsules — AB FDA listed —
Omeprazole 20 mg 63187-0070-14 Proficient 14 capsules — AB FDA listed —
Omeprazole 20 mg 63187-0820-06 Proficient 6 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 63868-0177-15 Chain 14 capsules — — FDA listed —
Omeprazole 20 mg 65841-0760-01 Zydus 100 capsules — AB FDA listed —
Omeprazole 20 mg 67046-1509-03 Coupler 30 capsules — AB FDA listed —
Omeprazole 20 mg 67296-1939-03 Redpharm 30 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 68016-0760-14 Chain 14 capsules — — FDA listed —
Omeprazole 20 mg 68071-2243-07 NuCare 7 capsules — AB FDA listed —
Omeprazole 20 mg 68071-2262-03 NuCare 30 capsules — AB FDA listed —
Omeprazole 20 mg 68071-3007-02 NuCare 28 capsules — AB FDA listed —
Omeprazole 20 mg 68071-3733-02 NuCare 20 capsules — AB FDA listed —
Omeprazole 20 mg 68071-4024-03 NuCare 30 capsules — AB FDA listed —
Omeprazole 20 mg 68071-4025-03 NuCare 30 capsules — AB FDA listed —
Omeprazole 20 mg 68788-4104-01 Preferred 100 capsules — AB FDA listed —
Omeprazole 20 mg 68788-6881-01 Preferred 100 capsules — AB FDA listed —
Omeprazole 20 mg 68788-8805-01 Preferred 100 capsules — AB FDA listed —
Omeprazole 20 mg 68788-8864-01 Preferred 100 capsules — AB FDA listed —
Omeprazole Magnesium 20 mg 69842-0027-01 CVS 14 capsules — — FDA listed —
Omeprazole 20 mg 70518-2251-00 REMEDYREPACK 30 capsules — AB Discontinued —
Omeprazole 20 mg 70518-3278-00 REMEDYREPACK 30 capsules — AB Discontinued —
Omeprazole 20 mg 70518-4177-00 REMEDYREPACK 30 capsules — AB FDA listed —
Omeprazole 20 mg 70700-0150-00 Xiromed, 1 capsule — AB FDA listed —
Omeprazole 20 mg 71205-0613-14 Proficient 14 capsules — AB FDA listed —
Omeprazole 20 mg 71205-0907-00 Proficient 100 capsules — AB FDA listed —
Omeprazole 20 mg 71335-0332-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71335-0569-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71335-1636-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71335-1746-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71335-1852-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71335-9609-00 Bryant 7 capsules — AB FDA listed —
Omeprazole 20 mg 71610-0663-30 Aphena 30 capsules — AB FDA listed —
Omeprazole 20 mg 71610-0912-30 Aphena 30 capsules — AB FDA listed —
Omeprazole 20 mg 71610-0942-30 Aphena 30 capsules — AB FDA listed —
Omeprazole 20 mg 71610-0963-60 Aphena 90 capsules — AB FDA listed —
basic care omeprazole 20 mg 72288-0023-03 Amazon.com 42 capsules — — FDA listed —
omeprazole 20 mg 72288-0606-03 Amazon.com 14 capsules — — FDA listed —
Omeprazole 20 mg 72789-0482-14 PD-Rx 14 capsules — AB FDA listed —
Omeprazole 20 mg 76420-0055-03 Asclemed 30 capsules — AB FDA listed —
Omeprazole 20.6 mg 79481-0061-03 Meijer 42 capsules — — FDA listed —
omeprazole 20 mg 79481-0281-00 Meijer, 14 capsules — — FDA listed —
omeprazole 20 mg 79481-3023-01 Meijer, 14 capsules — — FDA listed —
equate omeprazole 20 mg 79903-0112-14 WALMART 14 capsules — — FDA listed —
Omeprazole DR 20 mg 80425-0070-01 Advanced 30 capsules — AB FDA listed —
Omeprazole DR 20 mg 80425-0071-01 Advanced 30 capsules — AB FDA listed —
Omeprazole 20 mg 80425-0415-01 Advanced 30 capsules — AB FDA listed —
Omeprazole 20 mg 80425-0504-01 Advanced 30 capsules — AB FDA listed —
Omeprazole 20 mg 82868-0043-60 Northwind 60 capsules — AB FDA listed —
Omeprazole 20 mg 83209-0150-05 Boswell 5 capsules — AB FDA listed —
Omeprazole 20 mg 85509-1396-01 PHOENIX 120 capsules — AB FDA listed —
Omeprazole 20 mg 85509-1644-01 PHOENIX 120 capsules — AB FDA listed —
Omeprazole 20 mg 73581-0015-03 YYBA 14 capsules — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2010
On the market since
Mar 2010
📍
2026
Currently FDA-listed
16 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 White / Pink
ShapeCapsule
ImprintOMP20
Size22 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.

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

LabelerDr. Reddy's Laboratories Limited
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA078878 (ANDA)
Labeler code55111
First marketedMar 2010
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.

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 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

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

⏱️ Dosage and Administration 166 words ▾

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

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

⚠️ Warnings ~1 min read ▾

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

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

Acid reducers may interact with certain prescription drugs. Stop use and ask doctor if: your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain If pregnant or breast-feeding, ask a health 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 16 words ▾

Active ingredient (in each capsule) *Omeprazole delayed-release capsules 20 mg (equivalent to 20.6 mg omeprazole magnesium)

🧪 Inactive Ingredients 51 words ▾

Inactive ingredients black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

🎯 Purpose 3 words ▾

Purpose Acid reducer

📄 Do Not Use 59 words ▾

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

📄 Ask a Doctor Before Use If 36 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 22 words ▾

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

📄 Stop Use and Ask a Doctor If 45 words ▾

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

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

📄 Questions or Comments 3 words ▾

Questions call 1-888-375-3784

📄 Package Label / Principal Display Panel 80 words ▾

Bottle Label Dr.Reddy's NDC 55111-397-52 Treats Frequent Heartburn! 24 HR Omeprazole Delayed Release- Capsules 20 mg* ACID REDUCER 14 Capsules(Safety Sealed) One 14-Day Course of Treatment May take 1 to 4 days for full effect

Carton Label Dr.Reddy's NDC 55111-397-52 Compare to the active ingredient in Prilosec OTC ® ** Treats Frequent Heartburn! 24 HR Omeprazole Delayed Release- Capsules 20 mg* ACID REDUCER 14 Capsules(Safety Sealed) One 14-Day Course of Treatment May take 1 to 4 days for full effect

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
14 capsules55111-0397-27 8,736 Rx · $104,367
14 capsules55111-0397-33 5,569 Rx · $92,666
14 capsules55111-0397-52 59 Rx · $1,648
7 capsules55111-0397-28 No Medicaid data
14 capsules55111-0397-39 No Medicaid data
7 capsules55111-0397-42 No Medicaid data
1500 capsules this page55111-0397-89 No Medicaid data
Drug total (last 4 qtrs): 14,364 Rx · 743,492 units · $198,681 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Prilosec (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Prilosec. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$832.8K
Claims incl. refills
826
Beneficiaries
380
Spend / beneficiary
$2,191.63
Spend / claim
$1,008.26
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by 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 6 other package presentations of this same product, including 7 capsules (55111-0397-28), 7 capsules (55111-0397-42), 14 capsules (55111-0397-27). 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.
← 55111-0396-08 · Dr.Reddys 55111-0398-01 · 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.