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OMEPRAZOLE 20.6 mg Capsule, Delayed Release

by AMERISOURCE BERGEN · 2 BOTTLE in 1 BLISTER PACK (46122-686-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46122-686-74)
NDC 46122-0686-03
🏷️ FDA NDC (as labeled) 46122-686-03 billing pads the product segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

⚠️
Other active recalls for Omeprazole (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 30, 2025 — Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0525-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Apr 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 46122-686-03
Product NDC 46122-686
11-digit billing NDC 46122068603
NCPDP billing unit EA — each (per item)
RxCUI 198051
UNII 426QFE7XLK
Application # ANDA210593
SPL Set ID 47dce86f-d184-44cf-8ee3-18dad7f401b8
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 Discontinued
FDA listing status Discontinued by firm (certified through Apr 2024)
Marketing start 2021-03-31
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance OMEPRAZOLE MAGNESIUM
GPI-14 49270060106520
GPI class GNP Omeprazole
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 GNP OMEPRAZOLE MAG DR 20 MG CP
FDB brand name Omeprazole Magnesium
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 46122-686-03 — 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 → 46122-0686-03. 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.

🏭 Manufacturer & labeler

LabelerAMERISOURCE BERGEN
Application holderSUN PHARMA INDUSTRIES LTD
FDA applicationANDA210593 (ANDA)
Labeler code46122
First marketedMar 2021
Product typeHuman Otc Drug
Portfolio206 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 GNP OMEPRAZOLE MAG DR 20 MG CP 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
  • Omeprazole turns down your stomach's acid production by blocking the pump that makes acid in the first place. Depending on why you're taking it, that can mean relief from heartburn...
  • What exactly is omeprazole supposed to do for me?
  • Take it about 30 minutes before a meal, ideally before breakfast. Taking it before eating gives it the best chance to be absorbed and ready to work when your stomach starts produci...
  • When should I take it — before or after eating?
📖 Read our full Omeprazole guide →
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.

🧪 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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.408 $11.43 / 28 capsules
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 $0.2027 $5.68 / 28 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.408 $0.311
▲ Up 29% over the last 24 months.
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
Omeprazole 20 mg 00904-6917-61 Major 1 capsule $0.028 AB Availability likely save 93%
Omeprazole 20 mg 16714-0634-01 NorthStar 30 capsules $0.028 AB Availability likely save 93%
Omeprazole 20 mg 16714-0715-01 NorthStar 30 capsules $0.028 AB Discontinued save 93%
Omeprazole 20 mg 55111-0158-01 Dr. 100 capsules $0.028 — Availability likely save 93%
Omeprazole 20 mg 55111-0644-01 Dr. 100 capsules $0.028 AB Availability likely save 93%
Omeprazole 20 mg 60505-0065-00 Apotex 30 capsules $0.028 AB Discontinued save 93%
Omeprazole 20 mg 60687-0597-01 American 1 capsule $0.028 AB Availability likely save 93%
Omeprazole 20 mg 68084-0128-01 American 1 capsule $0.028 AB Discontinued save 93%
Omeprazole 20 mg 68382-0412-01 Zydus 100 capsules $0.028 AB Availability likely save 93%
Omeprazole 20 mg 68462-0396-01 Glenmark 100 capsules $0.028 AB Availability likely save 93%
Omeprazole 20 mg 82009-0022-10 Quallent 1000 capsules $0.028 AB Availability likely save 93%
Omeprazole 20 mg 82009-0183-10 Quallent 1000 capsules $0.028 AB Availability likely save 93%
Omeprazole 20 mg 00781-2868-01 Sandoz 100 capsules $0.029 AB Availability likely save 93%
Omeprazole 20 mg 60505-3952-03 Apotex 30 capsules $0.034 AB Discontinued save 92%
Omeprazole 20 mg 62175-0118-32 Lannett 30 capsules $0.036 AB FDA listed save 91%
Omeprazole 20.6 mgthis 46122-0686-03 AMERISOURCE 14 capsules $0.408 — Discontinued —
Omeprazole Magnesium 20 mg 55111-0397-27 Dr. 14 capsules $0.408 — Availability likely —
Acid Reducer 20 mg 70000-0232-01 LEADER/ 14 capsules $0.408 — Availability likely —
Omeprazole Magnesium 20 mg 83324-0117-14 Chain 14 capsules $0.408 — Availability likely —
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 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 —
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
Mar 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.

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

Medicare Part D (outpatient prescription) spending for Omeprazole — the program that covers self-administered drugs. 14 manufacturers.
⚠️ 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 Omeprazole. 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
$75.01M
Claims incl. refills
7.1M
Beneficiaries
5.3M
Spend / beneficiary
$14.18
Spend / claim
$10.59
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.

🔬 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 Omeprazole — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease36,807
Nausea27,095
Fatigue26,259
Diarrhoea25,668
Acute Kidney Injury23,964
Dyspnoea21,145
Pain20,498

Age at onset

Neonate292
Infant271
Child706
Adolescent877
Adult32,838
Elderly30,558

Reporter sex

448,293 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization150,621
Death39,276
Life-threatening19,121
Disabling14,768
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 45,465 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
46122-0686-03 You're viewing this 2 BOTTLE in 1 BLISTER PACK (46122-686-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46122-686-74) 2021-03-31 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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) ✓ Available
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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 46122-686-03, 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: 46122-0686-03, written without dashes as 46122068603. 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 46122-0686-03, the first segment (46122) is the labeler code FDA assigned to AMERISOURCE BERGEN; the middle segment (0686) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
AMERISOURCE BERGEN 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 ▾

Uses 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 181 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. Other information read the directions and warnings before use keep the carton. It contains important information.

Store at 20-25°C (68-77°F). [See USP controlled room temperature]. Protect from moisture

⚠️ Warnings 206 words ▾

Warnings Allergy alert Do not use if you are allergic to omeprazole 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 chest 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 a 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 17 words ▾

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

🧪 Inactive Ingredients 74 words ▾

Inactive Ingredients FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate Questions? Call toll-free Monday to Friday 8:30 am to 5 pm EST at 1800-406-7984 . Distributed By: AmerisourceBergen 1 West First Avenue Conshohocken, PA 19428

🎯 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 ↗
← 46122-0685-26 · Amerisource 46122-0688-78 · AmerisourceBergen →
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.