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Omeprazole 40 mg Capsule, Delayed Release Pellets, 50,000-count — NDC 73476-644-00 (Billing 73476-0644-00)

by Towa Pharmaceutical Europe, S.L. · 50000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM

This is a package of 50,000 capsules of Omeprazole 40 mg Capsule, Delayed Release Pellets from Towa Pharmaceutical Europe, S.L., marketed since Jul 2017 and currently FDA-listed. It is this product's only package size.

NDC 73476-0644-00
🏷️ FDA NDC (as labeled) 73476-644-00 billing pads the product segment with a zero
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 73476-644-00 alone.

Record
FDA NDC Directory package listing · Drug for further processing
Code segments
73476 labeler · 644 product · 00 package
Package marketed since
Dec 27, 2019
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7347664400 0
FDA record last changed
Jul 24, 2026
⚠️
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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73476-644-00
Product NDC 73476-644
11-digit billing NDC 73476064400
SPL Set ID 1e5894b5-d99c-4f20-8fec-ad447c40efe4
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-07-03
Dosage form CAPSULE, DELAYED RELEASE PELLETS
Substance OMEPRAZOLE
Why two NDCs? The FDA registers this code as 73476-644-00 — 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 → 73476-0644-00. 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.

Clinical

📗 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 →
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.
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
73476-0644-00 You're viewing this Main listing 50000 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM — — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Omeprazole 40 mg 60505-0146-00 Apotex 30 capsules $0.049 AB Discontinued —
Omeprazole 40 mg 68382-0500-01 Zydus 100 capsules $0.050 AB Availability likely —
Omeprazole 40 mg 16714-0123-01 NorthStar 30 capsules $0.050 AB Availability likely —
Omeprazole 40 mg 55111-0159-01 Dr. 100 capsules $0.050 AB Availability likely —
Omeprazole 40 mg 60687-0608-01 American 1 capsule $0.050 AB Availability likely —
Omeprazole 40 mg 55111-0645-01 Dr. 100 capsules $0.050 AB Availability likely —
Omeprazole 40 mg 68462-0397-01 Glenmark 100 capsules $0.050 AB Availability likely —
Omeprazole 40 mg 50268-0657-15 AvPAK 1 capsule $0.050 AB Availability likely —
Omeprazole 40 mg 82009-0023-05 Quallent 500 capsules $0.050 AB Availability likely —
Omeprazole 40 mg 00781-2234-01 Sandoz 100 capsules $0.051 AB Availability likely —
Omeprazole 40 mg 62175-0136-32 Lannett 30 capsules $0.053 AB FDA listed —
Omeprazole 40 mg 43353-0829-60 Aphena 90 capsules — AB FDA listed —
Omeprazole 40 mg 71205-0157-30 Proficient 30 capsules — AB FDA listed —
Omeprazole 40 mg 71610-0248-60 Aphena 90 capsules — AB FDA listed —
Omeprazole 40 mg 50090-6720-00 A-S 30 capsules — AB FDA listed —
Omeprazole 40 mg 50090-6721-00 A-S 90 capsules — AB FDA listed —
Omeprazole 40 mg 71335-9744-01 Bryant 60 capsules — AB FDA listed —
Omeprazole 40 mg 72789-0155-90 PD-Rx 90 capsules — AB FDA listed —
Omeprazole 40 mg 72789-0257-90 PD-Rx 90 capsules — AB FDA listed —
Omeprazole DR 40 mg 80425-0169-01 Advanced 30 capsules — AB FDA listed —
Omeprazole 40 mg 00615-8079-05 NCS 15 capsules — AB FDA listed —
Omeprazole 40 mg 50090-7366-00 A-S 30 capsules — AB FDA listed —
Omeprazole 40 mg 51407-0943-00 Golden 1 capsule — AB FDA listed —
Omeprazole 40 mg 59651-0003-01 Aurobindo 100 capsules — — FDA listed —
Omeprazole 40 mg 63187-0170-30 Proficient 30 capsules — AB FDA listed —
Omeprazole 40 mg 68071-4906-09 NuCare 90 capsules — AB FDA listed —
Omeprazole 40 mg 68788-6995-01 Preferred 100 capsules — AB FDA listed —
Omeprazole 40 mg 71610-0280-60 Aphena 90 capsules — AB FDA listed —
Omeprazole 40 mg 71610-0880-00 Aphena 1000 capsules — AB FDA listed —
Omeprazole 40 mg 68071-2199-04 NuCarePharmaceuticals, 14 capsules — AB FDA listed —
Omeprazole 40 mg 68071-2741-03 NuCare 30 capsules — AB FDA listed —
Omeprazole 40 mg 68788-8771-01 Preferred 100 capsules — AB FDA listed —
Omeprazole 40 mgthis 73476-0644-00 Towa 50000 capsules — — FDA listed —
Omeprazole 40 mg 50090-2769-00 A-S 30 capsules — AB FDA listed —
Omeprazole 40 mg 50090-7367-00 A-S 90 capsules — AB FDA listed —
Omeprazole 40 mg 60760-0841-30 ST. 30 capsules — AB FDA listed —
Omeprazole 40 mg 70518-0199-00 REMEDYREPACK 90 capsules — AB FDA listed —
Omeprazole 40 mg 71335-0299-01 Bryant 60 capsules — AB FDA listed —
Omeprazole 40 mg 71335-1851-01 Bryant 60 capsules — AB FDA listed —
Omeprazole 40 mg 71610-0875-53 Aphena 60 capsules — AB FDA listed —
Omeprazole DR 40 mg 80425-0109-01 Advanced 30 capsules — AB FDA listed —
Omeprazole 40 mg 51655-0452-25 Northwind 60 capsules — AB FDA listed —
Omeprazole 40 mg 63187-0828-14 Proficient 14 capsules — AB FDA listed —
Omeprazole 40 mg 76420-0879-00 Asclemed 1000 capsules — AB FDA listed —
Omeprazole 40 mg 42708-0159-14 QPharma, 14 capsules — AB FDA listed —
Omeprazole 40 mg 50090-5501-00 A-S 90 capsules — AB FDA listed —
Omeprazole 40 mg 71335-1395-01 Bryant 60 capsules — AB FDA listed —
Omeprazole 40 mg 71335-1532-01 Bryant 60 capsules — AB FDA listed —
Omeprazole 40 mg 71610-0688-30 Aphena 30 capsules — AB FDA listed —
Omeprazole 40 mg 51407-0664-00 Golden 50000 capsules — AB Discontinued —
Omeprazole 40 mg 71610-0876-53 Aphena 60 capsules — AB FDA listed —
Omeprazole 40 mg 72162-2388-00 Bryant 1000 capsules — AB FDA listed —
Omeprazole 40 mg 82868-0080-60 Northwind 60 capsules — AB FDA listed —
Omeprazole 40 mg 51407-0814-01 Golden 100 capsules — AB FDA listed —
Omeprazole 40 mg 65841-0761-01 Zydus 100 capsules — AB FDA listed —
Omeprazole 40 mg 57237-0162-01 Rising 100 capsules — AB FDA listed —
Omeprazole 40 mg 70700-0151-00 Xiromed, 1 capsule — AB FDA listed —
Omeprazole 40 mg 85534-0037-00 HAWAII 30 capsules — AB FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2017
On the market since
Jul 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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

LabelerTowa Pharmaceutical Europe, S.L.
Labeler code73476
First marketedJul 2017
Product typeDrug For Further Processing
Portfolio6 products on file

More NDCs from Towa Pharmaceutical Europe, S.L. labeler code 73476

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.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

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

Medicare Part D (outpatient prescription) spending for Omeprazole (matched by generic name) — 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.

About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Towa Pharmaceutical Europe, S.L. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 Towa Pharmaceutical Europe, S.L.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Towa Pharmaceutical Europe, S.L. 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.
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.
← 73476-0643-00 · Towa 73476-0746-00 · Towa →
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.