NDC 65628-0070-05 — Omeprazole Kit

🆔 Identity & classification

FDA NDC (as labeled) 65628-070-05

Product NDC 65628-070

11-digit billing NDC 65628007005

SPL Set ID 46403869-59d4-cc61-e063-6294a90aff09

DEA schedule Non-controlled

Marketing category BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Marketing status Discontinued

FDA listing status Listed (active directory)

Marketing start 2011-12-15

Marketing end 2026-08-20

Dosage form KIT

GPI-14 49270060001820

GPI class First-Omeprazole

GCN Seq No 068329

GCN 31092

HICL code 004673

Ingredient (HICL) Omeprazole

HIC1 code U

Therapeutic class — broad (HIC1) Miscell. Drugs/ Pharmaceutical Adjuvants

HIC2 code U8

Therapeutic class — intermediate (HIC2) Ingredient/Substance Free

HIC3 code U8B

Therapeutic class — specific (HIC3) Compounding Kit

AHFS code 56:28.36.00

AHFS class Proton-Pump Inhibitors

FDB label name FIRST-OMEPRAZOLE 2 MG/ML SUSP

FDB brand name First-Omeprazole

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 65628-070-05 — 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 → 65628-0070-05. 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.

🏭 Manufacturer & labeler

LabelerAzurity Pharmaceuticals, Inc.

Labeler code65628

First marketedDec 2011

Product typeBulk Ingredient

Portfolio57 products on file

🔎 All NDCs from Azurity Pharmaceuticals, Inc.

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 FIRST-OMEPRAZOLE 2 MG/ML SUSP Ingredient Omeprazole

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Omeprazole — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Omeprazole (174 interactions) — ranked by severity →

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.

CALCIUM Insignificant Depletion FOLIC ACID Insignificant Depletion IRON Insignificant Depletion MAGNESIUM Major Depletion ZINC Insignificant Depletion +4 more

🧪 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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$0.9054	—
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Omeprazolethis 65628-0070-05	Azurity	1 kit	—	—	Discontinued	—

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

🏛️

2011

On the market since

Dec 2011

📍

2026

Currently FDA-listed

15 years listed

🔒

·

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 65628-0070-05, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q1 2026 · 5 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

221

Units reimbursed last 4 qtrs

36.8K

Gross reimbursed last 4 qtrs

$33.3K

Avg / prescription

$150.68

Avg / unit

$0.9054

Latest quarter Q1 2026

0Rx

Fee-for-service vs managed care ⓘ

67% FFS 33% MCO

Fee-for-service · 148 Rx Managed care · 73 Rx

State Medicaid map

Units reimbursed · per 100k residents

32.0330

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Tennessee 330 /100k

2 Arizona 74.7 /100k

3 Georgia 44.9 /100k

4 Virginia 32.0 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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.

1 kit65628-0070-03 407 Rx · $62,704

1 kit this page65628-0070-05 221 Rx · $33,301

1 kit65628-0070-10 102 Rx · $16,786

Drug total (last 4 qtrs): 730 Rx · 117,030 units · $112,792 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 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.

🔬 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

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

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 NDC	Description	Marketing start	Status
65628-0070-05 You're viewing this	1 KIT in 1 CONTAINER (65628-070-05) * .3 g in 1 BOTTLE, PLASTIC * 150 mL in 1 BOTTLE, PLASTIC	—	Active
65628-0070-10	1 KIT in 1 CONTAINER (65628-070-10) * 300 mL in 1 BOTTLE, PLASTIC * .6 g in 1 BOTTLE, PLASTIC	—	Active
65628-0070-03	1 KIT in 1 CONTAINER (65628-070-03) * .18 g in 1 BOTTLE, PLASTIC * 90 mL in 1 BOTTLE, PLASTIC	—	Active

This pack accounts for about 30% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 65628-0070-05?

NDC 65628-0070-05 is listed by the FDA — 1 kit in 1 container * .3 g in 1 bottle, plastic * 150 ml in 1 bottle, plastic.

What NDC number is used to bill for this package of Omeprazole Kit?

Bill NDC 65628-0070-05 — the 11-digit billing format is 65628007005. 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

Bulk ingredient (not a finished retail product) Kit / multi-component package No longer marketed (per FDA listing data)

This is a bulk ingredient listing — not a retail prescription package

Omeprazole KIT is listed with FDA as a bulk ingredient (a drug substance supplied for further manufacturing or licensed pharmacy compounding). It is not a finished product a patient would receive at a retail pharmacy, so consumer-style information — a patient label, retail pricing, package photos — generally does not exist for this NDC. The listing identifies the substance and package for supply-chain and regulatory purposes.

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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)	✓ Available

“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 "Bulk Ingredient For Human Prescription Compounding". 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.

Can I get this product filled at a pharmacy?

Not as listed here. A bulk ingredient NDC identifies drug substance supplied for manufacturing or licensed compounding — it is not a finished, dispensable package. A pharmacy prescription would involve a finished product with its own NDC.

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 65628-070-05, 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: 65628-0070-05, written without dashes as 65628007005. 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 65628-0070-05, the first segment (65628) is the labeler code FDA assigned to Azurity Pharmaceuticals, Inc.; the middle segment (0070) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 1 kit (65628-0070-10), 1 kit (65628-0070-03). 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?

Azurity Pharmaceuticals, Inc. 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.

📄 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 ↗

🔗 Related NDC lookups

🧪 All Omeprazole NDCsSame ingredient 🏭 All Azurity labeler NDCsLabeler code 65628 📖 Read the Omeprazole drug informationUses, warnings & side effects

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Compounding Kit.

Lidocaine/Epinephr/Tetracaine 51552-1345-01 Diphenhyd/Lidocaine/Mag,Al/Sim 65628-0050-01 Lansoprazole 65628-0080-03 Amitriptyline Hcl 76420-0710-06 Baclofen 76420-0930-06 Naproxen 76420-0940-06 Lidocaine Hcl 76420-0960-06 Ibuprofen 76420-0980-06 Cyclobenzaprine Hcl 76420-0991-06

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.