NDC codes

FDA NDC Directory
Product NDC (as listed)43598-841Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0841Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
43598-841-42435980841423 BOTTLE in 1 CARTON (43598-841-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Oct 1, 2020
43598-841-52435980841521 BOTTLE in 1 CARTON (43598-841-52) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Oct 1, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Omeprazole
Generic name (nonproprietary)
omeprazole
Active ingredients
Omeprazole20 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207740
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 43598-841_bf20de45-af46-d037-efd5-6efe069d0569SPL ID bf20de45-af46-d037-efd5-6efe069d0569SPL set ID b377cb0b-14b2-04bb-f276-fd69a257f9caRxCUI 402014UNII KG60484QX9
Pharmacologic class
Proton Pump Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N443598084142 followed by a unit qualifier and the quantity

Package 43598-0841-42. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Use(s) 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207740

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 207740
ProductStrengthForm · routeLabelerProduct NDC
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralAMERISOURCEBERGEN DRUG CORPORATION46122-739
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralWalmart Inc.79903-305
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralWalgreens Company0363-1607
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralChain Drug Marketing Association INC83324-141
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralDr. Reddys Laboratories Inc43598-286
OmeprazoleOmeprazole 20 mg/1Tablet, Delayed releaseOralBluePoint Laboratories68001-441

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in