NDC codes

FDA NDC Directory
Product NDC (as listed)37808-569Labeler and product segments. Claims need a package NDC.
Product NDC at billing width37808-0569Add 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
37808-569-41378080569413 BOTTLE in 1 CARTON (37808-569-41) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 1, 2026
37808-569-45378080569451 BOTTLE in 1 CARTON (37808-569-45) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 1, 2026
37808-569-82378080569822 BOTTLE in 1 CARTON (37808-569-82) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 1, 2026

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 Delayed-Release
Generic name (nonproprietary)
omeprazole
Active ingredients
Omeprazole magnesium — 20 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
H-E-B
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218829
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 37808-569_50962214-2053-1974-e063-6394a90a0fc0SPL ID 50962214-2053-1974-e063-6394a90a0fc0SPL set ID 448ba584-6a6e-3d85-e063-6294a90a5579RxCUI 402014UNII 426QFE7XLK
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

N437808056941 followed by a unit qualifier and the quantity

Package 37808-0569-41. 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 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 218829

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

FDA NDC Directory listings under ANDA 218829
ProductStrengthForm · routeLabelerProduct NDC
Omeprazole delayed releaseomeprazole 20mgOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralTIME CAP LABORATORIES, INC.49483-731
Omeprazole 20 mgOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralMARKSANS PHARMA LIMITED25000-094
Omeprazole 20 mgOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralMARKSANS PHARMA LIMITED25000-091
24 HOUR Omeprazoleomeprazole 20 mgOmeprazole magnesium 20 mg/1Tablet, Delayed releaseOralGrocery Outlet, Inc.85828-731

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