Over-the-counter drug · ANDA
Omeprazole Delayed-Release (Omeprazole) NDC 37808-569
Omeprazole magnesium 20 mg/1 · Tablet, Delayed release · Oral · H-E-B
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 37808-569-41 | 3780805694137808056941 | 3 BOTTLE in 1 CARTON (37808-569-41) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 1, 2026 | |
| 37808-569-45 | 3780805694537808056945 | 1 BOTTLE in 1 CARTON (37808-569-45) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 1, 2026 | |
| 37808-569-82 | 3780805698237808056982 | 2 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-BNDC labeler code 37808
- 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
N437808056941followed by a unit qualifier and the quantityPackage 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.
About NDC 37808-569
- What is NDC 37808-569?
- 37808-569 is the product NDC for Omeprazole Delayed-Release (omeprazole), Omeprazole magnesium 20 mg/1 tablet, delayed release, listed with the FDA by H-E-B. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omeprazole Delayed-Release (Omeprazole).
- What is the active ingredient?
- Omeprazole magnesium.
- Who is the labeler?
- H-E-B, NDC labeler code 37808. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Omeprazole Delayed-Release?
- 2 other product NDCs are listed under this name. See all Omeprazole Delayed-Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Omeprazole Delayed-Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Omeprazole Delayed releaseomeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | H2-Pharma, LLC | 61269-720 | 61269-0720-1461269-0720-42 |
| Omeprazole delayed releaseomeprazole 20mg | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | TIME CAP LABORATORIES, INC. | 49483-731 | 49483-0731-41 |
Other NDCs under ANDA 218829
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 24 HOUR Omeprazoleomeprazole 20 mg | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | Grocery Outlet, Inc. | 85828-731 |
| Omeprazole 20 mg | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | MARKSANS PHARMA LIMITED | 25000-091 |
| Omeprazole 20 mg | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | MARKSANS PHARMA LIMITED | 25000-094 |
| Omeprazole delayed releaseomeprazole 20mg | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | TIME CAP LABORATORIES, INC. | 49483-731 |