Over-the-counter drug · ANDA
Omeprazole Delayed release (Omeprazole) NDC 61269-720
Omeprazole magnesium 20 mg/1 · Tablet, Delayed release · Oral · H2-Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61269-720-14 | 6126907201461269072014 | 1 BOTTLE in 1 CARTON (61269-720-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 4, 2026 | |
| 61269-720-42 | 6126907204261269072042 | 3 BOTTLE in 1 CARTON (61269-720-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 4, 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 releaseSuffix: Delayed release
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole magnesium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- H2-Pharma, LLCNDC labeler code 61269
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206582
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 61269-720_4e0f8544-4d2c-4d52-92bc-3d2ca162c876SPL ID 4e0f8544-4d2c-4d52-92bc-3d2ca162c876
- 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
N461269072014followed by a unit qualifier and the quantityPackage 61269-0720-14. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 61269-720
- What is NDC 61269-720?
- 61269-720 is the product NDC for Omeprazole Delayed release (omeprazole), Omeprazole magnesium 20 mg/1 tablet, delayed release, listed with the FDA by H2-Pharma, LLC. It has 2 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?
- H2-Pharma, LLC, NDC labeler code 61269. 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 | H-E-B | 37808-569 | 37808-0569-4137808-0569-4537808-0569-82 |
| 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 206582
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 |
|---|---|---|---|---|
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | Walgreens | 0363-9510 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | Family Dollar (FAMILY WELLNESS) | 55319-219 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | P & L Development, LLC | 59726-298 |
| Omeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | P & L Development, LLC | 59726-740 |
| Omeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | P & L Development, LLC | 59726-744 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-2970 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-4080 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-7370 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | PLD Acquisitions LLC DBA Avma Pharma Solutions | 63548-8040 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | WinCo Foods, LLC | 67091-464 |
| Omeprazole | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | WALMART INC. (see also Equate) | 79903-377 |
| Prilosec OTComeprazole magnesium | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | The Procter & Gamble Manufacturing Company | 84126-300 |
| Prilosec OTComeprazole magnesium | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | The Procter & Gamble Manufacturing Company | 84126-301 |