Over-the-counter drug · ANDA
Prilosec OTC (Omeprazole magnesium) NDC 84126-301
Omeprazole magnesium 20.6 mg/1 · Tablet, Delayed release · Oral · The Procter & Gamble Manufacturing Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84126-301-14 | 8412603011484126030114 | 1 BLISTER PACK in 1 CARTON (84126-301-14) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jun 3, 2025 | |
| 84126-301-42 | 8412603014284126030142 | 3 BLISTER PACK in 1 CARTON (84126-301-42) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jun 3, 2025 |
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)
- Prilosec OTC
- Generic name (nonproprietary)
- omeprazole magnesium
- Active ingredients
- Omeprazole magnesium — 20.6 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- The Procter & Gamble Manufacturing CompanyNDC labeler code 84126
- 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 84126-301_5d2e3b4d-a8b5-0fc5-e063-6394a90a74d5SPL ID 5d2e3b4d-a8b5-0fc5-e063-6394a90a74d5
- 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
N484126030114followed by a unit qualifier and the quantityPackage 84126-0301-14. 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 84126-301
- What is NDC 84126-301?
- 84126-301 is the product NDC for Prilosec OTC (omeprazole magnesium), Omeprazole magnesium 20.6 mg/1 tablet, delayed release, listed with the FDA by The Procter & Gamble Manufacturing Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prilosec OTC (Omeprazole magnesium).
- What is the active ingredient?
- Omeprazole magnesium.
- Who is the labeler?
- The Procter & Gamble Manufacturing Company, NDC labeler code 84126. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prilosec OTC?
- 3 other product NDCs are listed under this name. See all Prilosec OTC NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prilosec OTC products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Prilosec OTComeprazole magnesium | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | The Procter & Gamble Manufacturing Company | 84126-300 | 84126-0300-1484126-0300-2484126-0300-42+1 more |
| Prilosec OTComeprazole magnesium | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | The Procter & Gamble Manufacturing Company | 37000-459 | 37000-0459-0137000-0459-0237000-0459-04+1 more |
| Prilosec OTComeprazole magnesium | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | The Procter & Gamble Manufacturing Company | 37000-455 | 37000-0455-0137000-0455-0237000-0455-03+2 more |
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 |
| Omeprazole Delayed releaseomeprazole | Omeprazole magnesium 20 mg/1 | Tablet, Delayed releaseOral | H2-Pharma, LLC | 61269-720 |
| Prilosec OTComeprazole magnesium | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | The Procter & Gamble Manufacturing Company | 84126-300 |