Over-the-counter drug · NDA
Prilosec OTC (Omeprazole magnesium) NDC 37000-459
Omeprazole magnesium 20 mg/1 · Tablet, Delayed release · Oral · The Procter & Gamble Manufacturing Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 37000-459-01 | 3700004590137000045901 | 1 TABLET, DELAYED RELEASE in 1 POUCH (37000-459-01)Marketed from Aug 15, 2012 | |
| 37000-459-02 | 3700004590237000045902 | 14 BLISTER PACK in 1 CARTON (37000-459-02) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Aug 15, 2012 | |
| 37000-459-04 | 3700004590437000045904 | 3 CARTON in 1 CARTON (37000-459-04) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Aug 15, 2012 | |
| 37000-459-05 | 3700004590537000045905 | 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (37000-459-05)Marketed from Aug 15, 2012 |
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 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- The Procter & Gamble Manufacturing CompanyNDC labeler code 37000
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021229
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 37000-459_5d19143c-93be-ae16-e063-6294a90a19a6SPL ID 5d19143c-93be-ae16-e063-6294a90a19a6
- 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
N437000045901followed by a unit qualifier and the quantityPackage 37000-0459-01. 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 37000-459
- What is NDC 37000-459?
- 37000-459 is the product NDC for Prilosec OTC (omeprazole magnesium), Omeprazole magnesium 20 mg/1 tablet, delayed release, listed with the FDA by The Procter & Gamble Manufacturing Company. It has 4 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 37000. 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 20.6 mg/1 | Tablet, Delayed releaseOral | The Procter & Gamble Manufacturing Company | 84126-301 | 84126-0301-1484126-0301-42 |
| 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 NDA 021229
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 |
|---|---|---|---|---|
| Prilosec OTComeprazole magnesium | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | The Procter & Gamble Manufacturing Company | 37000-455 |