Over-the-counter drug · ANDA
Omeprazole NDC 63548-2970
Omeprazole magnesium 20.6 mg/1 · Tablet, Delayed release · Oral · PLD Acquisitions LLC DBA Avma Pharma Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63548-2970-2 | 6354829700263548297002 | 1 BOTTLE, PLASTIC in 1 BOX (63548-2970-2) / 42 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTICMarketed from Oct 31, 2024 | |
| 63548-2970-4 | 6354829700463548297004 | 1 BOTTLE, PLASTIC in 1 BOX (63548-2970-4) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTICMarketed from Oct 31, 2024 | |
| 63548-2970-8 | 6354829700863548297008 | 1 BOTTLE, PLASTIC in 1 BOX (63548-2970-8) / 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTICMarketed from Oct 31, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole magnesium — 20.6 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- PLD Acquisitions LLC DBA Avma Pharma SolutionsNDC labeler code 63548
- 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 63548-2970_2bd05b96-ec80-440b-9e49-53c375ce9f8cSPL ID 2bd05b96-ec80-440b-9e49-53c375ce9f8cSPL set ID d9c8a242-bdba-4f92-8629-692b47ebba21RxCUI 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
N463548297002followed by a unit qualifier and the quantityPackage 63548-2970-02. 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 63548-2970
- What is NDC 63548-2970?
- 63548-2970 is the product NDC for Omeprazole, Omeprazole magnesium 20.6 mg/1 tablet, delayed release, listed with the FDA by PLD Acquisitions LLC DBA Avma Pharma Solutions. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omeprazole.
- What is the active ingredient?
- Omeprazole magnesium.
- Who is the labeler?
- PLD Acquisitions LLC DBA Avma Pharma Solutions, NDC labeler code 63548. 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?
- 252 other product NDCs are listed under this name. See all Omeprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Omeprazole 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 | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Chain Drug Marketing Association, Inc. | 83324-309 | 83324-0309-1483324-0309-42 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-666 | 72288-0666-5572288-0666-74 |
| Omeprazoleomeprazole magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | YYBA CORP | 73581-015 | 73581-0015-03 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Discount Drug Mart, Inc | 53943-038 | 53943-0038-1453943-0038-42 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amazon.com Services LLC | 72288-934 | 72288-0934-01 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | H E B | 59640-699 | 59640-0699-0159640-0699-03 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-063 | 87441-0063-01 |
| Omeprazole | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Safeway | 21130-783 | 21130-0783-0121130-0783-03 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Preferred Phharmaceuticals Inc. | 68788-4104 | 68788-4104-0168788-4104-0268788-4104-03+4 more |
| omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-606 | 72288-0606-03 |
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 | 63548-4080 |
| 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 |
| Prilosec OTComeprazole magnesium | Omeprazole magnesium 20.6 mg/1 | Tablet, Delayed releaseOral | The Procter & Gamble Manufacturing Company | 84126-301 |