Prescription drug · ANDA
Omeprazole NDC 82804-318
Omeprazole 20 mg/1 · Capsule, Delayed release · Oral · Proficient Rx LP
NDC codes
FDA NDC DirectoryProduct NDC (as listed)82804-318Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0318Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-318-06 | 8280403180682804031806 | 6 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-318-06)Marketed from Sep 23, 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
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078490
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 82804-318_c5e3a37a-f6e3-43d4-a8a9-54db6c271908SPL ID c5e3a37a-f6e3-43d4-a8a9-54db6c271908
- 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
N482804031806followed by a unit qualifier and the quantityPackage 82804-0318-06. 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 82804-318
- What is NDC 82804-318?
- 82804-318 is the product NDC for Omeprazole, Omeprazole 20 mg/1 capsule, delayed release, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omeprazole.
- What is the active ingredient?
- Omeprazole.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. 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 078490
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 10 mg/1 | Capsule, Delayed releaseOral | NorthStar Rx LLC | 16714-630 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NorthStar Rx LLC | 16714-634 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3733 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals, Inc. | 68071-5301 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | PHOENIX RX LLC | 85509-1644 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Quallent Pharmaceuticals Health LLC | 82009-183 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | NorthStar Rx LLC | 16714-123 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-912 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-4177 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6720 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2741 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6721 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-644 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-643 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Dr. Reddy's Laboratories Limited | 55111-645 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Northwind Health Company, LLC | 82868-080 |
| Omeprazole DRomeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0109 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8771 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Redpharm Drug | 67296-1939 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-875 |
Showing 20 of 35.