Over-the-counter drug · ANDA
Omeprazole NDC 0363-1607
Omeprazole 20 mg/1 · Tablet, Delayed release · Oral · Walgreens Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-1607-14 | 0036316071400363160714 | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)Marketed from Jan 15, 2020 | |
| 0363-1607-28 | 0036316072800363160728 | 2 BOTTLE in 1 CARTON (0363-1607-28) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)Marketed from Jan 15, 2020 | |
| 0363-1607-42 | 0036316074200363160742 | 3 BOTTLE in 1 CARTON (0363-1607-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)Marketed from Jan 15, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Walgreens CompanyNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207740
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0363-1607_663561b1-18c8-7edf-9559-d226dc32a683SPL ID 663561b1-18c8-7edf-9559-d226dc32a683SPL set ID 5e2994fc-8f44-f6e4-71fe-44a215aa93a9RxCUI 402014UNII KG60484QX9
- 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
N400363160714followed by a unit qualifier and the quantityPackage 00363-1607-14. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Use(s) 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 0363-1607
- What is NDC 0363-1607?
- 0363-1607 is the product NDC for Omeprazole, Omeprazole 20 mg/1 tablet, delayed release, listed with the FDA by Walgreens Company. 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.
- Who is the labeler?
- Walgreens Company, NDC labeler code 0363. 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 207740
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 20 mg/1 | Tablet, Delayed releaseOral | Dr. Reddys Laboratories Inc | 43598-286 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Dr. Reddys Laboratories Inc | 43598-841 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | AMERISOURCEBERGEN DRUG CORPORATION | 46122-739 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | BluePoint Laboratories | 68001-441 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Walmart Inc. | 79903-305 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Chain Drug Marketing Association INC | 83324-141 |