Over-the-counter drug · NDA
exchange select omeprazole (Omeprazole) NDC 55301-915
Omeprazole 20 mg/1 · Tablet, Delayed release · Oral · Army & Air Force Exchange Service
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55301-915-55 | 5530109155555301091555 | 3 CARTON in 1 CARTON (55301-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Oct 28, 2008 | |
| 55301-915-74 | 5530109157455301091574 | 14 BLISTER PACK in 1 CARTON (55301-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Nov 18, 2008 |
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)
- exchange select omeprazole
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Army & Air Force Exchange ServiceNDC labeler code 55301
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022032
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 55301-915_8adc4bc1-677f-4ad1-b301-bb5f25ce0205SPL ID 8adc4bc1-677f-4ad1-b301-bb5f25ce0205SPL set ID 22b4492d-7afe-410f-97bf-57e4a57b1c27RxCUI 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
N455301091555followed by a unit qualifier and the quantityPackage 55301-0915-55. 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 55301-915
- What is NDC 55301-915?
- 55301-915 is the product NDC for exchange select omeprazole (omeprazole), Omeprazole 20 mg/1 tablet, delayed release, listed with the FDA by Army & Air Force Exchange Service. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- exchange select omeprazole (Omeprazole).
- What is the active ingredient?
- Omeprazole.
- Who is the labeler?
- Army & Air Force Exchange Service, NDC labeler code 55301. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for exchange select omeprazole?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 022032
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 |
|---|---|---|---|---|
| 24 hr omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Meijer, Inc. | 79481-0075 |
| basic care omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amazon.com Services LLC | 72288-047 |
| basic care omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amazon.com Services LLC | 72288-401 |
| basic care omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amazon.com Services LLC | 72288-915 |
| Berkley and Jensen Omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | BJWC | 68391-915 |
| care one omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | American Sales Company | 41520-915 |
| careone omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | American Sales Company | 41520-802 |
| careone omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Retail Business Services, LLC | 72476-473 |
| dg health omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Dolgencorp Inc | 55910-215 |
| dg health omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Dolgencorp Inc | 55910-712 |
| dg health omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Dolgencorp, LLC | 55910-915 |
| equaline omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | United Natural Foods, Inc. dba UNFI | 41163-915 |
| equate omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Wal-Mart Stores Inc | 49035-119 |
| equate omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | WALMART INC. | 79903-113 |
| Equate omeprazole delayed release acid reduceromeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Wal-Mart Stores Inc | 49035-915 |
| foster and thrive omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Strategic Sourcing Services LLC | 70677-1104 |
| foster and thrive omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Strategic Sourcing Services LLC | 70677-1275 |
| good neighbor pharmacy omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amerisource Bergen | 46122-029 |
| good neighbor pharmacy omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amerisource Bergen | 46122-281 |
| good now omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Gobrands, Inc | 82501-0915 |
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