Over-the-counter drug · NDA
equaline omeprazole (Omeprazole) NDC 41163-915
Omeprazole 20 mg/1 · Tablet, Delayed release · Oral · United Natural Foods, Inc. dba UNFI
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41163-915-01 | 4116309150141163091501 | 1 BOTTLE in 1 CARTON (41163-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 27, 2011 | |
| 41163-915-30 | 4116309153041163091530 | 2 CARTON in 1 CARTON (41163-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Feb 22, 2008 | |
| 41163-915-55 | 4116309155541163091555 | 3 CARTON in 1 CARTON (41163-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Feb 25, 2008 | |
| 41163-915-74 | 4116309157441163091574 | 14 BLISTER PACK in 1 CARTON (41163-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Feb 22, 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)
- equaline omeprazole
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- United Natural Foods, Inc. dba UNFINDC labeler code 41163
- 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 41163-915_9cf01d8d-1fe8-4350-a23b-065f4d126547SPL ID 9cf01d8d-1fe8-4350-a23b-065f4d126547SPL set ID b6c87a6a-253a-4455-9b7d-62f506da592eRxCUI 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
N441163091501followed by a unit qualifier and the quantityPackage 41163-0915-01. 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
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 41163-915
- What is NDC 41163-915?
- 41163-915 is the product NDC for equaline omeprazole (omeprazole), Omeprazole 20 mg/1 tablet, delayed release, listed with the FDA by United Natural Foods, Inc. dba UNFI. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- equaline omeprazole (Omeprazole).
- What is the active ingredient?
- Omeprazole.
- Who is the labeler?
- United Natural Foods, Inc. dba UNFI, NDC labeler code 41163. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for equaline omeprazole?
- 1 other product NDC are listed under this name. See all equaline omeprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other equaline 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) |
|---|---|---|---|---|---|
| equaline omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | United Natural Foods, Inc. dba UNFI | 41163-634 | 41163-0634-74 |
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 |
| 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 |
| exchange select omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Army & Air Force Exchange Service | 55301-915 |
| 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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