Over-the-counter drug · NDA
equaline omeprazole (Omeprazole) NDC 41163-634
Omeprazole 20 mg/1 · Tablet, Orally disintegrating, Delayed release · Oral · United Natural Foods, Inc. dba UNFI
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41163-634-74 | 4116306347441163063474 | 14 BLISTER PACK in 1 CARTON (41163-634-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACKMarketed from Oct 11, 2018 |
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, Orally disintegrating, 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 209400
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 41163-634_d806739f-7f7b-42ae-af48-d1b0b22d3eefSPL ID d806739f-7f7b-42ae-af48-d1b0b22d3eefSPL set ID 78743f3b-257e-49df-98cd-6cc0e1b4e370RxCUI 2003656UNII 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
N441163063474followed by a unit qualifier and the quantityPackage 41163-0634-74. 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 41163-634
- What is NDC 41163-634?
- 41163-634 is the product NDC for equaline omeprazole (omeprazole), Omeprazole 20 mg/1 tablet, orally disintegrating, delayed release, listed with the FDA by United Natural Foods, Inc. dba UNFI. It has 1 package NDC, 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, Delayed releaseOral | United Natural Foods, Inc. dba UNFI | 41163-915 | 41163-0915-0141163-0915-3041163-0915-55+1 more |
Other NDCs under NDA 209400
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 |
|---|---|---|---|---|
| Basic Care Omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-123 |
| berkley and jensen omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | BJWC | 68391-103 |
| careone omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | American Sales Company | 41520-939 |
| DG health omperazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Dolgencorp Inc | 55910-713 |
| good neighbor pharmacy omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amerisource Bergen | 46122-616 |
| good sense omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | L. Perrigo Company | 0113-0520 |
| Leader Omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0381 |
| omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Walgreen Company | 0363-1819 |
| omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Kroger Company | 30142-394 |
| omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | H E B | 37808-354 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Meijer Distribution Inc | 41250-349 |
| omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | HyVee Inc | 42507-164 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | CVS Pharmacy | 69842-791 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-666 |
| Signature Care Omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Safeway | 21130-128 |
| topcare omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Topco Associates LLC | 36800-601 |
| up and up omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Target Corporation | 11673-212 |