Over-the-counter drug · NDA
berkley and jensen omeprazole (Omeprazole) NDC 68391-103
Omeprazole 20 mg/1 · Tablet, Orally disintegrating, Delayed release · Oral · BJWC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68391-103-55 | 6839101035568391010355 | 3 CARTON in 1 CARTON (68391-103-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACKMarketed from Mar 9, 2020 |
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)
- berkley and jensen omeprazole
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 20 mg/1
- Dosage form
- Tablet, Orally disintegrating, Delayed release
- Route
- Oral
- Labeler
- BJWCNDC labeler code 68391
- 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 68391-103_64916be2-9c0a-4eeb-8d44-7e16b1faa8e9SPL ID 64916be2-9c0a-4eeb-8d44-7e16b1faa8e9
- 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
N468391010355followed by a unit qualifier and the quantityPackage 68391-0103-55. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68391-103
- What is NDC 68391-103?
- 68391-103 is the product NDC for berkley and jensen omeprazole (omeprazole), Omeprazole 20 mg/1 tablet, orally disintegrating, delayed release, listed with the FDA by BJWC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- berkley and jensen omeprazole (Omeprazole).
- What is the active ingredient?
- Omeprazole.
- Who is the labeler?
- BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for berkley and jensen omeprazole?
- 1 other product NDC are listed under this name. See all berkley and jensen omeprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other berkley and jensen 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) |
|---|---|---|---|---|---|
| Berkley and Jensen Omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | BJWC | 68391-915 | 68391-0915-55 |
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 |
| 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 |
| equaline omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | United Natural Foods, Inc. dba UNFI | 41163-634 |
| 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 |