Over-the-counter drug · NDA
Leader Omeprazole (Omeprazole) NDC 70000-0381
Omeprazole 20 mg/1 · Tablet, Orally disintegrating, Delayed release · Oral · Cardinal Health 110, LLC. dba Leader
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0381-1 | 7000003810170000038101 | 14 BLISTER PACK in 1 CARTON (70000-0381-1) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACKMarketed from Aug 20, 2018 | |
| 70000-0381-2 | 7000003810270000038102 | 3 CARTON in 1 CARTON (70000-0381-2) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACKMarketed from Aug 20, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Leader Omeprazole
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 20 mg/1
- Dosage form
- Tablet, Orally disintegrating, Delayed release
- Route
- Oral
- Labeler
- Cardinal Health 110, LLC. dba LeaderNDC labeler code 70000
- 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 70000-0381_867caf67-b128-4c09-9e35-352f8c04bcbeSPL ID 867caf67-b128-4c09-9e35-352f8c04bcbeSPL set ID b2dd3c63-3875-4a9b-9b78-b5b3eba2aa1aRxCUI 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
N470000038101followed by a unit qualifier and the quantityPackage 70000-0381-01. 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 70000-0381
- What is NDC 70000-0381?
- 70000-0381 is the product NDC for Leader Omeprazole (omeprazole), Omeprazole 20 mg/1 tablet, orally disintegrating, delayed release, listed with the FDA by Cardinal Health 110, LLC. dba Leader. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Leader Omeprazole (Omeprazole).
- What is the active ingredient?
- Omeprazole.
- Who is the labeler?
- Cardinal Health 110, LLC. dba Leader, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Leader Omeprazole?
- 1 other product NDC are listed under this name. See all Leader Omeprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Leader 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) |
|---|---|---|---|---|---|
| leader omeprazoleomeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Cardinal Health 110, LLC. dba Leader | 70000-0723 | 70000-0723-0170000-0723-0270000-0723-03 |
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 |
| 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 |
| 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 |