Prescription drug · ANDA
Omeprazole NDC 0615-8079
Omeprazole 40 mg/1 · Capsule, Delayed release · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8079-05 | 0061580790500615807905 | 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-05)Marketed from Oct 31, 2014 | |
| 0615-8079-07 | 0061580790700615807907 | 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-07)Marketed from Nov 2, 2018 | |
| 0615-8079-28 | 0061580792800615807928 | 28 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-28)Marketed from Jan 10, 2025 | |
| 0615-8079-39 | 0061580793900615807939 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-39)Marketed from Oct 31, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Omeprazole
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 40 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091672
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 0615-8079_0c6e0de8-3ef8-4745-9ce4-d52f7c28bde3SPL ID 0c6e0de8-3ef8-4745-9ce4-d52f7c28bde3SPL set ID d1e0c8fc-1f15-45a4-a80f-653a1dae5e56RxCUI 200329UNII 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
N400615807905followed by a unit qualifier and the quantityPackage 00615-8079-05. 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)
Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Treatment of active benign gastric ulcer in adults ( 1.3 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4 ) Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older ( 1.6 ) Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal u…
Excerpt only. Read the full label for complete information.
About NDC 0615-8079
- What is NDC 0615-8079?
- 0615-8079 is the product NDC for Omeprazole, Omeprazole 40 mg/1 capsule, delayed release, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omeprazole.
- What is the active ingredient?
- Omeprazole.
- Who is the labeler?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Omeprazole?
- 252 other product NDCs are listed under this name. See all Omeprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 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) |
|---|---|---|---|---|---|
| Omeprazole | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Chain Drug Marketing Association, Inc. | 83324-309 | 83324-0309-1483324-0309-42 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-666 | 72288-0666-5572288-0666-74 |
| Omeprazoleomeprazole magnesium | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | YYBA CORP | 73581-015 | 73581-0015-03 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Discount Drug Mart, Inc | 53943-038 | 53943-0038-1453943-0038-42 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Amazon.com Services LLC | 72288-934 | 72288-0934-01 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | H E B | 59640-699 | 59640-0699-0159640-0699-03 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Unit Dose Solutions, Inc. | 87441-063 | 87441-0063-01 |
| Omeprazole | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Safeway | 21130-783 | 21130-0783-0121130-0783-03 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Preferred Phharmaceuticals Inc. | 68788-4104 | 68788-4104-0168788-4104-0268788-4104-03+4 more |
| omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Amazon.com Services LLC | 72288-606 | 72288-0606-03 |
Other NDCs under ANDA 091672
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 |
|---|---|---|---|---|
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-2769 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-3876 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-5111 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-5501 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-841 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-820 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-828 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | NuCarePharmaceuticals, Inc. | 68071-2199 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-3007 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4024 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-395 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-396 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-397 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-6881 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-6995 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-0199 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-2251 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 71205-501 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-0299 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1639 |
Showing 20 of 32.