Prescription drug · ANDA
Omeprazole NDC 59651-003
Omeprazole 40 mg/1 · Capsule, Delayed release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-003-01 | 59651000301 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-003-01)Marketed from Aug 19, 2015 | |
| 59651-003-03 | 59651000303 | 3 BLISTER PACK in 1 CARTON (59651-003-03) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-003-10)Marketed from Aug 19, 2015 | |
| 59651-003-05 | 59651000305 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-003-05)Marketed from Aug 19, 2015 | |
| 59651-003-30 | 59651000330 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-003-30)Marketed from Aug 19, 2015 | |
| 59651-003-78 | 59651000378 | 10 BLISTER PACK in 1 CARTON (59651-003-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-003-10)Marketed from Aug 19, 2015 | |
| 59651-003-90 | 59651000390 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-003-90)Marketed from Aug 19, 2015 | |
| 59651-003-99 | 59651000399 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-003-99)Marketed from May 3, 2019 |
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)
- Omeprazole
- Generic name (nonproprietary)
- omeprazole
- Active ingredients
- Omeprazole — 40 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203270
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-003_4cc78adf-d6a3-47b6-bc25-9d3f28d2a27aSPL ID 4cc78adf-d6a3-47b6-bc25-9d3f28d2a27aSPL set ID 934601b6-fbba-43c4-a8ef-7a7dfe9f9a51RxCUI 198051, 199119, 200329UNII KG60484QX9UPC 0359651001301, 0359651002308, 0359651003305
- 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
N459651000301followed by a unit qualifier and the quantityPackage 59651-0003-01. 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)
Omeprazole is 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 ulcer in adults. Most patie…
Excerpt only. Read the full label for complete information.
About NDC 59651-003
- What is NDC 59651-003?
- 59651-003 is the product NDC for Omeprazole, Omeprazole 40 mg/1 capsule, delayed release, listed with the FDA by Aurobindo Pharma Limited. It has 7 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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?
- 249 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 20 mg/1 | Tablet, Orally disintegrating, Delayed releaseOral | Amazon.com Services LLC | 72288-666 | 72288-0666-55 |
| Omeprazole | Omeprazole 20 mg/1 | Tablet, Delayed releaseOral | Discount Drug Mart, Inc | 53943-038 | 53943-0038-1453943-0038-42 |
| 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 | 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 |
| Omeprazole | Omeprazole magnesium 20 mg/1 | Capsule, Delayed releaseOral | Walgreen Company | 0363-4099 | 00363-4099-03 |
Other NDCs under ANDA 203270
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 | QPharma, Inc. | 42708-159 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | QPharma Inc | 42708-199 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7213 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7214 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7215 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7366 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7367 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Northwind Health Company, LLC | 51655-452 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Rising Pharma Holdings, Inc. | 57237-160 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Rising Pharma Holdings, Inc. | 57237-161 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Rising Pharma Holdings, Inc. | 57237-162 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Aurobindo Pharma Limited | 59651-001 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Aurobindo Pharma Limited | 59651-002 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2262 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Preferred Phharmaceuticals Inc. | 68788-4104 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1851 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1852 |
| Omeprazole | Omeprazole 40 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 72162-2388 |
| Omeprazole | Omeprazole 10 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 82804-280 |
| Omeprazole | Omeprazole 20 mg/1 | Capsule, Delayed releaseOral | Northwind Health Company, LLC | 82868-043 |