Prescription drug · ANDA
Rabeprazole Sodium NDC 76420-818
Rabeprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-818-30 | 76420081830 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-30)Marketed from Jun 25, 2024 | |
| 76420-818-60 | 76420081860 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-60)Marketed from Jun 25, 2024 | |
| 76420-818-90 | 76420081890 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-90)Marketed from Jun 25, 2024 |
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)
- Rabeprazole Sodium
- Generic name (nonproprietary)
- rabeprazole sodium
- Active ingredients
- Rabeprazole sodium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208644
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 76420-818_4ad5e40b-0272-c104-e063-6294a90a8237SPL ID 4ad5e40b-0272-c104-e063-6294a90a8237SPL set ID 3b6a25c2-fb61-4c86-9988-c6ffac7939c4RxCUI 854868UNII 3L36P16U4R
- 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
N476420081830followed by a unit qualifier and the quantityPackage 76420-0818-30. 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)
Rabeprazole sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for: · Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1 ). · Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2 ). · Treatment of Symptomatic GERD ( 1.3 ). · Healing of Duodenal Ulcers ( 1.4 ). · Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence ( 1.5 ). · Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6 ). In adolescent patients 12 years of age and older for: · Short-term Treatment of Symptomatic GERD ( 1.7 ) 1.1 Healing of Erosive or Ulcerative GERD in Adults Rabeprazole sodium delayed-r…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208644
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 |
|---|---|---|---|---|
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Ascend Laboratories, LLC | 67877-443 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | DIRECT RX | 72189-169 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals, Inc. | 68788-7459 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-1100 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-4751 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | PHOENIX RX LLC | 85509-1443 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-2590 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 72162-2367 |
| Rabeprazole Sodium DRrabeprazole sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0094 |
| Rabeprazole Sodium DRrabeprazole sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0134 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-560 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 71205-292 |