Prescription drug · ANDA
Rabeprazole Sodium NDC 62135-503
Rabeprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-503-30 | 62135050330 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-503-30)Marketed from Apr 27, 2023 | |
| 62135-503-90 | 62135050390 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (62135-503-90)Marketed from Apr 27, 2023 |
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
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090678
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-503_45adfadd-b711-a916-e063-6394a90ac34cSPL ID 45adfadd-b711-a916-e063-6394a90ac34cSPL set ID c5c43222-d167-4152-b5c7-84b55920a7ceRxCUI 854868UNII 3L36P16U4RUPC 0362135503307
- 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
N462135050330followed by a unit qualifier and the quantityPackage 62135-0503-30. 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 are 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 the 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-Release T…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090678
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 | Proficient Rx LP | 63187-259 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-184 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Lannett Company, Inc. | 62175-302 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-0244 |