Prescription drug · ANDA
Rabeprazole sodium NDC 13668-107
Rabeprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-107-30 | 13668010730 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-30)Marketed from Nov 8, 2013 | |
| 13668-107-90 | 13668010790 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-107-90)Marketed from Nov 8, 2013 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202376
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 13668-107_cd95d6fc-099e-4ba3-98f1-b30a2301c268SPL ID cd95d6fc-099e-4ba3-98f1-b30a2301c268SPL set ID 04e88b86-e1dd-4c56-8359-45fbcc161f7dRxCUI 854868UNII 3L36P16U4RUPC 0313668107302
- 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
N413668010730followed by a unit qualifier and the quantityPackage 13668-0107-30. 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-release tablet…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202376
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 | 63187-555 |
| Rabeprazole sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-4060 |