Prescription drug · ANDA
Rabeprazole Sodium DR (Rabeprazole sodium) NDC 80425-0094
Rabeprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0094-1 | 8042500940180425009401 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0094-1)Marketed from Apr 27, 2018 | |
| 80425-0094-2 | 8042500940280425009402 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0094-2)Marketed from Apr 27, 2018 | |
| 80425-0094-3 | 8042500940380425009403 | 6 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0094-3)Marketed from Apr 27, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 DRSuffix: DR
- Generic name (nonproprietary)
- rabeprazole sodium
- Active ingredients
- Rabeprazole sodium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- 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 80425-0094_4ceff784-d22b-ca0b-e063-6294a90aa061SPL ID 4ceff784-d22b-ca0b-e063-6294a90aa061SPL set ID b354053c-cb83-79c6-e053-2a95a90afdbeRxCUI 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
N480425009401followed by a unit qualifier and the quantityPackage 80425-0094-01. 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)
1. Indications and Usage Section 1 INDICATIONS & USAGE 1.1 Healing of Erosive or Ulcerative GERD in Adults Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered. 1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulce…
Excerpt only. Read the full label for complete information.
About NDC 80425-0094
- What is NDC 80425-0094?
- 80425-0094 is the product NDC for Rabeprazole Sodium DR (rabeprazole sodium), Rabeprazole sodium 20 mg/1 tablet, delayed release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rabeprazole Sodium DR (Rabeprazole Sodium).
- What is the active ingredient?
- Rabeprazole sodium.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rabeprazole Sodium DR?
- 1 other product NDC are listed under this name. See all Rabeprazole Sodium DR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rabeprazole Sodium DR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rabeprazole Sodium DRrabeprazole sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0134 | 80425-0134-0180425-0134-0280425-0134-03+1 more |
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 | A-S Medication Solutions | 50090-4751 |
| 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 | Ascend Laboratories, LLC | 67877-443 |
| 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 | REMEDYREPACK INC. | 70518-2590 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 71205-292 |
| 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 | Bryant Ranch Prepack | 72162-2367 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | DIRECT RX | 72189-169 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Asclemed USA, Inc. | 76420-818 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | PHOENIX RX LLC | 85509-1443 |
| Rabeprazole Sodium DRrabeprazole sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0134 |