Prescription drug · ANDA
Rabeprazole Sodium NDC 71335-1100
Rabeprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1100-2 | 7133511000271335110002 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1100-2)Marketed from Feb 17, 2021 | |
| 71335-1100-3 | 7133511000371335110003 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1100-3)Marketed from Feb 8, 2019 | |
| 71335-1100-4 | 7133511000471335110004 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1100-4)Marketed from Mar 7, 2019 | |
| 71335-1100-5 | 7133511000571335110005 | 28 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1100-5)Marketed from Apr 2, 2024 | |
| 71335-1100-6 | 7133511000671335110006 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1100-6)Marketed from Apr 2, 2024 |
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
- Generic name (nonproprietary)
- rabeprazole sodium
- Active ingredients
- Rabeprazole sodium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- 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 71335-1100_7e855400-3992-4a3d-8aaa-2547eadbf0d2SPL ID 7e855400-3992-4a3d-8aaa-2547eadbf0d2SPL set ID 9ea2552c-873c-4ab2-84b0-dd54e84e4eeeRxCUI 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
N471335110002followed by a unit qualifier and the quantityPackage 71335-1100-02. 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.
About NDC 71335-1100
- What is NDC 71335-1100?
- 71335-1100 is the product NDC for Rabeprazole Sodium, Rabeprazole sodium 20 mg/1 tablet, delayed release, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rabeprazole Sodium.
- What is the active ingredient?
- Rabeprazole sodium.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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?
- 34 other product NDCs are listed under this name. See all Rabeprazole Sodium 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 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 | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-4060 | 68788-4060-0368788-4060-0668788-4060-09 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0449 | 80425-0449-0180425-0449-0280425-0449-03 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0363 | 80425-0363-0180425-0363-0280425-0363-03 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8536 | 68788-8536-0368788-8536-06 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-3209 | 70518-3209-01 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-972 | 60760-0972-0760760-0972-30 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | DIRECT RX | 72189-169 | 72189-0169-3072189-0169-6072189-0169-90 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | DIRECT RX | 72189-142 | 72189-0142-3072189-0142-90 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-2590 | 70518-2590-0070518-2590-01 |
| Rabeprazole Sodium | Rabeprazole sodium 20 mg/1 | Tablet, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-560 | 60760-0560-0760760-0560-3060760-0560-60 |
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 | 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 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 |