Prescription drug · ANDA
Rabeprazole Sodium (Rabeprazole) NDC 65162-724
Rabeprazole sodium 20 mg/1 · Tablet, Delayed release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-724-03 | 6516207240365162072403 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-03)Marketed from Oct 1, 2015 | |
| 65162-724-09 | 6516207240965162072409 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-09)Marketed from Oct 1, 2015 | |
| 65162-724-11 | 6516207241165162072411 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-11)Marketed from Oct 1, 2015 | |
| 65162-724-50 | 6516207245065162072450 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-724-50)Marketed from Oct 1, 2015 |
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
- Active ingredients
- Rabeprazole sodium — 20 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204179
- Marketing start
- Listing expires
- Other FDA classes
- Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 65162-724_f02b0373-dbac-4842-bf97-3352b8c74089SPL ID f02b0373-dbac-4842-bf97-3352b8c74089SPL set ID 951caefe-6e18-48ff-9567-beb545b09c25RxCUI 854868UNII 3L36P16U4RUPC 0365162724035
- 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
N465162072403followed by a unit qualifier and the quantityPackage 65162-0724-03. 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 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 table…
Excerpt only. Read the full label for complete information.
About NDC 65162-724
- What is NDC 65162-724?
- 65162-724 is the product NDC for Rabeprazole Sodium (rabeprazole), Rabeprazole sodium 20 mg/1 tablet, delayed release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rabeprazole Sodium (Rabeprazole).
- What is the active ingredient?
- Rabeprazole sodium.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 |