Prescription drug · ANDA
Sucralfate NDC 80425-0091
Sucralfate 1 g/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0091-1 | 8042500910180425009101 | 30 TABLET in 1 BOTTLE (80425-0091-1)Marketed from Nov 11, 1996 |
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)
- Sucralfate
- Generic name (nonproprietary)
- sucralfate
- Active ingredients
- Sucralfate — 1 g/1
- Dosage form
- Tablet
- 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 070848
- Marketing start
- Listing expires
- Other FDA classes
- Organometallic Compounds (Chemical structure)
- Identifiers
- Product ID 80425-0091_2a994dc6-72f5-0559-e063-6394a90a0ecfSPL ID 2a994dc6-72f5-0559-e063-6394a90a0ecfSPL set ID b39f22c8-f224-451a-e053-2995a90aaad7RxCUI 314234UNII XX73205DH5
- Pharmacologic class
- Aluminum Complex
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
N480425009101followed by a unit qualifier and the quantityPackage 80425-0091-01. 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)
Indications and Usage Section INDICATIONS AND USAGE Sucralfate tablets, USP are indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
Excerpt only. Read the full label for complete information.
About NDC 80425-0091
- What is NDC 80425-0091?
- 80425-0091 is the product NDC for Sucralfate, Sucralfate 1 g/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sucralfate.
- What is the active ingredient?
- Sucralfate.
- 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 Sucralfate?
- 65 other product NDCs are listed under this name. See all Sucralfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sucralfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sucralfate | Sucralfate 1 g/10mL | SuspensionOral | Safecor Health, LLC | 48433-226 | 48433-0226-40 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Cardinal Health 107, LLC | 55154-0281 | 55154-0281-00 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Safecor Health LLC | 48433-091 | 48433-0091-20 |
| Sucralfate | Sucralfate 1 g/10mL | SuspensionOral | Torrent Pharmaceuticals Limited | 13668-754 | 13668-0754-42 |
| Sucralfate | Sucralfate 1 g/10mL | SuspensionOral | Chartwell RX, LLC | 62135-106 | 62135-0106-44 |
| Sucralfate | Sucralfate 1 g/10mL | SuspensionOral | Chartwell Governmental & Specialty RX, LLC | 68999-106 | 68999-0106-24 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Coupler LLC | 67046-1469 | 67046-1469-03 |
| Sucralfatesucralfate oral | Sucralfate 1 g/10mL | SuspensionOral | Precision Dose, Inc. | 68094-041 | 68094-0041-6168094-0041-62 |
| Sucralfate | Sucralfate 1 g/10mL | SuspensionOral | Cosette Pharmaceuticals, Inc. | 0713-0791 | 00713-0791-75 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Preferred Pharmaceuticals Inc | 68788-8779 | 68788-8779-0368788-8779-09 |
Other NDCs under ANDA 070848
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 |
|---|---|---|---|---|
| Sucralfate | Sucralfate 1 g/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1749 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | ASCLEMED USA INC. | 87063-176 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Mylan Institutional Inc. | 51079-753 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Proficient Rx LP | 82804-063 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Northwind Health Company, LLC | 51655-031 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Bryant Ranch Prepack | 63629-1307 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Cardinal Health 107, LLC | 55154-4379 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Safecor Health LLC | 48433-091 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8946 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Cardinal Health 107, LLC | 55154-0281 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-2210 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-4517 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | DIRECT RX | 72189-234 |