Prescription drug · ANDA
Sucralfate NDC 72578-081
Sucralfate 1 g/1 · Tablet · Oral · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-081-01 | 7257800810172578008101 | 100 TABLET in 1 BOTTLE (72578-081-01)Marketed from May 20, 2023 | |
| 72578-081-05 | 7257800810572578008105 | 500 TABLET in 1 BOTTLE (72578-081-05)Marketed from May 20, 2023 | |
| 72578-081-06 | 7257800810672578008106 | 30 TABLET in 1 BOTTLE (72578-081-06)Marketed from May 20, 2023 |
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)
- Sucralfate
- Generic name (nonproprietary)
- sucralfate
- Active ingredients
- Sucralfate — 1 g/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Viona Pharmaceuticals IncNDC labeler code 72578
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215705
- Marketing start
- Listing expires
- Other FDA classes
- Organometallic Compounds (Chemical structure)
- Identifiers
- Product ID 72578-081_dd615804-6bb1-4c0a-bafb-7f6c27c55df4SPL ID dd615804-6bb1-4c0a-bafb-7f6c27c55df4SPL set ID c708201b-2618-4470-a3ff-8ecf04d6b3a0RxCUI 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
N472578008101followed by a unit qualifier and the quantityPackage 72578-0081-01. 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 Sucralfate tablets 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 72578-081
- What is NDC 72578-081?
- 72578-081 is the product NDC for Sucralfate, Sucralfate 1 g/1 tablet, listed with the FDA by Viona Pharmaceuticals Inc. It has 3 package NDCs, 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?
- Viona Pharmaceuticals Inc, NDC labeler code 72578. 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 215705
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8653 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Coupler LLC | 67046-1469 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Redpharm Drug | 67296-2147 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3812 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Preferred Pharmaceuticals Inc | 68788-8779 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Zydus Lifesciences Limited | 70771-1833 |
| Sucralfate | Sucralfate 1 g/1 | TabletOral | Bryant Ranch Prepack | 71335-2461 |