Prescription drug · ANDA
Sucralfate (Sucralfate oral) NDC 65162-062
Sucralfate 1 g/10mL · Suspension · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-062-05 | 6516200620565162006205 | 420 mL in 1 BOTTLE (65162-062-05)Marketed from Dec 2, 2019 | |
| 65162-062-48 | 6516200624865162006248 | 10 CUP, UNIT-DOSE in 1 TRAY (65162-062-48) / 10 mL in 1 CUP, UNIT-DOSE (65162-062-47)Marketed from Dec 2, 2019 |
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 oral
- Active ingredients
- Sucralfate — 1 g/10mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209356
- Marketing start
- Listing expires
- Other FDA classes
- Organometallic Compounds (Chemical structure)
- Identifiers
- Product ID 65162-062_71ed86a3-ff8a-4545-9bae-26632466fd80SPL ID 71ed86a3-ff8a-4545-9bae-26632466fd80SPL set ID 4350b771-76a9-4e00-93f0-a18c71288f83RxCUI 313123UNII 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
N465162006205followed by a unit qualifier and the quantityPackage 65162-0062-05. 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 Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
Excerpt only. Read the full label for complete information.
About NDC 65162-062
- What is NDC 65162-062?
- 65162-062 is the product NDC for Sucralfate (sucralfate oral), Sucralfate 1 g/10mL suspension, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sucralfate (Sucralfate Oral).
- What is the active ingredient?
- Sucralfate.
- 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 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 209356
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 |
|---|---|---|---|---|
| Sucralfatesucralfate oral | Sucralfate 1 g/10mL | SuspensionOral | AvKARE | 42291-781 |
| Sucralfatesucralfate oral | Sucralfate 1 g/10mL | SuspensionOral | AvPAK | 50268-745 |
| Sucralfatesucralfate oral | Sucralfate 1 g/10mL | SuspensionOral | Cardinal Health 107, LLC | 55154-4348 |
| Sucralfatesucralfate oral | Sucralfate 1 g/10mL | SuspensionOral | Precision Dose, Inc. | 68094-041 |