Prescription drug · ANDA
Sucralfate NDC 0121-0974
Sucralfate 1 g/10mL · Suspension · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0974-00 | 0012109740000121097400 | 10 TRAY in 1 TRAY (0121-0974-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10)Marketed from Aug 31, 2022 | |
| 0121-0974-40 | 0012109744000121097440 | 4 TRAY in 1 CASE (0121-0974-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10)Marketed from Aug 31, 2022 | |
| 0121-0974-50 | 0012109745000121097450 | 5 PACKAGE in 1 TRAY (0121-0974-50) / 10 CUP, UNIT-DOSE in 1 PACKAGE / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10)Marketed from Aug 31, 2022 | |
| 0121-0974-94 | 0012109749400121097494 | 3 TRAY in 1 CASE (0121-0974-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0974-10)Marketed from Aug 31, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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/10mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211884
- Marketing start
- Listing expires
- Other FDA classes
- Organometallic Compounds (Chemical structure)
- Identifiers
- Product ID 0121-0974_2271d920-944f-42ac-9de4-2c09447a55b3SPL ID 2271d920-944f-42ac-9de4-2c09447a55b3SPL set ID 113a068a-2ce9-421c-8b89-87ce30e19225RxCUI 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
N400121097400followed by a unit qualifier and the quantityPackage 00121-0974-00. 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 0121-0974
- What is NDC 0121-0974?
- 0121-0974 is the product NDC for Sucralfate, Sucralfate 1 g/10mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 4 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?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 211884
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 suspension | Sucralfate 1 g/10mL | SuspensionOral | Major Pharmaceuticals | 0904-7470 |
| Sucralfate | Sucralfate 1 g/10mL | SuspensionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0306 |
| Sucralfate | Sucralfate 1 g/10mL | SuspensionOral | Cardinal Health 107, LLC | 55154-5790 |
| Sucralfate | Sucralfate 1 g/10mL | SuspensionOral | American Health Packaging | 60687-738 |
| Sucralfate | Sucralfate 1 g/10mL | SuspensionOral | VistaPharm, LLC | 66689-305 |