Prescription drug · ANDA
Nystatin NDC 0121-0868
Nystatin 100000 [USP'U]/mL · Suspension · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-0868-00 | 0012108680000121086800 | 10 TRAY in 1 CASE (0121-0868-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)Marketed from Jul 17, 2020 | |
| 0121-0868-02 | 0012108680200121086802 | 60 mL in 1 BOTTLE, DROPPER (0121-0868-02)Marketed from Jul 17, 2020 | |
| 0121-0868-16 | 0012108681600121086816 | 473 mL in 1 BOTTLE (0121-0868-16)Marketed from Jul 17, 2020 | |
| 0121-0868-50 | 0012108685000121086850 | 5 TRAY in 1 CASE (0121-0868-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)Marketed from Jul 17, 2020 |
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)
- Nystatin
- Generic name (nonproprietary)
- nystatin
- Active ingredients
- Nystatin — 100000 [USP'U]/mL
- 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 203621
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 0121-0868_7d265612-edc5-42bc-8e58-bae7d7ab7918SPL ID 7d265612-edc5-42bc-8e58-bae7d7ab7918SPL set ID 28b4e26e-206a-4e8a-abfe-774b780e91c3RxCUI 312055UNII BDF1O1C72EUPC 0301210868160, 0301210868023
- Pharmacologic class
- Polyene Antifungal
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
N400121086800followed by a unit qualifier and the quantityPackage 00121-0868-00. 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 Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
Excerpt only. Read the full label for complete information.
About NDC 0121-0868
- What is NDC 0121-0868?
- 0121-0868 is the product NDC for Nystatin, Nystatin 100000 [USP'U]/mL 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?
- Nystatin.
- What is the active ingredient?
- Nystatin.
- 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 Nystatin?
- 77 other product NDCs are listed under this name. See all Nystatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nystatin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-4099 | 68788-4099-01 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | Genus Lifesciences Inc. | 64950-372 | 64950-0372-0664950-0372-47 |
| Nystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Northstar Rx LLC | 72603-491 | 72603-0491-0172603-0491-0272603-0491-03 |
| Nystatin | Nystatin 100000 [USP'U]/g | CreamTopical | Aurobindo Pharma Limited | 59651-907 | 59651-0907-1459651-0907-30 |
| nystatin | Nystatin 500000 [USP'U]/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-8690 | 68788-8690-01 |
| Nystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Dr. Reddy's Labratories Inc. | 75907-060 | 75907-0060-3075907-0060-4475907-0060-60 |
| Nystatin | Nystatin 100000 U/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8631 | 68788-8631-0168788-8631-03 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | American Health Packaging | 60687-800 | 60687-0800-17 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | Preferred Pharmaceuticals Inc. | 68788-8561 | 68788-8561-0468788-8561-06 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0508 | 17856-0508-0117856-0508-0317856-0508-05+1 more |
Other NDCs under ANDA 203621
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 |
|---|---|---|---|---|
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | Pharmaceutical Associates, Inc. | 0121-0810 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | Pharmaceutical Associates, Inc. | 0121-4810 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | Major Pharmaceuticals | 0904-7276 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | A-S Medication Solutions | 50090-5315 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | Cardinal Health 107, LLC | 55154-4314 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | Cardinal Health 107, LLC | 55154-5788 |
| Nystatin | Nystatin 100000 [USP'U]/mL | SuspensionOral | American Health Packaging | 60687-800 |