Nystatin
- Product NDC
- 0168-0007
- 11-digit product format
- 001680007
- Labeler code
- 0168
- Product ID
- 0168-0007_2563e491-2277-4393-8632-8127fb983e1d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nystatin
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Application
- ANDA062124
- Marketing category
- ANDA
- Marketing start
- 1982-09-23
- Marketing end
- 0000-00-00
- Substance
- NYSTATIN
- Active strength
- 100000 [USP'U]/g
- Pharmacologic classes
- Polyene Antifungal [EPC],Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e29fe634-dc25-094c-c77f-5d09c3eceb3e | Product name | 5 | 20260107 |
| e57b6340-9387-3f9a-7307-511c81791375 | Product name | 3 | 20221214 |
| 544f8e8d-6389-eeeb-9586-aa447c08dcc7 | Product name | 5 | 20210614 |
| 1629e00f-54fb-4a43-8306-b58442b23902 | Product name | 9 | 20200430 |
| 854ec07b-1cd7-a5db-235a-7aa24d3cf97a | Product name | 3 | 20180628 |
| 19b9f4c1-15e9-edcc-4c16-f01ecfb5c549 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0168-0007-15 | GM - Gram | 0168-0007 | 52751ca1-1910-4597-8fa6-faa22e9bacab | 1 | 2012-07-24 |
| 0168-0007-30 | GM - Gram | 0168-0007 | e865dc45-e1a9-4f36-b7cc-2aa04b9958ec | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| nystatin | ACTIVE INGREDIENT | BDF1O1C72E | NYSTATIN OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| nystatin | ACTIVE MOIETY | BDF1O1C72E | NYSTATIN OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | NYSTATIN OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| Mineral Oil | INACTIVE INGREDIENT | T5L8T28FGP | NYSTATIN OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| nystatin | ACTIVE INGREDIENT | BDF1O1C72E | NYSTATIN OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| nystatin | ACTIVE MOIETY | BDF1O1C72E | NYSTATIN OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | NYSTATIN OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| Mineral Oil | INACTIVE INGREDIENT | T5L8T28FGP | NYSTATIN OINTMENT [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 884308 | nystatin 100,000 UNT/GM Topical Ointment | PSN | db8e62a1-9a5e-49d1-8c6b-64a3e083487c | 3 |
| 884308 | nystatin 100 UNT/MG Topical Ointment | SCD | db8e62a1-9a5e-49d1-8c6b-64a3e083487c | 3 |
| 884308 | nystatin 100,000 UNT/GM Topical Ointment | SY | db8e62a1-9a5e-49d1-8c6b-64a3e083487c | 3 |
| 884308 | nystatin 100,000 UNT/GM Topical Ointment | PSN | da4cd3fc-906d-4468-b7f9-c20f085c95ed | 1 |
| 884308 | nystatin 100 UNT/MG Topical Ointment | SCD | da4cd3fc-906d-4468-b7f9-c20f085c95ed | 1 |
| 884308 | nystatin 100,000 UNT/GM Topical Ointment | SY | da4cd3fc-906d-4468-b7f9-c20f085c95ed | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0168-0007-15 | 00168000715 | 15 g in 1 TUBE (0168-0007-15) | 15 g | 1982-09-23 | 0000-00-00 | No | No | Current |
| 0168-0007-30 | 00168000730 | 30 g in 1 TUBE (0168-0007-30) | 30 g | 1982-09-23 | 0000-00-00 | No | No | Current |