Nystatin
- Product NDC
- 68308-152
- 11-digit product format
- 683080152
- Labeler code
- 68308
- Product ID
- 68308-152_9bd397a3-24b8-4420-9adb-9917a8d6b233
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- POWDER
- Route
- TOPICAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA065203
- Marketing category
- ANDA
- Marketing start
- 2004-07-15
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e29fe634-dc25-094c-c77f-5d09c3eceb3e | Product name | 5 | 20260107 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|---|---|---|
| 68308-152-15 | GM - Gram | 68308-152 | c27edf0b-7a4d-4c3b-8682-b7166f85e933 | 1 | 2012-07-24 |
| 68308-152-30 | GM - Gram | 68308-152 | 6f3ce782-3ea6-4f2a-981c-49dee07e5fe1 | 1 | 2012-07-24 |
| 68308-152-60 | GM - Gram | 68308-152 | 2c0c1166-9288-4d7a-b10b-1c4efb9c0c0c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Nystatin | ACTIVE INGREDIENT | BDF1O1C72E | NYSTATIN POWDER [MAYNE PHARMA INC.] | 4 | |
| Nystatin | ACTIVE MOIETY | BDF1O1C72E | NYSTATIN POWDER [MAYNE PHARMA INC.] | 4 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | NYSTATIN POWDER [MAYNE PHARMA INC.] | 4 | |
| Nystatin | ACTIVE INGREDIENT | BDF1O1C72E | NYSTATIN POWDER [REBEL DISTRIBUTORS CORP] | 1 | |
| Nystatin | ACTIVE INGREDIENT | BDF1O1C72E | NYSTATIN POWDER [H.J. HARKINS COMPANY, INC.] | 1 | |
| Nystatin | ACTIVE MOIETY | BDF1O1C72E | NYSTATIN POWDER [REBEL DISTRIBUTORS CORP] | 1 | |
| Nystatin | ACTIVE MOIETY | BDF1O1C72E | NYSTATIN POWDER [H.J. HARKINS COMPANY, INC.] | 1 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | NYSTATIN POWDER [REBEL DISTRIBUTORS CORP] | 1 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | NYSTATIN POWDER [H.J. HARKINS COMPANY, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 646456 | nystatin 100,000 UNT/GM Topical Powder | PSN | 1211504c-f89b-42ed-9d7a-2e1a658a9ccf | 1 |
| 646456 | nystatin 100,000 UNT/GM Topical Powder | PSN | 9e122c5f-65e4-4c92-aaa0-ae97dd725b1a | 1 |
| 646456 | nystatin 100 UNT/MG Topical Powder | SCD | 1211504c-f89b-42ed-9d7a-2e1a658a9ccf | 1 |
| 646456 | nystatin 100 UNT/MG Topical Powder | SCD | 9e122c5f-65e4-4c92-aaa0-ae97dd725b1a | 1 |
| 646456 | nystatin 100,000 UNT/GM Topical Powder | SY | 1211504c-f89b-42ed-9d7a-2e1a658a9ccf | 1 |
| 646456 | nystatin 100,000 UNT/GM Topical Powder | SY | 9e122c5f-65e4-4c92-aaa0-ae97dd725b1a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68308-152-15 | 68308015215 | 15 g in 1 BOTTLE, PLASTIC (68308-152-15) | 15 g | 2004-07-15 | 0000-00-00 | No | No | Current |
| 68308-152-30 | 68308015230 | 30 g in 1 BOTTLE, PLASTIC (68308-152-30) | 30 g | 2004-07-15 | 0000-00-00 | No | No | Current |
| 68308-152-60 | 68308015260 | 60 g in 1 BOTTLE, PLASTIC (68308-152-60) | 60 g | 2004-07-15 | 0000-00-00 | No | No | Current |