Nystatin
- Product NDC
- 53489-400
- 11-digit product format
- 534890400
- Labeler code
- 53489
- Product ID
- 53489-400_2628bf08-c7f5-4aef-8e14-bf987eca87ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nystatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA062838
- Marketing category
- ANDA
- Marketing start
- 1988-12-22
- Marketing end
- 0000-00-00
- Substance
- NYSTATIN
- Active strength
- 500000 [USP'U]/1
- 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#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NYSTATIN | ACTIVE INGREDIENT | BDF1O1C72E | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| NYSTATIN | ACTIVE MOIETY | BDF1O1C72E | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, POTATO | INACTIVE INGREDIENT | 8I089SAH3T | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NYSTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53489-400-01 | 53489040001 | 100 TABLET, FILM COATED in 1 BOTTLE (53489-400-01) | 1988-12-22 | 0000-00-00 | No | No | Current |
| 53489-400-02 | 53489040002 | 50 TABLET, FILM COATED in 1 BOTTLE (53489-400-02) | 1988-12-22 | 0000-00-00 | No | No | Current |
| 53489-400-03 | 53489040003 | 250 TABLET, FILM COATED in 1 BOTTLE (53489-400-03) | 1988-12-22 | 0000-00-00 | No | No | Current |
| 53489-400-05 | 53489040005 | 500 TABLET, FILM COATED in 1 BOTTLE (53489-400-05) | 1988-12-22 | 0000-00-00 | No | No | Current |
| 53489-400-10 | 53489040010 | 1000 TABLET, FILM COATED in 1 BOTTLE (53489-400-10) | 1988-12-22 | 0000-00-00 | No | No | Current |