Nystatin
- Product NDC
- 0093-0983
- 11-digit product format
- 000930983
- Labeler code
- 0093
- Product ID
- 0093-0983_b55205c3-f0be-44eb-a267-3af07c1639f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA062506
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Substance
- NYSTATIN
- Active strength
- 500000 [USP'U]/1
- Pharmacologic classes
- Polyene Antifungal [EPC], Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nystatin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NYSTATIN | 500000 [USP'U]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BDF1O1C72E |
| Rxcui | 312059 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-0983-01 | Nystatin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NYSTATIN | ACTIVE INGREDIENT | BDF1O1C72E | NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| NYSTATIN | ACTIVE MOIETY | BDF1O1C72E | NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| NYSTATIN | ACTIVE INGREDIENT | BDF1O1C72E | NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 3 | |
| NYSTATIN | ACTIVE MOIETY | BDF1O1C72E | NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 3 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 3 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NYSTATIN TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 3 | |
| NYSTATIN | ACTIVE INGREDIENT | BDF1O1C72E | NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| NYSTATIN | ACTIVE MOIETY | BDF1O1C72E | NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NYSTATIN (NYSTATIN) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-0983 | NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20240207_f03b294d-10cd-4bba-92c8-42ae9b110cd0.zip |
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 |
|---|
| 0093-0983-01 | 00093098301 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-0983-01) | 1990-09-30 | 0000-00-00 | No | No | Current |
| 0093-0983-99 | 00093098399 | 681818 TABLET, FILM COATED in 1 PAIL (0093-0983-99) | 23-JUN-23 | | | | Current |