Nystatin
- Product NDC
- 68788-7366
- 11-digit product format
- 687887366
- Labeler code
- 68788
- Product ID
- 68788-7366_5a5a5b62-5da7-4507-a0a0-541de86ce5b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA064022
- Marketing category
- ANDA
- Marketing start
- 2016-08-22
- 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
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68788-7366 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 68788-7366 | 68788-7366-1 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 68788-7366 | 68788-7366-3 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064022-001 | NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM / TOPICAL | AT | RS | 1993-01-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A064022-001 | AT |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A064022-001 | NYSTATIN | 100,000 UNITS/GM | CREAM / TOPICAL | AT | RS | 1993-01-29 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A064022-001 | AT | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nystatin | NYSTATIN | Sun Pharmaceutical Industries, Inc. | 4d845b3f-ca26-4c47-b424-b6d783cc10e5 | 2025-07-03 | Adverse reactions | 064022 ANDA064022 |
| Nystatin | NYSTATIN | NuCare Pharmaceuticals,Inc. | cf6b7c68-7769-1808-e053-2995a90aa426 | 2025-02-10 | Adverse reactions | 064022 ANDA064022 |
| NYSTATIN | NYSTATIN | DIRECT RX | cd387929-5b72-e3c0-e053-2a95a90adb22 | 2025-01-20 | Adverse reactions | 064022 ANDA064022 |
| Nystatin | NYSTATIN | NuCare Pharmaceuticals,Inc. | 57825c04-dcb5-b76d-e053-2991aa0a4c1d | 2024-08-14 | Adverse reactions | 064022 ANDA064022 |
| Nystatin | NYSTATIN | Proficient Rx LP | 5ef15e1c-66dc-4858-8552-d83e42c3883e | 2019-11-01 | Adverse reactions | 064022 ANDA064022 |