Nystatin and Triamcinolone Acetonide
- Product NDC
- 51672-1263
- Requested package NDC
- 51672-1263-3
- 11-digit product format
- 516721263
- Labeler code
- 51672
- Product ID
- 51672-1263_395e7f1c-ecc8-31cf-e063-6294a90aef62
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin and Triamcinolone Acetonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA062364
- Marketing category
- ANDA
- Marketing start
- 1987-12-22
- Substance
- NYSTATIN; TRIAMCINOLONE ACETONIDE
- Active strength
- 100000; 1 [USP'U]/g; mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062364-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM / TOPICAL | AT | RS | 1987-12-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A062364-001 | 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 | A062364-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM / TOPICAL | AT | RS | 1987-12-22 | 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 | A062364-001 | 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 and Triamcinolone Acetonide | NYSTATIN AND TRIAMCINOLONE ACETONIDE | REMEDYREPACK INC. | ea065dd4-dfd3-46a2-92de-8a0b49cb9455 | 2026-01-14 | Adverse reactions | 062364 ANDA062364 |
| Nystatin and Triamcinolone Acetonide | NYSTATIN AND TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | 4fd65dbf-8e50-4a4a-b06d-e5abab0f3dcd | 2025-08-28 | Adverse reactions | 062364 ANDA062364 |
| Nystatin and Triamcinolone Acetonide | NYSTATIN AND TRIAMCINOLONE ACETONIDE | Sun Pharmaceutical Industries, Inc. | 2fd97fc5-cae5-43dd-a3c7-c9a03876153e | 2025-07-07 | Adverse reactions | 062364 ANDA062364 51672-1263-3 51672-1263 51672126303 |
| Nystatin and Triamcinolone Acetonide | NYSTATIN AND TRIAMCINOLONE ACETONIDE | NuCare Pharmaceuticals,Inc. | 90a58c0e-85cf-3aad-e053-2a95a90a316a | 2024-06-19 | Adverse reactions | 062364 ANDA062364 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nystatin and Triamcinolone Acetonide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NYSTATIN | 100000 [USP'U]/g |
| TRIAMCINOLONE ACETONIDE | 1 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| BDF1O1C72E | Internal UNII lookup |
| F446C597KA | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2fd97fc5-cae5-43dd-a3c7-c9a03876153e | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51672-1263-1 | Nystatin and Triamcinolone Acetonide | 15 g in 1 TUBE | CREAM | 15 | 6 | |
| 51672-1263-1 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | 6 | |
| 51672-1263-2 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | 6 | |
| 51672-1263-2 | Nystatin and Triamcinolone Acetonide | 30 g in 1 TUBE | CREAM | 30 | 6 | |
| 51672-1263-3 | Nystatin and Triamcinolone Acetonide | 60 g in 1 TUBE | CREAM | 60 | 6 | |
| 51672-1263-3 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | CREAM | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-1263-1 | GM - Gram | 51672-1263 | d146d1bc-ab7d-4a38-b5bc-34a904668426 | 1 | 2012-07-24 |
| 51672-1263-2 | GM - Gram | 51672-1263 | 253f1035-667d-458c-b764-cdca0c2a2d1e | 1 | 2012-07-24 |
| 51672-1263-3 | GM - Gram | 51672-1263 | a32ae7e9-c681-4a95-a292-ec3c29623c27 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51672-1263 | NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20241222_2fd97fc5-cae5-43dd-a3c7-c9a03876153e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1053753 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream | PSN | ea065dd4-dfd3-46a2-92de-8a0b49cb9455 | 11 |
| 1053753 | nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SCD | ea065dd4-dfd3-46a2-92de-8a0b49cb9455 | 11 |
| 1053753 | nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SY | ea065dd4-dfd3-46a2-92de-8a0b49cb9455 | 11 |
| 1053753 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream | PSN | 2fd97fc5-cae5-43dd-a3c7-c9a03876153e | 6 |
| 1053697 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Ointment | PSN | 2fd97fc5-cae5-43dd-a3c7-c9a03876153e | 6 |
| 1053697 | nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment | SCD | 2fd97fc5-cae5-43dd-a3c7-c9a03876153e | 6 |
| 1053753 | nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SCD | 2fd97fc5-cae5-43dd-a3c7-c9a03876153e | 6 |
| 1053697 | nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment | SY | 2fd97fc5-cae5-43dd-a3c7-c9a03876153e | 6 |
| 1053753 | nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SY | 2fd97fc5-cae5-43dd-a3c7-c9a03876153e | 6 |
| 1053753 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream | PSN | e935821e-4e1b-4b5c-b943-5332c0b7a76b | 4 |
| 1053753 | nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SCD | e935821e-4e1b-4b5c-b943-5332c0b7a76b | 4 |
| 1053753 | nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SY | e935821e-4e1b-4b5c-b943-5332c0b7a76b | 4 |
| 1053753 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream | PSN | 4fd65dbf-8e50-4a4a-b06d-e5abab0f3dcd | 3 |
| 1053753 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream | PSN | 90a58c0e-85cf-3aad-e053-2a95a90a316a | 3 |
| 1053753 | nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SCD | 4fd65dbf-8e50-4a4a-b06d-e5abab0f3dcd | 3 |
| 1053753 | nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SCD | 90a58c0e-85cf-3aad-e053-2a95a90a316a | 3 |
| 1053753 | nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SY | 4fd65dbf-8e50-4a4a-b06d-e5abab0f3dcd | 3 |
| 1053753 | nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SY | 90a58c0e-85cf-3aad-e053-2a95a90a316a | 3 |
| 1053753 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream | PSN | 54af3d6a-d536-4df8-89ca-26acbe672400 | 2 |
| 1053753 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream | PSN | 779bc07c-50a5-4439-adfa-c4540834f19c | 2 |
| 1053753 | nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SCD | 779bc07c-50a5-4439-adfa-c4540834f19c | 2 |
| 1053753 | nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SCD | 54af3d6a-d536-4df8-89ca-26acbe672400 | 2 |
| 1053753 | nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SY | 779bc07c-50a5-4439-adfa-c4540834f19c | 2 |
| 1053753 | nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SY | 54af3d6a-d536-4df8-89ca-26acbe672400 | 2 |
| 1053753 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream | PSN | 9b245d7c-00c0-472e-b213-13fbe9973ee1 | 1 |
| 1053753 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream | PSN | 358dfb19-6834-4874-8dbc-9857349789be | 1 |
| 1053753 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream | PSN | 05bd45bc-d683-e60c-e063-6394a90abe1a | 1 |
| 1053753 | nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SCD | 05bd45bc-d683-e60c-e063-6394a90abe1a | 1 |
| 1053753 | nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SCD | 9b245d7c-00c0-472e-b213-13fbe9973ee1 | 1 |
| 1053753 | nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SCD | 358dfb19-6834-4874-8dbc-9857349789be | 1 |
| 1053753 | nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SY | 9b245d7c-00c0-472e-b213-13fbe9973ee1 | 1 |
| 1053753 | nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SY | 358dfb19-6834-4874-8dbc-9857349789be | 1 |
| 1053753 | nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream | SY | 05bd45bc-d683-e60c-e063-6394a90abe1a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51672-1263-3 | 51672126303 | 1 TUBE in 1 CARTON (51672-1263-3) / 60 g in 1 TUBE | 1 tube | 1987-12-22 | 0000-00-00 | No | No | Current |