Nystatin and Triamcinolone Acetonide
- Product NDC
- 71335-2857
- Requested package NDC
- 71335-2857-1
- 11-digit product format
- 713352857
- Labeler code
- 71335
- Product ID
- 71335-2857_7e984638-0e98-4e87-9b7a-249d0fca0fe9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nystatin and Triamcinolone Acetonide
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207741
- Marketing category
- ANDA
- Marketing start
- 2019-09-28
- 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 |
|---|---|---|---|---|---|---|---|
| A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207741-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207741-001 | NYSTATIN AND TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT / TOPICAL | AT | 2017-01-31 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207741-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207741-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207741-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207741-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207741-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207741-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207741-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207741-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207741-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207741-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207741-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207741-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207741-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207741-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207741-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207741-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207741-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207741-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207741-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A207741-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207741-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A207741-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A207741-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A207741-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A207741-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A207741-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A207741-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207741-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A207741-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A207741-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207741-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207741-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207741-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207741-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A207741-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A207741-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207741-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A207741-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A207741-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207741-001 | AT | 1 | cb3db0bc1861… |
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#
| Identifier | FDA.report destination |
|---|---|
| 1053697 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 26fd7fb6-6eeb-47f1-bbc4-001e84f99625 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-2857-1 | Nystatin and Triamcinolone Acetonide | 30 g in 1 TUBE | OINTMENT | 30 | 100 | |
| 71335-2857-1 | Nystatin and Triamcinolone Acetonide | 1 in 1 CARTON | OINTMENT | 1 | 100 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-2857-1 | GM - Gram | 71335-2857 | bb6a54c9-5e9b-4ee1-ad22-f2941125321e | 1 | 2025-12-16 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nystatin and Triamcinolone Acetonide | NYSTATIN AND TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | d36c64f7-5481-45e4-ac9c-e16ae2194c6e | 2025-10-22 | Adverse reactions | 207741 ANDA207741 |
| Nystatin and Triamcinolone Acetonide | NYSTATIN AND TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | 26fd7fb6-6eeb-47f1-bbc4-001e84f99625 | 2025-10-22 | Adverse reactions | 207741 ANDA207741 71335-2857-1 71335-2857 71335285701 |
| Nystatin and Triamcinolone Acetonide | NYSTATIN AND TRIAMCINOLONE ACETONIDE | Encube Ethicals, Inc. | d33829fc-86df-4e28-82c3-9dbcd8a9e28d | 2025-08-29 | Adverse reactions | 207741 ANDA207741 |
| Nystatin and Triamcinolone Acetonide | NYSTATIN AND TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | ec28a12b-96f8-44ff-a440-8cff34ac2095 | 2024-11-06 | Adverse reactions | 207741 ANDA207741 |
| Nystatin and Triamcinolone Acetonide | NYSTATIN AND TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | c62979d3-c9a4-4d94-956e-30760266daf4 | 2024-08-20 | Adverse reactions | 207741 ANDA207741 |
| Nystatin and Triamcinolone Acetonide | NYSTATIN AND TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | 3dab5155-9c86-464b-b41b-1507ff49a694 | 2024-06-06 | Adverse reactions | 207741 ANDA207741 |
| Nystatin and Triamcinolone Acetonide | NYSTATIN AND TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | f3e21d77-7ca9-4ca9-97f9-b394f7202aa6 | 2024-03-14 | Adverse reactions | 207741 ANDA207741 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1053697 | nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Ointment | PSN | 26fd7fb6-6eeb-47f1-bbc4-001e84f99625 | 100 |
| 1053697 | nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment | SCD | 26fd7fb6-6eeb-47f1-bbc4-001e84f99625 | 100 |
| 1053697 | nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment | SY | 26fd7fb6-6eeb-47f1-bbc4-001e84f99625 | 100 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-2857-1 | 71335285701 | 1 TUBE in 1 CARTON (71335-2857-1) / 30 g in 1 TUBE | 1 tube | 2025-10-22 | No | No | Current |