Triamcinolone acetonide
- Product NDC
- 63629-8778
- 11-digit product format
- 636298778
- Labeler code
- 63629
- Product ID
- 63629-8778_05c169b6-4765-453f-b821-163992660ac0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Triamcinolone acetonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA088042
- Marketing category
- ANDA
- Marketing start
- 2012-04-01
- Substance
- TRIAMCINOLONE ACETONIDE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- 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 |
|---|---|---|---|---|---|---|---|
| A088042-001 | TRIDERM | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | |
| A088042-002 | TRIDERM | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | |
| A088042-003 | TRIDERM | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A088042-001 | AT |
| A088042-002 | AT |
| A088042-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088042-002 | TRIDERM | 0.025% | CREAM / TOPICAL | AT | 2015-03-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088042-003 | TRIDERM | 0.5% | CREAM / TOPICAL | AT | 2015-03-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088042-001 | TRIDERM | 0.1% | CREAM / TOPICAL | AT | 1984-03-19 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A088042-001 | AT | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A088042-002 | AT | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A088042-003 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A088042-001 | AT | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A088042-002 | AT | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A088042-003 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A088042-001 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A088042-002 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A088042-003 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088042-001 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088042-002 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088042-003 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A088042-001 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A088042-002 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A088042-003 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088042-001 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088042-002 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088042-003 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088042-001 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088042-002 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088042-003 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088042-001 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088042-002 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088042-003 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088042-001 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088042-002 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088042-003 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088042-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088042-002 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088042-003 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088042-001 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088042-002 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088042-003 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A088042-001 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A088042-002 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A088042-003 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088042-001 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088042-002 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088042-003 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088042-001 | AT | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Triamcinolone acetonide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRIAMCINOLONE ACETONIDE | 1 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F446C597KA | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1014314 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0bf47993-615c-4d89-8e02-145f59315362 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-8778-1 | Triamcinolone acetonide | 15 g in 1 TUBE | CREAM | 15 | 103 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-8778-1 | GM - Gram | 63629-8778 | 8067a66e-0d32-4812-8693-fef195321ab2 | 1 | 2021-10-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-8778 | TRIAMCINOLONE ACETONIDE CREAM [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 1 package rows | 20240823_0bf47993-615c-4d89-8e02-145f59315362.zip |
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 |
|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | d0428b54-c4f5-46f1-a65e-7e20c56dbe78 | 2025-07-10 | Adverse reactions | 088042 ANDA088042 |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | a7c85d92-734e-4175-b1a7-eaff97abc45c | 2024-11-12 | Adverse reactions | 088042 ANDA088042 |
| Scarzen | TRIAMCINOLONE ACETONIDE, DIMETHICONE | Village Pharma LLC | 4777b129-5f7e-49af-9cf7-65158fdf4348 | 2024-11-01 | Warnings, Adverse reactions | 088042 ANDA088042 |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | 0bf47993-615c-4d89-8e02-145f59315362 | 2024-08-14 | Adverse reactions | 088042 ANDA088042 63629-8778 |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | NuCare Pharmaceuticals,Inc. | b43d4e4a-6206-4449-e053-2a95a90a721a | 2024-07-17 | Adverse reactions | 088042 ANDA088042 |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | 7889440c-4e82-4eb2-b5d3-7c4e0d5bdd8d | 2024-02-20 | Adverse reactions | 088042 ANDA088042 |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | ad88de0e-6e01-4056-b259-841fb67d2db0 | 2023-10-30 | Adverse reactions | 088042 ANDA088042 |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Bryant Ranch Prepack | 70116d71-97a9-4a9b-bf1d-e79c8ef596e2 | 2023-08-04 | Adverse reactions | 088042 ANDA088042 |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Proficient Rx LP | 7dc12943-7702-4c84-b507-2ea207d02460 | 2023-06-01 | Adverse reactions | 088042 ANDA088042 |
| Triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Proficient Rx LP | 7a2392c6-d26f-4def-8c7d-8b79e384c522 | 2022-10-01 | Adverse reactions | 088042 ANDA088042 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014314 | triamcinolone acetonide 0.1 % Topical Cream | PSN | 0bf47993-615c-4d89-8e02-145f59315362 | 103 |
| 1014314 | triamcinolone acetonide 1 MG/ML Topical Cream | SCD | 0bf47993-615c-4d89-8e02-145f59315362 | 103 |
| 1014314 | triamcinolone acetonide 0.1 % Topical Cream | SY | 0bf47993-615c-4d89-8e02-145f59315362 | 103 |
| 1014314 | triamcinolone acetonide 1 MG per GM Topical Cream | SY | 0bf47993-615c-4d89-8e02-145f59315362 | 103 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-8778-1 | 63629877801 | 15 g in 1 TUBE (63629-8778-1) | 15 g | 2021-08-31 | 0000-00-00 | No | No | Current |