triamcinolone acetonide
- Product NDC
- 35356-658
- 11-digit product format
- 353560658
- Labeler code
- 35356
- Product ID
- 35356-658_a7ce6ebd-c0ef-40b5-ae45-03975d3598a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- triamcinolone acetonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
- Application
- ANDA085692
- Marketing category
- ANDA
- Marketing start
- 1978-03-09
- Marketing end
- 0000-00-00
- Substance
- TRIAMCINOLONE ACETONIDE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 | 35356-658 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 35356-658 | 35356-658-80 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 35356-658 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | ||
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 35356-658 | 35356-658-80 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 35356-658 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | ||
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 35356-658 | 35356-658-80 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A085692-001 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | |
| A085692-002 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | |
| A085692-003 | TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A085692-001 | AT |
| A085692-002 | AT |
| A085692-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085692-002 | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085692-003 | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A085692-001 | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM / TOPICAL | AT | RLD, RS, Approved before 1982 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A085692-001 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085692-002 | AT | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A085692-003 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-001 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-002 | AT | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085692-003 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-001 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-002 | AT | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A085692-003 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-001 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-002 | AT | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085692-003 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-001 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-002 | AT | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085692-003 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-001 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-002 | AT | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085692-003 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-001 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-002 | AT | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085692-003 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-002 | AT | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085692-003 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-001 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-002 | AT | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085692-003 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-001 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-002 | AT | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A085692-003 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-001 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-002 | AT | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085692-003 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-001 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-002 | AT | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085692-003 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085692-001 | AT | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085692-002 | AT | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085692-003 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A085692-001 | AT | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | DIRECTRX | 835bbcd1-3869-646c-e053-2a91aa0a796a | 2026-03-17 | Adverse reactions | 085692 ANDA085692 |
| triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 92a1ded0-8e1a-4994-9c8a-89e84fc85c94 | 2026-01-28 | Adverse reactions | 085692 ANDA085692 |
| triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | 5701a07f-bd22-4bc7-95ff-0c5444ea5971 | 2025-10-01 | Adverse reactions | 085692 ANDA085692 |
| triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | Preferred Pharmaceuticals Inc. | 5040eba2-2d00-496a-8773-66ba5440610f | 2025-06-27 | Adverse reactions | 085692 ANDA085692 |
| triamcinolone acetonide | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | 2d6b9c2f-f1a0-413e-b333-64da52368202 | 2023-12-09 | Adverse reactions | 085692 ANDA085692 |
| Triamcinolone Acetonide | TRIAMCINOLONE ACETONIDE | Proficient Rx LP | 41c1fe93-0509-4cf6-ac35-049028b731de | 2019-12-01 | Adverse reactions | 085692 ANDA085692 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 35356-658-80 | GM - Gram | 35356-658 | 6d910a6a-d402-42f2-a87c-6ecf2b139dfd | 1 | 2013-02-13 |