KENALOG-40
- Product NDC
- 63187-661
- Requested package NDC
- 63187-661-01
- 11-digit product format
- 631870661
- Labeler code
- 63187
- Product ID
- 63187-661_6ea8b135-ac8a-4a01-9b3e-0440562af45c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRIAMCINOLONE ACETONIDE
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRAMUSCULAR
- Labeler
- Proficient Rx LP
- Application
- NDA014901
- Marketing category
- NDA
- Marketing start
- 2009-06-01
- Substance
- TRIAMCINOLONE ACETONIDE
- Active strength
- 40 mg/mL
- 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 |
|---|---|---|---|---|---|---|---|
| N014901-001 | KENALOG-40 | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | |
| N014901-002 | KENALOG-80 | TRIAMCINOLONE ACETONIDE | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N014901-001 | AB |
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 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N014901-001 | KENALOG-40 | 40MG/ML | INJECTABLE / INJECTION | AB | RLD, RS, Approved before 1982 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N014901-002 | KENALOG-80 | 80MG/ML | INJECTABLE / INJECTION | RLD, RS | 2019-04-12 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N014901-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N014901-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N014901-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N014901-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N014901-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N014901-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N014901-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N014901-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N014901-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N014901-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N014901-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N014901-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N014901-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N014901-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N014901-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N014901-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N014901-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N014901-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N014901-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N014901-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N014901-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N014901-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N014901-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N014901-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N014901-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N014901-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N014901-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N014901-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N014901-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N014901-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N014901-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N014901-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N014901-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N014901-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N014901-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N014901-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N014901-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N014901-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N014901-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N014901-001 | AB | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KENALOG-40
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRIAMCINOLONE ACETONIDE | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F446C597KA | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1ed85825-cd03-4b5b-9c9a-946653b5f71a | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63187-661-01 | 2023-02-04 | C162847 | 48780-1 | f386c649-fdd5-0266-e053-dadaa90a7c1a | KENALOG ® -40 INJECTION (triamcinolone acetonide injectable suspension, USP) |
| 63187-661-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-fdd5-0266-e053-dadaa90a7c1a | KENALOG ® -40 INJECTION (triamcinolone acetonide injectable suspension, USP) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63187-661-01 | KENALOG-40 | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 1 | 5 | |
| 63187-661-01 | KENALOG-40 | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-661-01 | ML - Milliliter | 63187-661 | ff7e24d2-0644-45af-86d3-021d6e111026 | 1 | 2025-05-14 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | 4ce116aa-b330-4da9-9cdd-ba8e6be0c4ad | 2026-01-05 | Warnings, Adverse reactions | 014901 NDA014901 |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | d26b97b8-edc8-4b93-b6b9-429016208ff9 | 2025-12-05 | Warnings, Adverse reactions | 014901 NDA014901 |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | E.R. Squibb & Sons, L.L.C. | cf970688-cd77-b95c-4bd9-c541590e9722 | 2024-08-20 | Warnings, Adverse reactions | 014901 NDA014901 |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | A-S Medication Solutions | cb0480b8-44ee-4506-b484-dc776c3092dc | 2023-06-15 | Warnings, Adverse reactions | 014901 NDA014901 |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | Proficient Rx LP | 1ed85825-cd03-4b5b-9c9a-946653b5f71a | 2023-01-01 | Warnings, Adverse reactions | 014901 NDA014901 63187-661-01 63187-661 63187066101 |
| KENALOG-40 | TRIAMCINOLONE ACETONIDE | Asclemed USA, Inc. | 0bc9c75f-963c-40b0-995b-dfcbd50371a5 | 2020-05-06 | Warnings, Adverse reactions | 014901 NDA014901 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1085756 | Kenalog 40 MG/ML Injectable Suspension | PSN | 1ed85825-cd03-4b5b-9c9a-946653b5f71a | 5 |
| 1085754 | triamcinolone acetonide 40 MG/ML Injectable Suspension | PSN | 1ed85825-cd03-4b5b-9c9a-946653b5f71a | 5 |
| 1085756 | triamcinolone acetonide 40 MG/ML Injectable Suspension [Kenalog] | SBD | 1ed85825-cd03-4b5b-9c9a-946653b5f71a | 5 |
| 1085754 | triamcinolone acetonide 40 MG/ML Injectable Suspension | SCD | 1ed85825-cd03-4b5b-9c9a-946653b5f71a | 5 |
| 1085756 | Kenalog 40 MG/ML Injectable Suspension | SY | 1ed85825-cd03-4b5b-9c9a-946653b5f71a | 5 |
| 1085756 | Kenalog-40 40 MG/ML Injectable Suspension | SY | 1ed85825-cd03-4b5b-9c9a-946653b5f71a | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63187-661-01 | 63187066101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63187-661-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2018-12-01 | 0000-00-00 | No | No | Current |