KENALOG-80
- Product NDC
- 0003-0315
- 11-digit product format
- 000030315
- Labeler code
- 0003
- Product ID
- 0003-0315_721dbcb3-df3b-428c-a5e6-1c807025a14a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRIAMCINOLONE ACETONIDE
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRAMUSCULAR
- Labeler
- E.R. Squibb & Sons, L.L.C.
- Application
- NDA014901
- Marketing category
- NDA
- Marketing start
- 2019-04-12
- Substance
- TRIAMCINOLONE ACETONIDE
- Active strength
- 80 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KENALOG-80
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRIAMCINOLONE ACETONIDE | 80 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F446C597KA |
| Rxcui | 1085754, 1085756, 1792144, 2168081, 2168083, 2168095, 2168097, 2480108 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0003-0315-05 | KENALOG-80 | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 1 | | 24 |
| 0003-0315-05 | KENALOG-80 | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 24 |
| 0003-0315-20 | KENALOG-80 | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 5 | | 24 |
| 0003-0315-20 | KENALOG-80 | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| triamcinolone acetonide | ACTIVE INGREDIENT | F446C597KA | KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [E.R. SQUIBB & SONS, L.L.C.] | 11 | |
| TRIAMCINOLONE ACETONIDE | ACTIVE MOIETY | F446C597KA | KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [E.R. SQUIBB & SONS, L.L.C.] | 11 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [E.R. SQUIBB & SONS, L.L.C.] | 11 | |
| carboxymethylcellulose sodium | INACTIVE INGREDIENT | K679OBS311 | KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [E.R. SQUIBB & SONS, L.L.C.] | 11 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [E.R. SQUIBB & SONS, L.L.C.] | 11 | |
| nitrogen | INACTIVE INGREDIENT | N762921K75 | KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [E.R. SQUIBB & SONS, L.L.C.] | 11 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [E.R. SQUIBB & SONS, L.L.C.] | 11 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [E.R. SQUIBB & SONS, L.L.C.] | 11 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [E.R. SQUIBB & SONS, L.L.C.] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0003-0315 | KENALOG-40 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION KENALOG-80 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [E.R. SQUIBB & SONS, L.L.C.] | 24 | Current NDC, Legacy NDC, 4 package rows | 20240823_cf970688-cd77-b95c-4bd9-c541590e9722.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0003-0315-05 | 00003031505 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-0315-05) / 1 mL in 1 VIAL, SINGLE-DOSE | 2019-04-12 | 0000-00-00 | No | No | Current |
| 0003-0315-20 | 00003031520 | 1 VIAL, MULTI-DOSE in 1 CARTON (0003-0315-20) / 5 mL in 1 VIAL, MULTI-DOSE | 2019-04-12 | 0000-00-00 | No | No | Current |