kenalog-80

Generic: triamcinolone acetonide

Labeler: e.r. squibb & sons, l.l.c.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kenalog-80
Generic Name triamcinolone acetonide
Labeler e.r. squibb & sons, l.l.c.
Dosage Form INJECTION, SUSPENSION
Routes
INTRA-ARTICULAR INTRAMUSCULAR
Active Ingredients

triamcinolone acetonide 80 mg/mL

Manufacturer
E.R. Squibb & Sons, L.L.C.

Identifiers & Regulatory

Product NDC 0003-0315
Product ID 0003-0315_721dbcb3-df3b-428c-a5e6-1c807025a14a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA014901
Listing Expiration 2026-12-31
Marketing Start 2019-04-12

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00030315
Hyphenated Format 0003-0315

Supplemental Identifiers

RxCUI
1085754 1085756 1792144 2168081 2168083 2168095 2168097 2480108
UNII
F446C597KA
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kenalog-80 (source: ndc)
Generic Name triamcinolone acetonide (source: ndc)
Application Number NDA014901 (source: ndc)
Routes
INTRA-ARTICULAR INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-0315-05) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0003-0315-20) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

0003-0315-05 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-0315-05) / 1 mL in 1 VIAL, SINGLE-DOSE 0003-0315-20 1 VIAL, MULTI-DOSE in 1 CARTON (0003-0315-20) / 5 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

triamcinolone acetonide (80 mg/mL)

Linked Drug Pages (1)

KENALOG-40, KENALOG-80 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTICULAR", "INTRAMUSCULAR"], "spl_id": "721dbcb3-df3b-428c-a5e6-1c807025a14a", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["F446C597KA"], "rxcui": ["1085754", "1085756", "1792144", "2168081", "2168083", "2168095", "2168097", "2480108"], "spl_set_id": ["cf970688-cd77-b95c-4bd9-c541590e9722"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["E.R. Squibb & Sons, L.L.C."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0003-0315-05)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0003-0315-05", "marketing_start_date": "20190412"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0003-0315-20)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0003-0315-20", "marketing_start_date": "20190412"}], "brand_name": "KENALOG-80", "product_id": "0003-0315_721dbcb3-df3b-428c-a5e6-1c807025a14a", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0003-0315", "generic_name": "TRIAMCINOLONE ACETONIDE", "labeler_name": "E.R. Squibb & Sons, L.L.C.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KENALOG-80", "active_ingredients": [{"name": "TRIAMCINOLONE ACETONIDE", "strength": "80 mg/mL"}], "application_number": "NDA014901", "marketing_category": "NDA", "marketing_start_date": "20190412", "listing_expiration_date": "20261231"}