triamcinolone acetonide

Generic: triamcinolone acetonide

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name triamcinolone acetonide
Generic Name triamcinolone acetonide
Labeler alembic pharmaceuticals limited
Dosage Form INJECTION, SUSPENSION
Routes
INTRA-ARTICULAR INTRAMUSCULAR
Active Ingredients

triamcinolone acetonide 40 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-812
Product ID 46708-812_c0b487dd-a47b-42fd-a855-5d237c5651a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218601
Listing Expiration 2026-12-31
Marketing Start 2025-10-17

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 46708812
Hyphenated Format 46708-812

Supplemental Identifiers

RxCUI
1085754 1792144
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 triamcinolone acetonide (source: ndc)
Generic Name triamcinolone acetonide (source: ndc)
Application Number ANDA218601 (source: ndc)
Routes
INTRA-ARTICULAR INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-812-01) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (46708-812-25) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

46708-812-01 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-812-01) / 1 mL in 1 VIAL, SINGLE-DOSE 46708-812-25 25 VIAL, SINGLE-DOSE in 1 CARTON (46708-812-25) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

triamcinolone acetonide (40 mg/mL)

Linked Drug Pages (1)

Triamcinolone Acetonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTICULAR", "INTRAMUSCULAR"], "spl_id": "c0b487dd-a47b-42fd-a855-5d237c5651a9", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["F446C597KA"], "rxcui": ["1085754", "1792144"], "spl_set_id": ["c0b487dd-a47b-42fd-a855-5d237c5651a9"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (46708-812-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "46708-812-01", "marketing_start_date": "20251017"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (46708-812-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "46708-812-25", "marketing_start_date": "20251017"}], "brand_name": "Triamcinolone Acetonide", "product_id": "46708-812_c0b487dd-a47b-42fd-a855-5d237c5651a9", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "46708-812", "generic_name": "Triamcinolone Acetonide", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Triamcinolone Acetonide", "active_ingredients": [{"name": "TRIAMCINOLONE ACETONIDE", "strength": "40 mg/mL"}], "application_number": "ANDA218601", "marketing_category": "ANDA", "marketing_start_date": "20251017", "listing_expiration_date": "20261231"}