zilretta

Generic: triamcinolone acetonide extended-release injectable suspension

Labeler: pacira pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zilretta
Generic Name triamcinolone acetonide extended-release injectable suspension
Labeler pacira pharmaceuticals, inc.
Dosage Form KIT
Routes
INTRA-ARTICULAR
Manufacturer
Pacira Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 65250-003
Product ID 65250-003_f5c73a99-9cc3-49f2-abaf-bbabfc33ba06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208845
Listing Expiration 2026-12-31
Marketing Start 2017-10-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65250003
Hyphenated Format 65250-003

Supplemental Identifiers

RxCUI
1947131 1947133

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 zilretta (source: ndc)
Generic Name triamcinolone acetonide extended-release injectable suspension (source: ndc)
Application Number NDA208845 (source: ndc)
Routes
INTRA-ARTICULAR
source: ndc

Resolved Composition

Strengths
  • 32 mg
  • 5 ml
  • 0.9 %
  • 0.5 %
  • 0.1 %
source: label
Packaging
  • 1 KIT in 1 CARTON (65250-003-01) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (65250-001-01) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (65250-002-01)
source: ndc

Packages (1)

65250-003-01 1 KIT in 1 CARTON (65250-003-01) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (65250-001-01) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (65250-002-01)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Zilretta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTICULAR"], "spl_id": "f5c73a99-9cc3-49f2-abaf-bbabfc33ba06", "openfda": {"rxcui": ["1947131", "1947133"], "spl_set_id": ["cd5c4673-21f2-4126-9556-da847b3a228b"], "manufacturer_name": ["Pacira Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (65250-003-01)  *  1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (65250-001-01)  *  1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (65250-002-01)", "package_ndc": "65250-003-01", "marketing_start_date": "20171006"}], "brand_name": "Zilretta", "product_id": "65250-003_f5c73a99-9cc3-49f2-abaf-bbabfc33ba06", "dosage_form": "KIT", "product_ndc": "65250-003", "generic_name": "triamcinolone acetonide extended-release injectable suspension", "labeler_name": "Pacira Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zilretta", "application_number": "NDA208845", "marketing_category": "NDA", "marketing_start_date": "20171006", "listing_expiration_date": "20261231"}