mardex 25 kit

Generic: dexamethasone sodium phosphate, bupivacaine hydrochloride, povidine iodine

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name mardex 25 kit
Generic Name dexamethasone sodium phosphate, bupivacaine hydrochloride, povidine iodine
Labeler asclemed usa, inc.
Dosage Form KIT
Routes
EPIDURAL INFILTRATION INTRAMUSCULAR INTRAVENOUS TOPICAL
Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-810
Product ID 76420-810_47db0a49-753e-2eb3-e063-6294a90ab279
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2027-12-31
Marketing Start 2014-08-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420810
Hyphenated Format 76420-810

Supplemental Identifiers

RxCUI
797544 797730 1725078 1725082 1812079

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 mardex 25 kit (source: ndc)
Generic Name dexamethasone sodium phosphate, bupivacaine hydrochloride, povidine iodine (source: ndc)
Routes
EPIDURAL INFILTRATION INTRAMUSCULAR INTRAVENOUS TOPICAL
source: ndc

Resolved Composition

Strengths
  • 0.25 %
  • 25 mg/10 ml
  • 2.5 mg/ml
  • 75 mg/30 ml
  • 125 mg/50 ml
  • 0.5 %
  • 50 mg/10 ml
  • 5 mg/ml
  • 150 mg/30 ml
  • 250 mg/50 ml
  • 0.75 %
  • 75 mg/10 ml
  • 7.5 mg/ml
  • 225 mg/30 ml
  • 10 mg
  • 10 mg/ml
  • 1 ml
  • 10 %
  • 9.85 %
  • 70 %
source: label
Packaging
  • 1 KIT in 1 CARTON (76420-810-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL
source: ndc

Packages (1)

76420-810-01 1 KIT in 1 CARTON (76420-810-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Mardex 25 Kit ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INFILTRATION", "INTRAMUSCULAR", "INTRAVENOUS", "TOPICAL"], "spl_id": "47db0a49-753e-2eb3-e063-6294a90ab279", "openfda": {"rxcui": ["797544", "797730", "1725078", "1725082", "1812079"], "spl_set_id": ["94472ddb-ae1d-4a11-a673-81254d562e6b"], "manufacturer_name": ["Asclemed USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (76420-810-01)  *  10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18)  *  .9 mL in 1 PACKET (67777-419-02)  *  5 mL in 1 POUCH *  25 VIAL in 1 TRAY (63323-506-01)  / 1 mL in 1 VIAL", "package_ndc": "76420-810-01", "marketing_start_date": "20140821"}], "brand_name": "Mardex 25 Kit", "product_id": "76420-810_47db0a49-753e-2eb3-e063-6294a90ab279", "dosage_form": "KIT", "product_ndc": "76420-810", "generic_name": "Dexamethasone Sodium Phosphate, Bupivacaine Hydrochloride, Povidine Iodine", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mardex 25 Kit", "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20140821", "listing_expiration_date": "20271231"}