foscarnet sodium

Generic: foscarnet sodium

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name foscarnet sodium
Generic Name foscarnet sodium
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

foscarnet sodium 24 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-389
Product ID 68083-389_e7d4415b-96cc-4f7b-b639-7369baf4871a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213001
Listing Expiration 2026-12-31
Marketing Start 2021-04-21

Pharmacologic Class

Classes
chelating activity [moa] dna polymerase inhibitors [moa] pyrophosphate analog dna polymerase inhibitor [epc] pyrophosphate analog [ext]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083389
Hyphenated Format 68083-389

Supplemental Identifiers

RxCUI
1734377
UPC
0368083389017
UNII
964YS0OOG1

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 foscarnet sodium (source: ndc)
Generic Name foscarnet sodium (source: ndc)
Application Number ANDA213001 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 24 mg/mL
source: ndc
Packaging
  • 1 BAG in 1 CARTON (68083-389-01) / 250 mL in 1 BAG
source: ndc

Packages (1)

68083-389-01 1 BAG in 1 CARTON (68083-389-01) / 250 mL in 1 BAG

Ingredients (1)

foscarnet sodium (24 mg/mL)

Linked Drug Pages (1)

Foscarnet Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e7d4415b-96cc-4f7b-b639-7369baf4871a", "openfda": {"upc": ["0368083389017"], "unii": ["964YS0OOG1"], "rxcui": ["1734377"], "spl_set_id": ["d4048736-389f-48d8-aadd-6bc76d604ddb"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 CARTON (68083-389-01)  / 250 mL in 1 BAG", "package_ndc": "68083-389-01", "marketing_start_date": "20210421"}], "brand_name": "Foscarnet Sodium", "product_id": "68083-389_e7d4415b-96cc-4f7b-b639-7369baf4871a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Chelating Activity [MoA]", "DNA Polymerase Inhibitors [MoA]", "Pyrophosphate Analog DNA Polymerase Inhibitor [EPC]", "Pyrophosphate Analog [EXT]"], "product_ndc": "68083-389", "generic_name": "Foscarnet Sodium", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Foscarnet Sodium", "active_ingredients": [{"name": "FOSCARNET SODIUM", "strength": "24 mg/mL"}], "application_number": "ANDA213001", "marketing_category": "ANDA", "marketing_start_date": "20210421", "listing_expiration_date": "20261231"}