ascorbic acid

Generic: ascorbic acid

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ascorbic acid
Generic Name ascorbic acid
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ascorbic acid 500 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-027
Product ID 65219-027_d6fd1a37-70e1-477a-afc9-4977a54c7b75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217131
Listing Expiration 2026-12-31
Marketing Start 2025-12-08

Pharmacologic Class

Established (EPC)
vitamin c [epc]
Chemical Structure
ascorbic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219027
Hyphenated Format 65219-027

Supplemental Identifiers

RxCUI
308395
UPC
0365219027553 0365219027058
UNII
PQ6CK8PD0R
NUI
N0000193618 M0001797

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 ascorbic acid (source: ndc)
Generic Name ascorbic acid (source: ndc)
Application Number ANDA217131 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/mL
source: ndc
Packaging
  • 25 VIAL, GLASS in 1 TRAY (65219-027-50) / 50 mL in 1 VIAL, GLASS (65219-027-05)
  • 1 VIAL, GLASS in 1 CARTON (65219-027-55) / 50 mL in 1 VIAL, GLASS
source: ndc

Packages (2)

65219-027-50 25 VIAL, GLASS in 1 TRAY (65219-027-50) / 50 mL in 1 VIAL, GLASS (65219-027-05) 65219-027-55 1 VIAL, GLASS in 1 CARTON (65219-027-55) / 50 mL in 1 VIAL, GLASS

Ingredients (1)

ascorbic acid (500 mg/mL)

Linked Drug Pages (1)

Ascorbic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d6fd1a37-70e1-477a-afc9-4977a54c7b75", "openfda": {"nui": ["N0000193618", "M0001797"], "upc": ["0365219027553", "0365219027058"], "unii": ["PQ6CK8PD0R"], "rxcui": ["308395"], "spl_set_id": ["1606e29f-0e80-4069-b688-daab9cbff20a"], "pharm_class_cs": ["Ascorbic Acid [CS]"], "pharm_class_epc": ["Vitamin C [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, GLASS in 1 TRAY (65219-027-50)  / 50 mL in 1 VIAL, GLASS (65219-027-05)", "package_ndc": "65219-027-50", "marketing_start_date": "20251208"}, {"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (65219-027-55)  / 50 mL in 1 VIAL, GLASS", "package_ndc": "65219-027-55", "marketing_start_date": "20251208"}], "brand_name": "Ascorbic Acid", "product_id": "65219-027_d6fd1a37-70e1-477a-afc9-4977a54c7b75", "dosage_form": "INJECTION", "pharm_class": ["Ascorbic Acid [CS]", "Vitamin C [EPC]"], "product_ndc": "65219-027", "generic_name": "Ascorbic Acid", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ascorbic Acid", "active_ingredients": [{"name": "ASCORBIC ACID", "strength": "500 mg/mL"}], "application_number": "ANDA217131", "marketing_category": "ANDA", "marketing_start_date": "20251208", "listing_expiration_date": "20261231"}