Home NDC 84897-058 Ascorbic Acid
Product NDC 84897-058
11-digit product format 848970058
Labeler code 84897
Product ID 84897-058_42402cfd-6731-4648-8e25-6f92209d4e1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ascorbic Acid
Dosage form INJECTION
Route INTRAVENOUS
Labeler Renova Pharmaceuticals LLC
Application ANDA220172
Marketing category ANDA
Marketing start 2026-08-08
Substance ASCORBIC ACID
Active strength 500 mg/mL
Pharmacologic classes Ascorbic Acid [CS], Vitamin C [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220172-001 ASCORBIC ACID ASCORBIC ACID 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP 2026-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220172-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A220172-001 ASCORBIC ACID 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP 2026-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220172-001 ASCORBIC ACID 25,000MG/50ML (500MG/ML) SOLUTION / INTRAVENOUS AP 2026-07-30 caaa826d4ba7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A220172-001 AP 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220172-001 AP 1 caaa826d4ba7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ascorbic Acid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASCORBIC ACID 500 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PQ6CK8PD0R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308395 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84897-058-01 84897005801 1 VIAL, GLASS in 1 CARTON (84897-058-01) / 50 mL in 1 VIAL, GLASS 2026-08-08 No No Current 84897-058-25 84897005825 25 VIAL, GLASS in 1 TRAY (84897-058-25) / 50 mL in 1 VIAL, GLASS 2026-08-08 No No Current