Home NDC 69499-501 QUIOFIC
Product NDC 69499-501
11-digit product format 694990501
Labeler code 69499
Product ID 69499-501_2df4e376-7829-44c9-9cd4-70cd980046a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name folic acid
Dosage form SOLUTION
Route ORAL
Labeler Solubiomix, LLC
Application NDA216395
Marketing category NDA
Marketing start 2026-01-28
Substance FOLIC ACID
Active strength 1 mg/5mL
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 N216395-001 QUIOFIC FOLIC ACID 0.2MG/ML SOLUTION / ORAL RLD, RS 2026-01-26
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 N216395-001 QUIOFIC 0.2MG/ML SOLUTION / ORAL RLD, RS 2026-01-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216395-001 QUIOFIC 0.2MG/ML SOLUTION / ORAL RLD, RS 2026-01-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216395-001 QUIOFIC 0.2MG/ML SOLUTION / ORAL RLD, RS 2026-01-26 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216395-001 QUIOFIC 0.2MG/ML SOLUTION / ORAL RLD, RS 2026-01-26 a50c72e98297…
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 QUIOFIC
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOLIC ACID 1 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 935E97BOY8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2707361 Internal RxNorm lookup 2733998 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69499-501-75 QUIOFIC 75 mL in 1 BOTTLE SOLUTION 75 3
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69499-501-75 69499050175 75 mL in 1 BOTTLE (69499-501-75) 75 ml 2026-01-28 No No Current