FDA.reportPublic FDA data

GLYCOPHOS

Product NDC
65219-346
11-digit product format
652190346
Labeler code
65219
Product ID
65219-346_05761514-5960-44b8-8e1d-7f0a1ceeee2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Glycerophosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA220381
Marketing category
NDA
Marketing start
2026-07-29
Substance
SODIUM GLYCEROPHOSPHATE ANHYDROUS
Active strength
216 mg/mL
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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220381-001GLYCOPHOSSODIUM GLYCEROPHOSPHATE4.32GM/20ML (216MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-29
N220381-002GLYCOPHOSSODIUM GLYCEROPHOSPHATE21.6GM/100ML (216MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N220381-001GLYCOPHOS4.32GM/20ML (216MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-29c2088c7a36db…
2026-10-15 13:18:302026-09N220381-002GLYCOPHOS21.6GM/100ML (216MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-29c2088c7a36db…
2026-09-14 22:38:342026-08N220381-001GLYCOPHOS4.32GM/20ML (216MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-2984e616aacf4f…
2026-09-14 22:38:342026-08N220381-002GLYCOPHOS21.6GM/100ML (216MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-2984e616aacf4f…
2026-08-18 06:07:402026-07N220381-001GLYCOPHOS4.32GM/20ML (216MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-29caaa826d4ba7…
2026-08-18 06:07:402026-07N220381-002GLYCOPHOS21.6GM/100ML (216MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-29caaa826d4ba7…

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
GLYCOPHOS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM GLYCEROPHOSPHATE ANHYDROUS216 mg/mL

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65219-346-206521903462025 VIAL, SINGLE-DOSE in 1 CARTON (65219-346-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-346-01) 2026-07-29NoNoCurrent