FDA.reportPublic FDA data

AS-3

Product NDC
87069-460
Requested package NDC
87069-460-42
11-digit product format
870690460
Labeler code
87069
Product ID
87069-460_42ecbc27-e538-a151-e063-6394a90ad89e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AS-3
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
GVS TM INC
Application
BN820915
Marketing category
NDA
Marketing start
2025-09-15
Substance
ADENINE; DEXTROSE, UNSPECIFIED FORM
Active strength
.03; 1 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AS-3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADENINE.03 g/100mL
DEXTROSE, UNSPECIFIED FORM1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IY9XDZ35W2Internal UNII lookup
JAC85A2161Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3dfa3397-fc13-4659-e063-6394a90a5abcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87069-460-42AS-324 in 1 CARTONSOLUTION242
87069-460-42AS-3250 mL in 1 BAGSOLUTION2502

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leukotrap WB system - CP2DCP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC42ece7e1-1da1-7e5a-e063-6294a90ac8032026-07-03Exact identifier
application number: BN820915
Blood Collection SystemCP2D/AS-3 TRIPLE WITH SAMPLING SYSTEMGVS TM INC54e8cfd2-f91b-8381-e063-6394a90a3f772026-06-23Exact identifier
application number: BN820915
Leukotrap RC PL SystemCPD2/AS-3 TRIPLE BLOOD BAG WITH IN LINE RCM1 AND ATS-LPL FILTERS AND SAMPLING SYSTEMGVS TM INC54eab581-bc48-f9f0-e063-6394a90a4b932026-06-23Exact identifier
application number: BN820915
Leukotrap RC SystemCP2D/AS-3 TRIPLE BLOOD BAG UNIT WITH IN-LINE RC2D FILTER AND SAMPLING SYSTEMGVS TM INC4c0dec79-1648-1cfd-e063-6394a90a88cc2026-06-01Exact identifier
application number: BN820915
Leukotrap WB System - CP2DCP2S/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC44a7d200-13cb-c0b0-e063-6294a90aafad2025-11-28Exact identifier
application number: BN820915
Leukotrap WB System - CP2DCP2S/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEMGVS TM INC44a82ea8-69bf-f061-e063-6394a90af3da2025-11-28Exact identifier
application number: BN820915
AS-3AS-3GVS TM INC3dfa3397-fc13-4659-e063-6394a90a5abc2025-11-06WarningsExact identifier
application number: BN820915
ndc (package): 87069-460-42
ndc (product): 87069-460
ndc11 (package): 87069046042
CP2DCP2DGVS TM INC3fa2e438-2ff0-a2df-e063-6394a90ac7b52025-11-06WarningsExact identifier
application number: BN820915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87069-460-428706904604224 BAG in 1 CARTON (87069-460-42) / 250 mL in 1 BAG24 bag2025-09-15NoNoCurrent