Home NDC 0338-0295 Sorbitol
Product NDC 0338-0295
11-digit product format 003380295
Labeler code 0338
Product ID 0338-0295_45450c96-48fb-457b-bd3d-db242c848474
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sorbitol
Dosage form IRRIGANT
Route IRRIGATION
Labeler Baxter Healthcare Corporation
Application NDA017863
Marketing category NDA
Marketing start 1980-05-30
Substance SORBITOL
Active strength 30 g/1000mL
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 1 .
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 N017863-001 SORBITOL 3% IN PLASTIC CONTAINER SORBITOL 3GM/100ML SOLUTION / IRRIGATION Approved before 1982
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 2026-08-01 22:54:32 2026-06 N017863-001 SORBITOL 3% IN PLASTIC CONTAINER 3GM/100ML SOLUTION / IRRIGATION Approved before 1982 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Sorbitol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SORBITOL 30 g/1000mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 506T60A25R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313090 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-0295-47 Sorbitol 3000 mL in 1 BAG IRRIGANT 3000 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0295 SORBITOL IRRIGANT [BAXTER HEALTHCARE CORPORATION] 10 Current NDC, Legacy NDC, 1 package rows 20250519_aea0b5a1-444b-4330-a3ce-26485dbbfe75.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0338-0295-47 00338029547 3000 mL in 1 BAG (0338-0295-47) 3000 ml 1980-05-30 0000-00-00 No No Current