Home NDC 65219-502-10 Sodium chloride
Product NDC 65219-502
Requested package NDC 65219-502-10
11-digit product format 652190502
Labeler code 65219
Product ID 65219-502_53843388-e3bc-4344-87aa-b345680ec27b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM CHLORIDE
Dosage form INJECTION, SOLUTION
Route IRRIGATION
Labeler Fresenius Kabi USA, LLC
Application ANDA213688
Marketing category ANDA
Marketing start 2025-12-19
Substance SODIUM CHLORIDE
Active strength .9 g/100mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213688-001 AT
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 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213688-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML SOLUTION / IRRIGATION AT 2024-06-24 a50c72e98297…
Observed Orange Book normalized TE history# 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 Sodium chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CHLORIDE .9 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 451W47IQ8X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 486515 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 65219-502-01 Sodium chloride 1000 mL in 1 BAG INJECTION, SOLUTION 1000 6 65219-502-10 Sodium chloride 6 in 1 CASE INJECTION, SOLUTION 6 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-502 SODIUM CHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, 2 package rows 20250402_ce0c8c6f-734a-400f-9b60-a3b1e263f25f.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65219-502-10 65219050210 6 BAG in 1 CASE (65219-502-10) / 1000 mL in 1 BAG (65219-502-01) 6 bag 2025-12-19 No No Current