Home NDC 63323-099 Sodium Chloride
Product NDC 63323-099
11-digit product format 633230099
Labeler code 63323
Product ID 63323-099_f5197532-af45-42c9-919b-30d00276650e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Chloride
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA217796
Marketing category ANDA
Marketing start 2023-07-11
Substance SODIUM CHLORIDE
Active strength 4 meq/mL
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 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 A217796-001 SODIUM CHLORIDE 23.4% SODIUM CHLORIDE 234MG/ML INJECTABLE / INJECTION AP 2023-07-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217796-001 AP
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 2026-02-19 14:30 UTC 2026-02 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217796-001 SODIUM CHLORIDE 23.4% 234MG/ML INJECTABLE / INJECTION AP 2023-07-11 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217796-001 CGT 2024-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217796-001 CGT 2024-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217796-001 CGT 2024-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217796-001 CGT 2024-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217796-001 CGT 2024-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217796-001 CGT 2024-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217796-001 CGT 2024-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217796-001 CGT 2024-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217796-001 CGT 2024-01-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217796-001 CGT 2024-01-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217796-001 CGT 2024-01-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217796-001 CGT 2024-01-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217796-001 CGT 2024-01-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217796-001 CGT 2024-01-23 9b2671bbb829…
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 4 meq/mL
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 313016 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 63323-099-03 Sodium Chloride 200 mL in 1 VIAL, PLASTIC INJECTION, SOLUTION, CONCENTRATE 200 1 63323-099-63 Sodium Chloride 10 in 1 TRAY INJECTION, SOLUTION, CONCENTRATE 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-099 SODIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC] 1 Current NDC, 2 package rows 20230720_b6e33138-841a-471f-a934-c4086cbc23f6.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 · 1 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 63323-099-03 63323009903 200 mL in 1 VIAL, PLASTIC 200 ml Historical 63323-099-63 63323009963 10 VIAL, PLASTIC in 1 TRAY (63323-099-63) / 200 mL in 1 VIAL, PLASTIC (63323-099-03) 2023-07-11 No No Current