Home NDC 63323-090 Sodium Chloride
Product NDC 63323-090
11-digit product format 633230090
Labeler code 63323
Product ID 63323-090_eb8f5fdb-b8da-4d67-a5e0-b2479bf38170
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Chloride
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA212070
Marketing category ANDA
Marketing start 2021-04-28
Substance SODIUM CHLORIDE
Active strength 2.5 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212070-001 SODIUM CHLORIDE 14.6% SODIUM CHLORIDE 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 A212070-002 SODIUM CHLORIDE 14.6% SODIUM CHLORIDE 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 A212070-003 SODIUM CHLORIDE 23.4% SODIUM CHLORIDE 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 97 observed 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 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212070-002 SODIUM CHLORIDE 14.6% 100MEQ/40ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS AP 2021-04-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212070-003 SODIUM CHLORIDE 23.4% 400MEQ/100ML (4MEQ/ML) SOLUTION / INTRAVENOUS AP 2022-02-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212070-001 SODIUM CHLORIDE 14.6% 50MEQ/20ML (2.5MEQ/ML) SOLUTION / INTRAVENOUS 2021-04-28 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
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 2.5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807578 Internal RxNorm lookup 1807580 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 63323-090-02 Sodium Chloride 20 mL in 1 VIAL, PLASTIC INJECTION, SOLUTION, CONCENTRATE 20 3 63323-090-04 Sodium Chloride 40 mL in 1 VIAL, PLASTIC INJECTION, SOLUTION, CONCENTRATE 40 3 63323-090-20 Sodium Chloride 25 in 1 TRAY INJECTION, SOLUTION, CONCENTRATE 25 3 63323-090-40 Sodium Chloride 25 in 1 TRAY INJECTION, SOLUTION, CONCENTRATE 25 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-090 SODIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC, 4 package rows 20210501_ed8fd0c1-ac42-4267-877e-ceadf3831c90.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 Marketing end Sample Exclude flag Status 63323-090-02 63323009002 20 mL in 1 VIAL, PLASTIC 20 ml Historical 63323-090-04 63323009004 40 mL in 1 VIAL, PLASTIC 40 ml Historical 63323-090-20 63323009020 25 VIAL, PLASTIC in 1 TRAY (63323-090-20) / 20 mL in 1 VIAL, PLASTIC (63323-090-02) 2021-04-28 0000-00-00 No No Current 63323-090-40 63323009040 25 VIAL, PLASTIC in 1 TRAY (63323-090-40) / 40 mL in 1 VIAL, PLASTIC (63323-090-04) 2021-04-28 0000-00-00 No No Current