Home NDC 65219-232 Sodium chloride
Product NDC 65219-232
11-digit product format 652190232
Labeler code 65219
Product ID 65219-232_02cd6592-b609-44d9-9fb3-3fb077e9a4fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM CHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA208122
Marketing category ANDA
Marketing start 2018-07-23
Substance SODIUM CHLORIDE
Active strength 2250 mg/500mL
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 42 .
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 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER SODIUM CHLORIDE 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208122-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208122-001 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER 450MG/100ML INJECTABLE / INJECTION AP 2018-07-23 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 2250 mg/500mL
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807548 Internal RxNorm lookup 1807549 Internal RxNorm lookup 1807550 Internal RxNorm lookup 1807551 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 65219-232-01 Sodium chloride 500 mL in 1 BAG INJECTION, SOLUTION 500 4 65219-232-50 Sodium chloride 20 in 1 CASE INJECTION, SOLUTION 20 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-232 SODIUM CHLORIDE (SODIUM CHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 4 Current NDC, Legacy NDC, 2 package rows 20240524_239a5af1-7498-480f-862c-ab7c3d89d183.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 · 3 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 65219-232-01 65219023201 500 mL in 1 BAG 500 ml Historical 65219-232-50 65219023250 20 BAG in 1 CASE (65219-232-50) / 500 mL in 1 BAG (65219-232-01) 20 bag 2021-11-30 0000-00-00 No No Current