Home NDC 63323-626 Sodium chloride
Product NDC 63323-626
11-digit product format 633230626
Labeler code 63323
Product ID 63323-626_713303dd-2658-4037-8583-a12a38eb367b
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 450 mg/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 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 450 mg/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 · 5 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 1807552 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 63323-626-00 Sodium chloride 50 in 1 CASE INJECTION, SOLUTION 50 7 63323-626-01 Sodium chloride 50 mL in 1 BAG INJECTION, SOLUTION 50 7 63323-626-02 Sodium chloride 100 mL in 1 BAG INJECTION, SOLUTION 100 7 63323-626-03 Sodium chloride 250 mL in 1 BAG INJECTION, SOLUTION 250 7 63323-626-04 Sodium chloride 500 mL in 1 BAG INJECTION, SOLUTION 500 7 63323-626-05 Sodium chloride 1000 mL in 1 BAG INJECTION, SOLUTION 1000 7 63323-626-10 Sodium chloride 10 in 1 CASE INJECTION, SOLUTION 10 7 63323-626-25 Sodium chloride 30 in 1 CASE INJECTION, SOLUTION 30 7 63323-626-50 Sodium chloride 60 in 1 CASE INJECTION, SOLUTION 60 7 63323-626-55 Sodium chloride 20 in 1 CASE INJECTION, SOLUTION 20 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-626 SODIUM CHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 7 Current NDC, Legacy NDC, 10 package rows 20240806_83994d0c-8484-4505-abb5-8a384ed12288.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 63323-626-00 63323062600 50 BAG in 1 CASE (63323-626-00) / 100 mL in 1 BAG (63323-626-02) 50 bag 2018-07-23 0000-00-00 No No Current 63323-626-01 63323062601 50 mL in 1 BAG 50 ml Historical 63323-626-02 63323062602 100 mL in 1 BAG 100 ml Historical 63323-626-03 63323062603 250 mL in 1 BAG 250 ml Historical 63323-626-04 63323062604 500 mL in 1 BAG 500 ml Historical 63323-626-05 63323062605 1000 mL in 1 BAG 1000 ml Historical 63323-626-10 63323062610 10 BAG in 1 CASE (63323-626-10) / 1000 mL in 1 BAG (63323-626-05) 10 bag 2018-07-23 0000-00-00 No No Current 63323-626-25 63323062625 30 BAG in 1 CASE (63323-626-25) / 250 mL in 1 BAG (63323-626-03) 30 bag 2018-07-23 0000-00-00 No No Current 63323-626-50 63323062650 60 BAG in 1 CASE (63323-626-50) / 50 mL in 1 BAG (63323-626-01) 60 bag 2018-07-23 0000-00-00 No No Current 63323-626-55 63323062655 20 BAG in 1 CASE (63323-626-55) / 500 mL in 1 BAG (63323-626-04) 20 bag 2018-07-23 0000-00-00 No No Current