Home NDC 46163-300 Sodium Chloride
Product NDC 46163-300
11-digit product format 461630300
Labeler code 46163
Product ID 46163-300_4e7bc97a-4d31-b66d-e063-6294a90a294c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Chloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Fresenius Medical Care de Mexico, S.A. de C.V.
Application ANDA078177
Marketing category ANDA
Marketing start 2007-04-12
Substance SODIUM CHLORIDE
Active strength 900 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 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 46163-300 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 46163-300 46163-300-10 I Inactivated by FDA excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER SODIUM CHLORIDE 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078177-001 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 · 41 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 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078177-001 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER 900MG/100ML INJECTABLE / INJECTION AP 2007-04-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sodium Chloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CHLORIDE 900 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807639 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46163-300-10 Sodium Chloride 12 in 1 CARTON INJECTION 12 14 46163-300-10 Sodium Chloride 1000 mL in 1 BAG INJECTION 1000 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46163-300 SODIUM CHLORIDE (SODIUM CHLORIDE) INJECTION [FRESENIUS MEDICAL CARE DE MEXICO, S.A. DE C.V.] 11 Current NDC, Legacy NDC, 2 package rows 20241109_9a1220fb-6853-45ae-838c-10d8596e1af7.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 46163-300-10 46163030010 12 BAG in 1 CARTON (46163-300-10) / 1000 mL in 1 BAG 12 bag 2007-04-12 0000-00-00 No No Current