Home NDC 64253-202 sodium chloride
Product NDC 64253-202
11-digit product format 642530202
Labeler code 64253
Product ID 64253-202_4bbe9ad8-075c-216b-e063-6294a90a1024
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM CHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Medefil, Inc.
Application NDA202832
Marketing category NDA
Marketing start 2012-01-13
Substance SODIUM CHLORIDE
Active strength 9 mg/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 2027-12-31
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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202832-001 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 9MG/ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 N202832-002 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 18MG/2ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 N202832-003 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 22.5MG/2.5ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 N202832-004 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 27MG/3ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 N202832-005 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 45MG/5ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 N202832-006 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 90MG/10ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06
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 7 · 252 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 N202832-001 SODIUM CHLORIDE 0.9% 9MG/ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202832-002 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202832-003 SODIUM CHLORIDE 0.9% 22.5MG/2.5ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202832-004 SODIUM CHLORIDE 0.9% 27MG/3ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202832-005 SODIUM CHLORIDE 0.9% 45MG/5ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202832-006 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202832-001 SODIUM CHLORIDE 0.9% 9MG/ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202832-002 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202832-003 SODIUM CHLORIDE 0.9% 22.5MG/2.5ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202832-004 SODIUM CHLORIDE 0.9% 27MG/3ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202832-005 SODIUM CHLORIDE 0.9% 45MG/5ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202832-006 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202832-001 SODIUM CHLORIDE 0.9% 9MG/ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202832-002 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202832-003 SODIUM CHLORIDE 0.9% 22.5MG/2.5ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202832-004 SODIUM CHLORIDE 0.9% 27MG/3ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202832-005 SODIUM CHLORIDE 0.9% 45MG/5ML (9MG/ML) INJECTABLE / INJECTION RLD 2012-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202832-006 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202832-001 SODIUM CHLORIDE 0.9% 9MG/ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202832-002 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202832-003 SODIUM CHLORIDE 0.9% 22.5MG/2.5ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202832-004 SODIUM CHLORIDE 0.9% 27MG/3ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202832-005 SODIUM CHLORIDE 0.9% 45MG/5ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202832-006 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202832-001 SODIUM CHLORIDE 0.9% 9MG/ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202832-002 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202832-003 SODIUM CHLORIDE 0.9% 22.5MG/2.5ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202832-004 SODIUM CHLORIDE 0.9% 27MG/3ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202832-005 SODIUM CHLORIDE 0.9% 45MG/5ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202832-006 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202832-001 SODIUM CHLORIDE 0.9% 9MG/ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202832-002 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202832-003 SODIUM CHLORIDE 0.9% 22.5MG/2.5ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202832-004 SODIUM CHLORIDE 0.9% 27MG/3ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202832-005 SODIUM CHLORIDE 0.9% 45MG/5ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202832-006 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202832-001 SODIUM CHLORIDE 0.9% 9MG/ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202832-002 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202832-003 SODIUM CHLORIDE 0.9% 22.5MG/2.5ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202832-004 SODIUM CHLORIDE 0.9% 27MG/3ML (9MG/ML) INJECTABLE / INJECTION RLD, RS 2012-01-06 03ed91905a0d…
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 9 mg/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 727820 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# Effective, Related label table Effective Related label 2024-03-05 These highlights do not include all the information needed to use SODIUM CHLORIDE INJECTION, USP, 0.9% safely and effectively. See full prescribing information for SODIUM CHLORIDE INJECTION, USP, 0.9%. SODIUM CHLORIDE INJECTION, USP, 0.9% Initial U.S. Approval: 2012 2024-01-30 These highlights do not include all the information needed to use SODIUM CHLORIDE INJECTION, USP, 0.9% safely and effectively. See full prescribing information for SODIUM CHLORIDE INJECTION, USP, 0.9%. SODIUM CHLORIDE INJECTION, USP, 0.9% Initial U.S. Approval: 2012 2021-03-03 These highlights do not include all the information needed to use SODIUM CHLORIDE INJECTION, USP, 0.9% safely and effectively. See full prescribing information for SODIUM CHLORIDE INJECTION, USP, 0.9%. SODIUM CHLORIDE INJECTION, USP, 0.9% Initial U.S. Approval: 2012 2021-01-29 These highlights do not include all the information needed to use SODIUM CHLORIDE INJECTION, USP, 0.9% safely and effectively. See full prescribing information for SODIUM CHLORIDE INJECTION, USP, 0.9%. SODIUM CHLORIDE INJECTION, USP, 0.9% Initial U.S. Approval: 2012
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64253-202-30 sodium chloride 10 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 10 21 64253-202-30 sodium chloride 60 in 1 BOX INJECTION, SOLUTION 60 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64253-202 SODIUM CHLORIDE INJECTION, SOLUTION [MEDEFIL, INC.] 20 Current NDC, Legacy NDC, 2 package rows 20240307_d1468c0f-dd4f-4d38-a84c-c1d110303965.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 Marketing start Marketing end Sample Exclude flag Status 64253-202-30 64253020230 60 SYRINGE, PLASTIC in 1 BOX (64253-202-30) / 10 mL in 1 SYRINGE, PLASTIC 2012-01-13 0000-00-00 No No Current