Home NDC 0641-0497 Sodium Chloride
Product NDC 0641-0497
11-digit product format 006410497
Labeler code 0641
Product ID 0641-0497_0950e98d-bfec-40e8-9f56-ba90e0d6e8c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Chloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA201833
Marketing category ANDA
Marketing start 2013-09-24
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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201833-001 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 A201833-002 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201833-002 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.
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 2026-08-01 22:54:32 2026-06 A201833-001 SODIUM CHLORIDE 0.9% 18MG/2ML (9MG/ML) SOLUTION / INJECTION 2013-09-24 a50c72e98297…2026-08-01 22:54:32 2026-06 A201833-002 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION AP 2015-01-07 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A201833-002 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1807636 Internal RxNorm lookup 1807637 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 0641-0497-17 Sodium Chloride 2 mL in 1 VIAL INJECTION 2 12 0641-0497-25 Sodium Chloride 25 in 1 CARTON INJECTION 25 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-0497 SODIUM CHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 12 Current NDC, Legacy NDC, 2 package rows 20240412_e5ee8caa-b6ca-45ba-98fb-8305e6282141.zip
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 0641-0497-17 00641049717 2 mL in 1 VIAL 2 ml Historical 0641-0497-25 00641049725 25 VIAL in 1 CARTON (0641-0497-25) / 2 mL in 1 VIAL (0641-0497-17) 25 vial 2013-09-24 0000-00-00 No No Current