Home NDC 0641-1512 Sodium Chloride
Product NDC 0641-1512
11-digit product format 006411512
Labeler code 0641
Product ID 0641-1512_90d2e8c2-7688-4a7d-9a1c-009f4a7e159c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Chloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA201850
Marketing category ANDA
Marketing start 2012-01-20
Marketing end 0000-00-00
Substance SODIUM CHLORIDE
Active strength 9 mg/mL
Pharmacologic classes Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 A201850-001 SODIUM CHLORIDE 0.9% SODIUM CHLORIDE 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20
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 A201850-001 SODIUM CHLORIDE 0.9% 90MG/10ML (9MG/ML) SOLUTION / INJECTION 2012-01-20 a50c72e98297…
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 0641-1512-10 Sodium Chloride 10 mL in 1 AMPULE INJECTION 10 4 0641-1512-36 Sodium Chloride 100 in 1 CARTON INJECTION 100 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-1512 SODIUM CHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 4 Legacy NDC, 2 package rows 20191231_fefc9ea8-a2de-49ab-8d79-d8337248ff0e.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 0641-1512-10 00641151210 10 mL in 1 AMPULE 10 ml Historical 0641-1512-36 00641151236 100 AMPULE in 1 CARTON (0641-1512-36) > 10 mL in 1 AMPULE (0641-1512-10) 100 ampule 2012-01-20 0000-00-00 No No Current