Home NDC 0093-3560 PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
Product NDC 0093-3560
11-digit product format 000933560
Labeler code 0093
Product ID 0093-3560_46e37694-3149-46b3-a949-fad3ccbb8052
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
Dosage form KIT
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA090145
Marketing category ANDA
Marketing start 2020-08-31
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
Listing expiration 2026-12-31 Harmonized Identifiers# Field, Values table Field Values Rxcui 800915
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-3560-19 PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID 1 in 1 CARTON KIT 1 3 0093-3560-26 PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID 2 in 1 CARTON KIT 2 3 0093-9043-19 PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID 1 L in 1 POUCH POWDER, FOR SOLUTION 1 L 4.7 g in 1L 3 0093-9044-19 PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID 1 L in 1 POUCH POWDER, FOR SOLUTION 1 L 7.5 g in 1L 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-3560 PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID (PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID) KIT [TEVA PHARMACEUTICALS USA, INC.] 3 Current NDC, Legacy NDC, 4 package rows 20230223_475a06c6-f295-406c-a110-f1497cf51566.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 800915 ascorbic acid 4.7 GM / polyethylene glycol 3350 100 GM / potassium chloride 1.015 GM / sodium ascorbate 5.9 GM / sodium chloride 2.69 GM / sodium sulfate 7.5 GM Powder for Oral Solution PSN 475a06c6-f295-406c-a110-f1497cf51566 3 800915 ascorbic acid 4700 MG / polyethylene glycol 3350 100000 MG / potassium chloride 1015 MG / sodium ascorbate 5900 MG / sodium chloride 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution SCD 475a06c6-f295-406c-a110-f1497cf51566 3 800915 ascorbic acid 4.7 GM / polyethylene glycol 3350 100 GM / potassium chloride 1.015 GM / sodium ascorbate 5.9 GM / sodium chloride 2.69 GM / sodium sulfate 7.5 GM Powder for Oral Solution SY 475a06c6-f295-406c-a110-f1497cf51566 3 800915 vit-C 4700 MG / POLYETHYLENE GLYCOL 3350 100000 MG / K+ Chloride 1015 MG / Sodium Ascorbate 5900 MG / NaCl 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution SY 475a06c6-f295-406c-a110-f1497cf51566 3 800915 vit-C 4700 MG / POLYETHYLENE GLYCOL 3350 100000 MG / Pot Chloride 1015 MG / Sodium Ascorbate 5900 MG / NaCl 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution SY 475a06c6-f295-406c-a110-f1497cf51566 3 800915 vitamin C 4700 MG / POLYETHYLENE GLYCOL 3350 100000 MG / K+ Chloride 1015 MG / Sodium Ascorbate 5900 MG / NaCl 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution SY 475a06c6-f295-406c-a110-f1497cf51566 3 800915 vitamin C 4700 MG / POLYETHYLENE GLYCOL 3350 100000 MG / Pot Chloride 1015 MG / Sodium Ascorbate 5900 MG / NaCl 2690 MG / sodium sulfate 7500 MG Powder for Oral Solution SY 475a06c6-f295-406c-a110-f1497cf51566 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0093-3560-19 00093356019 1 in 1 CARTON Historical 0093-3560-26 00093356026 2 CARTON in 1 CARTON (0093-3560-26) / 1 KIT in 1 CARTON (0093-3560-19) * 1 L in 1 POUCH (0093-9043-19) * 1 L in 1 POUCH * 1 L in 1 POUCH (0093-9044-19) 2 carton 2020-08-31 0000-00-00 No No Current 0093-9043-19 00093904319 1 L in 1 POUCH 1 l Historical 0093-9044-19 00093904419 1 L in 1 POUCH 1 l Historical