NDC 70529-136

Amphenol-40

Sodium Chloride

Amphenol-40 is a Intramuscular; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by It3 Medical Llc. The primary component is Sodium Chloride.

Product ID70529-136_05e0b671-1db7-44e6-983c-97ed0c47ed8e
NDC70529-136
Product TypeHuman Prescription Drug
Proprietary NameAmphenol-40
Generic NameSodium Chloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2017-03-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA018803
Labeler NameIT3 Medical LLC
Substance NameSODIUM CHLORIDE
Active Ingredient Strength9 mg/mL
Pharm ClassesOsmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70529-136-02

1 VIAL, SINGLE-DOSE in 1 PACKAGE (70529-136-02) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70529-136-02 [70529013602]

Amphenol-40 INJECTION, SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA018803
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM CHLORIDE9 mg/mL

OpenFDA Data

SPL SET ID:cbcdc635-ab36-46a0-af69-6f6d0c5f6ebb
Manufacturer
UNII

Pharmacological Class

  • Osmotic Laxative [EPC]
  • Increased Large Intestinal Motility [PE]
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
  • Osmotic Activity [MoA]

NDC Crossover Matching brand name "Amphenol-40" or generic name "Sodium Chloride"

NDCBrand NameGeneric Name
70529-136Amphenol-40Amphenol-40
0220-0432Aqua marinaSODIUM CHLORIDE
0220-3582Natrum muriaticumSODIUM CHLORIDE
0220-3583Natrum muriaticumSODIUM CHLORIDE
0220-3586Natrum muriaticumSODIUM CHLORIDE
0220-3587Natrum muriaticumSODIUM CHLORIDE
0220-3590Natrum muriaticumSODIUM CHLORIDE
0220-3593Natrum muriaticumSODIUM CHLORIDE
0220-3595Natrum muriaticumSODIUM CHLORIDE
0220-3596Natrum muriaticumSODIUM CHLORIDE
0220-3597Natrum muriaticumSODIUM CHLORIDE
0220-3598Natrum muriaticumSODIUM CHLORIDE
0220-3599Natrum muriaticumSODIUM CHLORIDE
0220-3600Natrum muriaticumSODIUM CHLORIDE
0220-3601Natrum muriaticumSODIUM CHLORIDE
0019-1188SODIUM CHLORIDEsodium chloride
0264-1800Sodium ChlorideSodium Chloride
0264-2201Sodium ChlorideSodium Chloride
0264-5802Sodium ChlorideSODIUM CHLORIDE
0264-5804Sodium ChlorideSODIUM CHLORIDE
0264-7800Sodium ChlorideSodium Chloride
0264-7802Sodium ChlorideSODIUM CHLORIDE
0264-7805Sodium ChlorideSodium Chloride
0264-7806Sodium ChlorideSodium Chloride
0264-9375Sodium ChlorideSodium Chloride
0264-9999Sodium ChlorideSodium Chloride
0338-0043Sodium ChlorideSodium Chloride
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.