Chloramphenicol Sodium Succinate

Product NDC
63323-011
11-digit product format
633230011
Labeler code
63323
Product ID
63323-011_f0af962d-5024-47cf-b7a0-da9b5ff3c994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORAMPHENICOL SODIUM SUCCINATE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA062365
Marketing category
ANDA
Marketing start
2001-01-12
Substance
CHLORAMPHENICOL SODIUM SUCCINATE
Active strength
1 g/10mL
Pharmacologic classes
Amphenicol-class Antibacterial [EPC], Amphenicols [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chloramphenicol Sodium Succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORAMPHENICOL SODIUM SUCCINATE1 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii872109HX6B
Rxcui239200

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-011-15Chloramphenicol Sodium Succinate10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,106
63323-011-15Chloramphenicol Sodium Succinate10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-011-15EA - Each63323-011199822e4-6cb3-4f2b-8bdd-e96fb0fe16c512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORAMPHENICOL SODIUM SUCCINATEACTIVE INGREDIENT872109HX6BCHLORAMPHENICOL SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2
CHLORAMPHENICOLACTIVE MOIETY66974FR9Q1CHLORAMPHENICOL SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-011CHLORAMPHENICOL SODIUM SUCCINATE (CHLORAMPHENICOL SODIUM SUCCINATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20241013_aed29594-211d-49ef-813f-131975a8d0e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239200chloramphenicol 100 MG/ML Injectable SolutionPSNaed29594-211d-49ef-813f-131975a8d0e36
239200chloramphenicol 100 MG/ML Injectable SolutionSCDaed29594-211d-49ef-813f-131975a8d0e36
239200chloramphenicol (as chloramphenicol sodium succinate) 1 GM per 10 ML Powder for Injectable SolutionSYaed29594-211d-49ef-813f-131975a8d0e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-011-156332300111510 VIAL in 1 TRAY (63323-011-15) / 10 mL in 1 VIAL10 vial2001-01-120000-00-00NoNoCurrent