Clindamycin in 5 percent Dextrose

Basic Information

Product Name

FDA Product Code

0143-9267

Regulatory Information

NDC Product Code

0143-9267

Application Number

ANDA214401

Marketing Category

C73584

Effective Date

March 8, 2024

Territorial Authority

USA

FDA Title

Clindamycin in 5% Dextrose Injection

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

EDETATE DISODIUM

Quantity: 0.4 mg in 1 mL

Code: 7FLD91C86K

Class Code: IACT

CLINDAMYCIN

Quantity: 6 mg in 1 mL

Code: 3U02EL437C

Class Code: ACTIB

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

DEXTROSE MONOHYDRATE

Quantity: 50 mg in 1 mL

Code: LX22YL083G

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

CLINDAMYCIN

Code: 3U02EL437C

Basic Information

Regulatory Information

Company Information

Active Ingredients

EDETATE DISODIUM

HYDROCHLORIC ACID

DEXTROSE MONOHYDRATE

SODIUM HYDROXIDE

Active Moieties

CLINDAMYCIN