Clindamycin

Product NDC
0404-9838
11-digit product format
004049838
Labeler code
0404
Product ID
0404-9838_818d5172-0214-4204-b2e6-6266ce15e8e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA090108
Marketing category
ANDA
Marketing start
2022-01-09
Substance
CLINDAMYCIN PHOSPHATE
Active strength
150 mg/mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE150 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH6D7113I8
Rxcui1737244, 1737578, 1737581

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d8f81258-db12-0761-46cc-8ff6e62e9302Product name420240422
b7b2fa42-1c77-d724-81f0-87da60a77e79Product name320240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9838-02Clindamycin2 mL in 1 VIALINJECTION, SOLUTION26
0404-9838-02Clindamycin1 in 1 BAGINJECTION, SOLUTION16
0404-9838-04Clindamycin4 mL in 1 VIALINJECTION, SOLUTION46
0404-9838-04Clindamycin1 in 1 BAGINJECTION, SOLUTION16
0404-9838-06Clindamycin1 in 1 BAGINJECTION, SOLUTION16
0404-9838-06Clindamycin6 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9838CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 6 package rows20250410_8a4e2ba4-90e6-48e8-a943-0c5d3f169780.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737244clindamycin 300 MG in 2 ML InjectionPSN8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737578clindamycin 600 MG in 4 ML InjectionPSN8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737581clindamycin 900 MG in 6 ML InjectionPSN8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
17372442 ML clindamycin 150 MG/ML InjectionSCD8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
17375784 ML clindamycin 150 MG/ML InjectionSCD8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
17375816 ML clindamycin 150 MG/ML InjectionSCD8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737244clindamycin (as clindamycin phosphate) 300 MG per 2 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737578clindamycin (as clindamycin phosphate) 600 MG per 4 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737581clindamycin (as clindamycin phosphate) 900 MG per 6 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737244clindamycin 300 MG per 2 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737578clindamycin 600 MG per 4 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806
1737581clindamycin 900 MG per 6 ML InjectionSY8a4e2ba4-90e6-48e8-a943-0c5d3f1697806

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9838-02004049838021 VIAL in 1 BAG (0404-9838-02) > 2 mL in 1 VIAL1 vial2022-01-090000-00-00NoNoCurrent
0404-9838-04004049838041 VIAL in 1 BAG (0404-9838-04) / 4 mL in 1 VIAL1 vial2022-01-092026-12-31NoNoCurrent
0404-9838-06004049838061 VIAL, SINGLE-DOSE in 1 BAG (0404-9838-06) > 6 mL in 1 VIAL, SINGLE-DOSE2022-01-090000-00-00NoNoCurrent