Clindamycin phosphate

Product NDC
0338-3410
11-digit product format
003383410
Labeler code
0338
Product ID
0338-3410_c8906ab2-37d2-4fde-9784-0442bf7b9565
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
ANDA208084
Marketing category
ANDA
Marketing start
2017-06-28
Substance
CLINDAMYCIN PHOSPHATE
Active strength
300 mg/50mL
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 phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE300 mg/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH6D7113I8
Rxcui309335, 309336, 309339

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
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
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
0338-3410-24Clindamycin phosphate24 in 1 CARTONINJECTION, SOLUTION2415
0338-3410-50Clindamycin phosphate50 mL in 1 BAGINJECTION, SOLUTION5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-3410-24ML - Milliliter0338-34106452a888-9eb3-4e87-93c9-27df6d5fd5c712017-08-11
0338-3410-50ML - Milliliter0338-34107713fbc8-a26d-4172-a037-84617ace0aa212017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-3410CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]13Current NDC, Legacy NDC, 2 package rows20250323_78832ac6-04c5-45e0-ae4d-f56d7920dda9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309339clindamycin 300 MG in 50 ML InjectionPSN78832ac6-04c5-45e0-ae4d-f56d7920dda915
309335clindamycin 600 MG in 50 ML InjectionPSN78832ac6-04c5-45e0-ae4d-f56d7920dda915
309336clindamycin 900 MG in 50 ML InjectionPSN78832ac6-04c5-45e0-ae4d-f56d7920dda915
30933550 ML clindamycin 12 MG/ML InjectionSCD78832ac6-04c5-45e0-ae4d-f56d7920dda915
30933650 ML clindamycin 18 MG/ML InjectionSCD78832ac6-04c5-45e0-ae4d-f56d7920dda915
30933950 ML clindamycin 6 MG/ML InjectionSCD78832ac6-04c5-45e0-ae4d-f56d7920dda915
309339clindamycin (as clindamycin phosphate) 300 MG per 50 ML InjectionSY78832ac6-04c5-45e0-ae4d-f56d7920dda915
309335clindamycin (as clindamycin phosphate) 600 MG per 50 ML InjectionSY78832ac6-04c5-45e0-ae4d-f56d7920dda915
309336clindamycin (as clindamycin phosphate) 900 MG per 50 ML InjectionSY78832ac6-04c5-45e0-ae4d-f56d7920dda915
309335clindamycin 600 MG per 50 ML InjectionSY78832ac6-04c5-45e0-ae4d-f56d7920dda915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-3410-240033834102424 BAG in 1 CARTON (0338-3410-24) / 50 mL in 1 BAG (0338-3410-50) 24 bag2017-06-280000-00-00NoNoCurrent
0338-3410-500033834105050 mL in 1 BAG50 mlHistorical