FDA.reportPublic FDA data

Cleocin Phosphate

Product NDC
0009-3051
11-digit product format
000093051
Labeler code
0009
Product ID
0009-3051_8d0dac99-6ec9-4648-8ae1-0cc2894d56cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA050441
Marketing category
NDA
Marketing start
2019-11-18
Marketing end
2026-10-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cleocin Phosphate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE150 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH6D7113I8
Rxcui1737244, 1737245, 1737578, 1737579, 1737581, 1737582

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0009-3051-022024-01-30C16284748780-11030e365-1cf1-111a-e063-dadaa90a10e2CLEOCIN PHOSPHATE ® (clindamycin injection, USP)
0009-3051-022024-01-30C16284748780-11030e365-1cf1-111a-e063-dadaa90a10e2CLEOCIN PHOSPHATE ® (clindamycin injection, USP)
0009-3051-022024-01-30C16284748780-11030e365-1cf1-111a-e063-dadaa90a10e2CLEOCIN PHOSPHATE ® (clindamycin injection, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-3051-01Cleocin Phosphate2 mL in 1 VIALINJECTION, SOLUTION215
0009-3051-02Cleocin Phosphate25 in 1 CARTONINJECTION, SOLUTION2515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-3051-01ML - Milliliter0009-3051fdcbef14-de84-4861-a1b2-56a636d518ff12019-12-10
0009-3051-02ML - Milliliter0009-305100311586-29a4-43c2-a820-dd94e502836812019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-3051CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]11Current NDC, Legacy NDC, 2 package rows20250406_a0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737245Cleocin Phosphate 300 MG in 2 ML InjectionPSNa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737579Cleocin Phosphate 600 MG in 4 ML InjectionPSNa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737582Cleocin Phosphate 900 MG in 6 ML InjectionPSNa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737244clindamycin 300 MG in 2 ML InjectionPSNa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737578clindamycin 600 MG in 4 ML InjectionPSNa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737581clindamycin 900 MG in 6 ML InjectionPSNa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
17372452 ML clindamycin 150 MG/ML Injection [Cleocin]SBDa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
17375794 ML clindamycin 150 MG/ML Injection [Cleocin]SBDa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
17375826 ML clindamycin 150 MG/ML Injection [Cleocin]SBDa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
17372442 ML clindamycin 150 MG/ML InjectionSCDa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
17375784 ML clindamycin 150 MG/ML InjectionSCDa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
17375816 ML clindamycin 150 MG/ML InjectionSCDa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737245Cleocin (as clindamycin phosphate) 300 MG per 2 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737579Cleocin (as clindamycin phosphate) 600 MG per 4 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737582Cleocin (as clindamycin phosphate) 900 MG per 6 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737582Cleocin 900 MG per 6 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737245Cleocin Phosphate 300 MG per 2 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737579Cleocin Phosphate 600 MG per 4 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737244clindamycin (as clindamycin phosphate) 300 MG per 2 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737578clindamycin (as clindamycin phosphate) 600 MG per 4 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737581clindamycin (as clindamycin phosphate) 900 MG per 6 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737244clindamycin 300 MG per 2 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737578clindamycin 600 MG per 4 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15
1737581clindamycin 900 MG per 6 ML InjectionSYa0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-3051-01000093051012 mL in 1 VIAL2 mlHistorical
0009-3051-020000930510225 VIAL in 1 CARTON (0009-3051-02) / 2 mL in 1 VIAL (0009-3051-01) 25 vial2019-11-182026-10-31NoNoCurrent