Cleocin

Product NDC
0009-7667
11-digit product format
000097667
Labeler code
0009
Product ID
0009-7667_187697a2-a941-4fe8-9be2-c442d0fd5e07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA050767
Marketing category
NDA
Marketing start
2024-02-03
Substance
CLINDAMYCIN PHOSPHATE
Active strength
100 mg/1
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
Cleocin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH6D7113I8
Rxcui259233, 882533

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
0009-7667-05Cleocin3 in 1 BLISTER PACKSUPPOSITORY332
0009-7667-05Cleocin1 in 1 CARTONSUPPOSITORY132

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-7667-01EA - Each0009-7667906628ee-4412-4da9-8d7e-383c942d809d12012-07-24
0009-7667-05EA - Each0009-76674ca43042-bad8-4dbf-b0cc-016f059711c512024-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN PHOSPHATEACTIVE INGREDIENTEH6D7113I8CLEOCIN (CLINDAMYCIN PHOSPHATE) SUPPOSITORY [PHARMACIA AND UPJOHN COMPANY]10
CLINDAMYCINACTIVE MOIETY3U02EL437CCLEOCIN (CLINDAMYCIN PHOSPHATE) SUPPOSITORY [PHARMACIA AND UPJOHN COMPANY]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-7667CLEOCIN (CLINDAMYCIN PHOSPHATE) SUPPOSITORY [PHARMACIA & UPJOHN COMPANY LLC]30Current NDC, Legacy NDC, 2 package rows20250410_3db26227-208d-4fdd-8426-1d9be5cda9b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
882533Cleocin 100 MG Vaginal InsertPSN3db26227-208d-4fdd-8426-1d9be5cda9b432
259233clindamycin phosphate 100 MG Vaginal InsertPSN3db26227-208d-4fdd-8426-1d9be5cda9b432
882533clindamycin 100 MG Vaginal Insert [Cleocin]SBD3db26227-208d-4fdd-8426-1d9be5cda9b432
259233clindamycin 100 MG Vaginal InsertSCD3db26227-208d-4fdd-8426-1d9be5cda9b432
882533Cleocin (as clindamycin phosphate) 100 MG Vaginal InsertSY3db26227-208d-4fdd-8426-1d9be5cda9b432
882533Cleocin 100 MG Vaginal InsertSY3db26227-208d-4fdd-8426-1d9be5cda9b432
259233clindamycin (as clindamycin phosphate) 100 MG Vaginal InsertSY3db26227-208d-4fdd-8426-1d9be5cda9b432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-7667-01000097667011 BLISTER PACK in 1 CARTON (0009-7667-01) > 3 SUPPOSITORY in 1 BLISTER PACK1 blister pack1999-08-130000-00-00NoNoCurrent
0009-7667-05000097667051 BLISTER PACK in 1 CARTON (0009-7667-05) / 3 SUPPOSITORY in 1 BLISTER PACK1 blister pack2024-02-030000-00-00NoNoCurrent