FDA.reportPublic FDA data

Clindamycin

Product NDC
25021-115
11-digit product format
250210115
Labeler code
25021
Product ID
25021-115_4662502b-ce7c-4278-854d-cf8632ac9b83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA090108
Marketing category
ANDA
Marketing start
2012-05-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25021-115-022024-01-30C16284748780-11030e365-4052-111a-e063-dadaa90a10e2Clindamycin Injection, USP
25021-115-042024-01-30C16284748780-11030e365-4052-111a-e063-dadaa90a10e2Clindamycin Injection, USP
25021-115-062024-01-30C16284748780-11030e365-4052-111a-e063-dadaa90a10e2Clindamycin Injection, USP
25021-115-512024-01-30C16284748780-11030e364-fe4a-111a-e063-dadaa90a10e2458e043d-6584-4503-b398-2032d3cce2f1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-115-02Clindamycin2 mL in 1 VIALINJECTION, SOLUTION221
25021-115-02Clindamycin25 in 1 CARTONINJECTION, SOLUTION2521
25021-115-04Clindamycin4 mL in 1 VIALINJECTION, SOLUTION421
25021-115-04Clindamycin25 in 1 CARTONINJECTION, SOLUTION2521
25021-115-06Clindamycin25 in 1 CARTONINJECTION, SOLUTION2521
25021-115-06Clindamycin6 mL in 1 VIALINJECTION, SOLUTION621

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-115-02ML - Milliliter25021-1152771c521-03c6-4aa5-bb02-ed15bfc09cb512012-07-24
25021-115-04ML - Milliliter25021-115bc8054e2-487c-4de0-bc0b-6a9f3513a26412012-07-24
25021-115-06ML - Milliliter25021-1156215a90d-28f5-4bc4-97bd-545c8623cff712012-07-24
25021-115-51ML - Milliliter25021-1154c6aba6d-cd07-43f9-bb56-a663a58363fb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clindamycin phosphateACTIVE INGREDIENTEH6D7113I8CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]11
clindamycinACTIVE MOIETY3U02EL437CCLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]11
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]11
edetate disodiumINACTIVE INGREDIENT7FLD91C86KCLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]11
hydrochloric acidINACTIVE INGREDIENTQTT17582CBCLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]11
sodium hydroxideINACTIVE INGREDIENT55X04QC32ICLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-115CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]21Current NDC, Legacy NDC, 6 package rows20241025_7a6967b3-5563-4bed-9eee-d400f800e799.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737244clindamycin 300 MG in 2 ML InjectionPSN7a6967b3-5563-4bed-9eee-d400f800e79921
1737578clindamycin 600 MG in 4 ML InjectionPSN7a6967b3-5563-4bed-9eee-d400f800e79921
1737581clindamycin 900 MG in 6 ML InjectionPSN7a6967b3-5563-4bed-9eee-d400f800e79921
17372442 ML clindamycin 150 MG/ML InjectionSCD7a6967b3-5563-4bed-9eee-d400f800e79921
17375784 ML clindamycin 150 MG/ML InjectionSCD7a6967b3-5563-4bed-9eee-d400f800e79921
17375816 ML clindamycin 150 MG/ML InjectionSCD7a6967b3-5563-4bed-9eee-d400f800e79921
1737244clindamycin (as clindamycin phosphate) 300 MG per 2 ML InjectionSY7a6967b3-5563-4bed-9eee-d400f800e79921
1737578clindamycin (as clindamycin phosphate) 600 MG per 4 ML InjectionSY7a6967b3-5563-4bed-9eee-d400f800e79921
1737581clindamycin (as clindamycin phosphate) 900 MG per 6 ML InjectionSY7a6967b3-5563-4bed-9eee-d400f800e79921
1737244clindamycin 300 MG per 2 ML InjectionSY7a6967b3-5563-4bed-9eee-d400f800e79921
1737578clindamycin 600 MG per 4 ML InjectionSY7a6967b3-5563-4bed-9eee-d400f800e79921
1737581clindamycin 900 MG per 6 ML InjectionSY7a6967b3-5563-4bed-9eee-d400f800e79921
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
1737244clindamycin 300 MG in 2 ML InjectionPSN9e4fc2d5-985a-3734-e053-2995a90aef5b3
1737581clindamycin 900 MG in 6 ML InjectionPSNdc8b8a09-3eed-1998-e053-2995a90a2f603
17372442 ML clindamycin 150 MG/ML InjectionSCD9e4fc2d5-985a-3734-e053-2995a90aef5b3
17375816 ML clindamycin 150 MG/ML InjectionSCDdc8b8a09-3eed-1998-e053-2995a90a2f603
1737244clindamycin (as clindamycin phosphate) 300 MG per 2 ML InjectionSY9e4fc2d5-985a-3734-e053-2995a90aef5b3
1737581clindamycin (as clindamycin phosphate) 900 MG per 6 ML InjectionSYdc8b8a09-3eed-1998-e053-2995a90a2f603
1737244clindamycin 300 MG per 2 ML InjectionSY9e4fc2d5-985a-3734-e053-2995a90aef5b3
1737581clindamycin 900 MG per 6 ML InjectionSYdc8b8a09-3eed-1998-e053-2995a90a2f603
205964clindamycin 150 MG/ML Injectable SolutionPSN9e545c9d-dc39-584c-e053-2995a90afda42
1737578clindamycin 600 MG in 4 ML InjectionPSN9e500a08-0339-eb6b-e053-2a95a90a130c2
17375784 ML clindamycin 150 MG/ML InjectionSCD9e500a08-0339-eb6b-e053-2a95a90a130c2
205964clindamycin 150 MG/ML Injectable SolutionSCD9e545c9d-dc39-584c-e053-2995a90afda42
205964clindamycin (as clindamycin phosphate) 150 MG/ML Injectable SolutionSY9e545c9d-dc39-584c-e053-2995a90afda42
1737578clindamycin (as clindamycin phosphate) 600 MG per 4 ML InjectionSY9e500a08-0339-eb6b-e053-2a95a90a130c2
1737578clindamycin 600 MG per 4 ML InjectionSY9e500a08-0339-eb6b-e053-2a95a90a130c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-115-022502101150225 VIAL in 1 CARTON (25021-115-02) / 2 mL in 1 VIAL25 vial2012-05-150000-00-00NoNoCurrent
25021-115-042502101150425 VIAL in 1 CARTON (25021-115-04) / 4 mL in 1 VIAL25 vial2012-05-150000-00-00NoNoCurrent
25021-115-062502101150625 VIAL in 1 CARTON (25021-115-06) / 6 mL in 1 VIAL25 vial2012-05-150000-00-00NoNoCurrent
25021-115-51250210115511 BOTTLE in 1 CARTON (25021-115-51) > 60 mL in 1 BOTTLE1 bottle2012-05-150000-00-00NoNoCurrent