FDA.reportPublic FDA data

Clindamycin hydrochloride

Product NDC
0904-5959
11-digit product format
009045959
Labeler code
0904
Product ID
0904-5959_6bac37f8-6c52-432c-8840-0a8b6ef027e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA065061
Marketing category
ANDA
Marketing start
2009-04-10
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
150 mg/1
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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT20OQ1YN1W
Rxcui197518

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
0904-5959-61Clindamycin hydrochloride100 in 1 CARTONCAPSULE10016
0904-5959-61Clindamycin hydrochloride1 in 1 BLISTER PACKCAPSULE116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5959-61EA - Each0904-5959f5e56858-0033-4617-9017-87e5d4a7c03812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN HYDROCHLORIDEACTIVE INGREDIENTT20OQ1YN1WCLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
GELATININACTIVE INGREDIENT2G86QN327LCLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
SHELLACINACTIVE INGREDIENT46N107B71OCLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
TALCINACTIVE INGREDIENT7SEV7J4R1UCLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5959CLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]15Current NDC, Legacy NDC, 2 package rows20250514_f9e6ed50-ad03-4a9e-8760-8733e04a058c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSNf9e6ed50-ad03-4a9e-8760-8733e04a058c16
197518clindamycin 150 MG Oral CapsuleSCDf9e6ed50-ad03-4a9e-8760-8733e04a058c16
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYf9e6ed50-ad03-4a9e-8760-8733e04a058c16
197518clindamycin HCl 150 MG Oral CapsulePSNb22be885-f441-473e-879a-862588dcf89d9
197518clindamycin 150 MG Oral CapsuleSCDb22be885-f441-473e-879a-862588dcf89d9
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYb22be885-f441-473e-879a-862588dcf89d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5959-6100904595961100 BLISTER PACK in 1 CARTON (0904-5959-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2009-04-100000-00-00NoNoCurrent