Clindamycin hydrochloride

Product NDC
10544-153
11-digit product format
105440153
Labeler code
10544
Product ID
10544-153_deed27f1-99b9-4393-ae8b-3f1b7b6f31bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA065061
Marketing category
ANDA
Marketing start
2010-11-01
Marketing end
0000-00-00
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-153-30Clindamycin hydrochloride30 in 1 BOTTLECAPSULE301
10544-153-40Clindamycin hydrochloride40 in 1 BOTTLECAPSULE401
10544-153-42Clindamycin hydrochloride42 in 1 CARTONCAPSULE421

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-153-40EA - Each10544-1533f06ea68-6cb7-4631-9aac-06e3a33fd29812015-05-05
10544-153-42EA - Each10544-153fcf3f3ce-1dce-4c62-bcd6-225593e214e212015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-153CLINDAMYCIN HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 3 package rows20150221_deed27f1-99b9-4393-ae8b-3f1b7b6f31bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSNdeed27f1-99b9-4393-ae8b-3f1b7b6f31bf1
197518clindamycin 150 MG Oral CapsuleSCDdeed27f1-99b9-4393-ae8b-3f1b7b6f31bf1
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYdeed27f1-99b9-4393-ae8b-3f1b7b6f31bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-153-301054401533030 in 1 BOTTLEHistorical
10544-153-401054401534040 in 1 BOTTLEHistorical
10544-153-421054401534242 in 1 CARTONHistorical