Clindamycin hydrochloride

Product NDC
33261-159
11-digit product format
332610159
Labeler code
33261
Product ID
33261-159_8eb8b8e7-e935-4074-8a7a-d1e9116fd6f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065061
Marketing category
ANDA
Marketing start
2001-03-23
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
No
Listing certified through
2019-12-31
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
33261-159-30Clindamycin hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301
33261-159-40Clindamycin hydrochloride40 in 1 BOTTLE, PLASTICCAPSULE401
33261-159-42Clindamycin hydrochloride42 in 1 BOTTLE, PLASTICCAPSULE421
33261-159-60Clindamycin hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-159-30EA - Each33261-159589f29e3-6af6-4db9-b2dc-eaacb3c864b812015-10-02
33261-159-40EA - Each33261-1599fd3cf00-66e0-4b3c-ae2f-5c10ade2eb8e12015-10-02
33261-159-42EA - Each33261-159e99c24dd-89be-412e-9b1a-d9afc4533b6612015-10-02
33261-159-60EA - Each33261-159f194d9a9-edae-4561-b1f2-4d6210d2467612015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-159CLINDAMYCIN HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140102_c738fa18-685d-4a63-955d-8e8421ef4eb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSNc738fa18-685d-4a63-955d-8e8421ef4eb01
284215clindamycin HCl 300 MG Oral CapsulePSNc738fa18-685d-4a63-955d-8e8421ef4eb01
197518clindamycin 150 MG Oral CapsuleSCDc738fa18-685d-4a63-955d-8e8421ef4eb01
284215clindamycin 300 MG Oral CapsuleSCDc738fa18-685d-4a63-955d-8e8421ef4eb01
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSYc738fa18-685d-4a63-955d-8e8421ef4eb01
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYc738fa18-685d-4a63-955d-8e8421ef4eb01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-159-303326101593030 in 1 BOTTLE, PLASTICHistorical
33261-159-403326101594040 in 1 BOTTLE, PLASTICHistorical
33261-159-423326101594242 in 1 BOTTLE, PLASTICHistorical
33261-159-603326101596060 in 1 BOTTLE, PLASTICHistorical