Clindamycin Hydrochloride

Product NDC
0527-1383
11-digit product format
005271383
Labeler code
0527
Product ID
0527-1383_cc80896e-4a77-45d4-8625-9ac72e5fbfd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA065243
Marketing category
ANDA
Marketing start
2005-08-12
Marketing end
0000-00-00
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1383-01EA - Each0527-1383c694163e-d476-47f3-86f9-55cfb819844612012-07-24
0527-1383-02EA - Each0527-1383f305a691-139e-4af6-8c59-7a3a8b1b2ec712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN HYDROCHLORIDEACTIVE INGREDIENTT20OQ1YN1WCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71OCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSNcda84baf-0822-46db-b0eb-e89e7076cb468
284215clindamycin 300 MG Oral CapsuleSCDcda84baf-0822-46db-b0eb-e89e7076cb468
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYcda84baf-0822-46db-b0eb-e89e7076cb468
284215clindamycin HCl 300 MG Oral CapsulePSN6b14e5bc-0340-10da-e053-2991aa0ac6f23
284215clindamycin 300 MG Oral CapsuleSCD6b14e5bc-0340-10da-e053-2991aa0ac6f23
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY6b14e5bc-0340-10da-e053-2991aa0ac6f23
284215clindamycin HCl 300 MG Oral CapsulePSN075dbfb1-47c2-4578-a212-f8e656f0e9f92
284215clindamycin 300 MG Oral CapsuleSCD075dbfb1-47c2-4578-a212-f8e656f0e9f92
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY075dbfb1-47c2-4578-a212-f8e656f0e9f92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1383-0100527138301100 CAPSULE in 1 BOTTLE (0527-1383-01) 100 capsule2005-08-120000-00-00NoNoCurrent
0527-1383-020052713830216 CAPSULE in 1 BOTTLE (0527-1383-02) 16 capsule2005-08-120000-00-00NoNoCurrent