Clindamycin Hydrochloride

Product NDC
61919-057
11-digit product format
619190057
Labeler code
61919
Product ID
61919-057_b67323ba-8b04-9b84-e053-2a95a90a4092
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
ANDA065061
Marketing category
ANDA
Marketing start
2015-01-01
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
No
Listing certified through
2021-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-057-202025-01-30C16284748780-12cef2736-9bca-d83d-e063-dadaa90ab31fCLINDAMYCIN HYDROCHLORIDE 150mg
61919-057-212025-01-30C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-282025-01-30C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-302025-01-30C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-402025-01-30C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-422025-01-30C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-212020-12-14C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-282020-12-14C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-302020-12-14C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-402020-12-14C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-422020-12-14C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-212020-01-31C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-282020-01-31C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-302020-01-31C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-402020-01-31C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride
61919-057-422020-01-31C16284748780-19d75b9d0-abfa-f424-e053-dadaa90a57ceClindamycin Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-057-21Clindamycin Hydrochloride21 in 1 BOTTLECAPSULE216
61919-057-28Clindamycin Hydrochloride28 in 1 BOTTLECAPSULE286
61919-057-30Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE306
61919-057-40Clindamycin Hydrochloride40 in 1 BOTTLECAPSULE406
61919-057-42Clindamycin Hydrochloride42 in 1 BOTTLECAPSULE426
61919-057-20CLINDAMYCIN HYDROCHLORIDE20 in 1 BOTTLECAPSULE202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-057-20EA - Each61919-05702179f2f-8226-4575-b51d-0021c524f3de12019-08-06
61919-057-21EA - Each61919-05790d219b4-365b-4cf5-ba5c-53b7474c57d812016-09-02
61919-057-30EA - Each61919-057e7c3fb42-8282-494e-a2fc-1d7d484e2a8f12015-10-02
61919-057-40EA - Each61919-05781c257a3-bccb-4b3b-b0a3-b52e1e35b75a12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN HYDROCHLORIDEACTIVE INGREDIENTT20OQ1YN1WCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
GELATININACTIVE INGREDIENT2G86QN327LCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
SHELLACINACTIVE INGREDIENT46N107B71OCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
TALCINACTIVE INGREDIENT7SEV7J4R1UCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-057CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]6Legacy NDC, 5 package rows20230401_9b993b19-e471-46ac-8bd3-40968796a30e.zip
61919-057CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2Legacy NDC, 1 package rows20200129_2ebc6f29-d014-4c86-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN9b993b19-e471-46ac-8bd3-40968796a30e6
197518clindamycin 150 MG Oral CapsuleSCD9b993b19-e471-46ac-8bd3-40968796a30e6
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY9b993b19-e471-46ac-8bd3-40968796a30e6
197518clindamycin HCl 150 MG Oral CapsulePSN2ebc6f29-d014-4c86-e054-00144ff8d46c2
197518clindamycin 150 MG Oral CapsuleSCD2ebc6f29-d014-4c86-e054-00144ff8d46c2
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY2ebc6f29-d014-4c86-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-057-206191900572020 CAPSULE in 1 BOTTLE (61919-057-20) 20 capsule2016-03-020000-00-00NoNoCurrent
61919-057-216191900572121 CAPSULE in 1 BOTTLE (61919-057-21) 21 capsule2015-01-010000-00-00NoNoCurrent
61919-057-286191900572828 CAPSULE in 1 BOTTLE (61919-057-28) 28 capsule2015-01-010000-00-00NoNoCurrent
61919-057-306191900573030 CAPSULE in 1 BOTTLE (61919-057-30) 30 capsule2015-01-010000-00-00NoNoCurrent
61919-057-406191900574040 CAPSULE in 1 BOTTLE (61919-057-40) 40 capsule2015-01-010000-00-00NoNoCurrent
61919-057-426191900574242 CAPSULE in 1 BOTTLE (61919-057-42) 42 capsule2015-01-010000-00-00NoNoCurrent