CLINDAMYCIN HYDROCHLORIDE

Product NDC
61919-441
11-digit product format
619190441
Labeler code
61919
Product ID
61919-441_eac5fb0f-0d70-4dbf-e053-2a95a90a818c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLINDAMYCIN HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA065061
Marketing category
ANDA
Marketing start
2014-01-01
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
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
61919-441-20CLINDAMYCIN HYDROCHLORIDE20 in 1 BOTTLECAPSULE209
61919-441-21CLINDAMYCIN HYDROCHLORIDE21 in 1 BOTTLECAPSULE219
61919-441-28CLINDAMYCIN HYDROCHLORIDE28 in 1 BOTTLECAPSULE289
61919-441-30CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE309
61919-441-40CLINDAMYCIN HYDROCHLORIDE40 in 1 BOTTLECAPSULE409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-441-20EA - Each61919-44135ca32be-246f-46f7-aaea-cc062cee624312019-11-12
61919-441-28EA - Each61919-4413edb49cb-304f-450b-8520-c47f7b00c2c112020-04-20
61919-441-30EA - Each61919-4413451c5d0-103b-4364-b64e-9bc9f031192112014-05-02
61919-441-40EA - Each61919-441e01cbc9e-eff2-4748-9fdb-7cca0d91105412014-05-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-441CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]9Legacy NDC, 5 package rows20230422_387e898b-1c91-4ee6-bfac-48f054cda615.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSN387e898b-1c91-4ee6-bfac-48f054cda6159
284215clindamycin 300 MG Oral CapsuleSCD387e898b-1c91-4ee6-bfac-48f054cda6159
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY387e898b-1c91-4ee6-bfac-48f054cda6159

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-441-206191904412020 CAPSULE in 1 BOTTLE (61919-441-20) 20 capsule2014-01-010000-00-00NoNoCurrent
61919-441-216191904412121 CAPSULE in 1 BOTTLE (61919-441-21) 21 capsule2014-01-010000-00-00NoNoCurrent
61919-441-286191904412828 CAPSULE in 1 BOTTLE (61919-441-28) 28 capsule2014-01-010000-00-00NoNoCurrent
61919-441-306191904413030 CAPSULE in 1 BOTTLE (61919-441-30) 30 capsule2022-09-270000-00-00NoNoCurrent
61919-441-406191904414040 BOTTLE in 1 BOTTLE (61919-441-40) > 30 CAPSULE in 1 BOTTLE (61919-441-30) 40 bottle2014-03-250000-00-00NoNoCurrent