FDA.reportPublic FDA data

Clindamycin hydrochloride

Product NDC
71335-0320
11-digit product format
713350320
Labeler code
71335
Product ID
71335-0320_3a7a1f69-05e7-4517-b448-39cd6d06a143
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065061
Marketing category
ANDA
Marketing start
2001-03-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT20OQ1YN1W
Rxcui284215

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0320-0Clindamycin hydrochloride16 in 1 BOTTLECAPSULE16104
71335-0320-1Clindamycin hydrochloride30 in 1 BOTTLECAPSULE30104
71335-0320-2Clindamycin hydrochloride20 in 1 BOTTLECAPSULE20104
71335-0320-3Clindamycin hydrochloride40 in 1 BOTTLECAPSULE40104
71335-0320-4Clindamycin hydrochloride21 in 1 BOTTLECAPSULE21104
71335-0320-5Clindamycin hydrochloride28 in 1 BOTTLECAPSULE28104
71335-0320-6Clindamycin hydrochloride12 in 1 BOTTLECAPSULE12104
71335-0320-7Clindamycin hydrochloride120 in 1 BOTTLECAPSULE120104
71335-0320-8Clindamycin hydrochloride14 in 1 BOTTLECAPSULE14104
71335-0320-9Clindamycin hydrochloride45 in 1 BOTTLECAPSULE45104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0320-0EA - Each71335-0320dc491fd8-d94e-4236-8457-832dc348782a12018-01-12
71335-0320-1EA - Each71335-0320e178f9ba-524b-42dd-b6bd-597d194bd3d812018-01-12
71335-0320-2EA - Each71335-03206ab78ffa-cca6-40ac-b4e5-0179c993ba1d12018-01-12
71335-0320-3EA - Each71335-03203fdff89e-9506-4856-b211-1366fd91bbba12018-01-12
71335-0320-4EA - Each71335-03206c17981d-6e03-4a3c-ac13-be5fb61b494112018-01-12
71335-0320-5EA - Each71335-0320ea73dcc1-1528-4c87-b5f0-5c4f07af8e7512018-01-12
71335-0320-6EA - Each71335-032049558d6f-6e5b-4a4c-a537-c3a5b6a60a6512018-01-12
71335-0320-7EA - Each71335-0320097e690d-9f5c-49ab-9d1c-88a82ca091ca12018-01-12
71335-0320-8EA - Each71335-0320da7a9124-5612-41e7-a5d6-2740c868081e12018-01-12
71335-0320-9EA - Each71335-0320f1a2b713-682d-42db-baea-b80fa455cf6012018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0320CLINDAMYCIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240913_2b13d66d-4f48-477e-ba32-20e85d0e708d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSN2b13d66d-4f48-477e-ba32-20e85d0e708d104
284215clindamycin 300 MG Oral CapsuleSCD2b13d66d-4f48-477e-ba32-20e85d0e708d104
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY2b13d66d-4f48-477e-ba32-20e85d0e708d104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0320-07133503200016 CAPSULE in 1 BOTTLE (71335-0320-0) 16 capsule2024-09-050000-00-00NoNoCurrent
71335-0320-17133503200130 CAPSULE in 1 BOTTLE (71335-0320-1) 30 capsule2018-05-070000-00-00NoNoCurrent
71335-0320-27133503200220 CAPSULE in 1 BOTTLE (71335-0320-2) 20 capsule2018-06-010000-00-00NoNoCurrent
71335-0320-37133503200340 CAPSULE in 1 BOTTLE (71335-0320-3) 40 capsule2018-06-260000-00-00NoNoCurrent
71335-0320-47133503200421 CAPSULE in 1 BOTTLE (71335-0320-4) 21 capsule2018-05-310000-00-00NoNoCurrent
71335-0320-57133503200528 CAPSULE in 1 BOTTLE (71335-0320-5) 28 capsule2018-10-040000-00-00NoNoCurrent
71335-0320-67133503200612 CAPSULE in 1 BOTTLE (71335-0320-6) 12 capsule2018-09-180000-00-00NoNoCurrent
71335-0320-771335032007120 CAPSULE in 1 BOTTLE (71335-0320-7) 120 capsule2024-09-050000-00-00NoNoCurrent
71335-0320-87133503200814 CAPSULE in 1 BOTTLE (71335-0320-8) 14 capsule2018-07-110000-00-00NoNoCurrent
71335-0320-97133503200945 CAPSULE in 1 BOTTLE (71335-0320-9) 45 capsule2018-12-100000-00-00NoNoCurrent