FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
71335-2432
11-digit product format
713352432
Labeler code
71335
Product ID
71335-2432_c2732cc8-1f62-4226-a3af-34becacd283f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216957
Marketing category
ANDA
Marketing start
2023-03-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin Hydrochloride
Listing expiration
2027-12-31

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
71335-2432-0Clindamycin Hydrochloride16 in 1 BOTTLECAPSULE163
71335-2432-1Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE303
71335-2432-2Clindamycin Hydrochloride20 in 1 BOTTLECAPSULE203
71335-2432-3Clindamycin Hydrochloride40 in 1 BOTTLECAPSULE403
71335-2432-4Clindamycin Hydrochloride21 in 1 BOTTLECAPSULE213
71335-2432-5Clindamycin Hydrochloride28 in 1 BOTTLECAPSULE283
71335-2432-6Clindamycin Hydrochloride12 in 1 BOTTLECAPSULE123
71335-2432-7Clindamycin Hydrochloride120 in 1 BOTTLECAPSULE1203
71335-2432-8Clindamycin Hydrochloride14 in 1 BOTTLECAPSULE143
71335-2432-9Clindamycin Hydrochloride45 in 1 BOTTLECAPSULE453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2432-1EA - Each71335-2432f21f064d-0b18-49c4-b2ee-aaa0763bbe8112025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2432CLINDAMYCIN HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]2Current NDC, 10 package rows20241019_e4d91d51-b92e-4d3e-8379-f9463f450537.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSNe4d91d51-b92e-4d3e-8379-f9463f4505373
284215clindamycin 300 MG Oral CapsuleSCDe4d91d51-b92e-4d3e-8379-f9463f4505373
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYe4d91d51-b92e-4d3e-8379-f9463f4505373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2432-07133524320016 CAPSULE in 1 BOTTLE (71335-2432-0) 16 capsule2024-10-04NoNoHistorical
71335-2432-17133524320130 CAPSULE in 1 BOTTLE (71335-2432-1) 30 capsule2024-07-25NoNoHistorical
71335-2432-27133524320220 CAPSULE in 1 BOTTLE (71335-2432-2) 20 capsule2024-07-24NoNoHistorical
71335-2432-37133524320340 CAPSULE in 1 BOTTLE (71335-2432-3) 40 capsule2024-09-23NoNoHistorical
71335-2432-47133524320421 CAPSULE in 1 BOTTLE (71335-2432-4) 21 capsule2024-10-04NoNoHistorical
71335-2432-57133524320528 CAPSULE in 1 BOTTLE (71335-2432-5) 28 capsule2024-10-04NoNoHistorical
71335-2432-67133524320612 CAPSULE in 1 BOTTLE (71335-2432-6) 12 capsule2024-10-04NoNoHistorical
71335-2432-771335243207120 CAPSULE in 1 BOTTLE (71335-2432-7) 120 capsule2024-10-04NoNoHistorical
71335-2432-87133524320814 CAPSULE in 1 BOTTLE (71335-2432-8) 14 capsule2024-07-03NoNoHistorical
71335-2432-97133524320945 CAPSULE in 1 BOTTLE (71335-2432-9) 45 capsule2024-10-04NoNoHistorical