FDA.reportPublic FDA data

Clindamycin Hydrochloride

Product NDC
68788-8685
11-digit product format
687888685
Labeler code
68788
Product ID
68788-8685_f22b8915-c4dd-4a51-ab2e-2b77a73526da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216957
Marketing category
ANDA
Marketing start
2024-06-01
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
68788-8685-1Clindamycin Hydrochloride14 in 1 BOTTLECAPSULE143
68788-8685-2Clindamycin Hydrochloride20 in 1 BOTTLECAPSULE203
68788-8685-3Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE303
68788-8685-4Clindamycin Hydrochloride40 in 1 BOTTLECAPSULE403
68788-8685-5Clindamycin Hydrochloride56 in 1 BOTTLECAPSULE563
68788-8685-6Clindamycin Hydrochloride60 in 1 BOTTLECAPSULE603
68788-8685-8Clindamycin Hydrochloride21 in 1 BOTTLECAPSULE213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8685-1EA - Each68788-8685c107505a-4769-49a3-b90a-798eba88d9c812024-08-12
68788-8685-2EA - Each68788-8685140fcd31-802d-4de9-8609-9a0d9c6ecdc412024-08-12
68788-8685-3EA - Each68788-868521dec46c-eb8d-4174-aef4-b53ad84a3d8c12024-08-12
68788-8685-4EA - Each68788-86859b3c995e-a7ec-44e3-a4eb-26efa12200d412024-08-12
68788-8685-5EA - Each68788-86853682bb3c-82f3-418a-a7ee-2192a30039da12024-08-12
68788-8685-6EA - Each68788-86851e09428f-0b1e-434d-935f-ade803e200ca12024-08-12
68788-8685-8EA - Each68788-868519071cf1-9bf9-4874-ae1b-ca69524237e512024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8685CLINDAMYCIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 7 package rows20250306_adf8f0fa-f794-4e97-a7b3-16b55d9c9a68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSNadf8f0fa-f794-4e97-a7b3-16b55d9c9a683
284215clindamycin 300 MG Oral CapsuleSCDadf8f0fa-f794-4e97-a7b3-16b55d9c9a683
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYadf8f0fa-f794-4e97-a7b3-16b55d9c9a683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8685-16878886850114 CAPSULE in 1 BOTTLE (68788-8685-1) 14 capsule2024-06-01NoNoHistorical
68788-8685-26878886850220 CAPSULE in 1 BOTTLE (68788-8685-2) 20 capsule2024-06-01NoNoHistorical
68788-8685-36878886850330 CAPSULE in 1 BOTTLE (68788-8685-3) 30 capsule2024-06-01NoNoHistorical
68788-8685-46878886850440 CAPSULE in 1 BOTTLE (68788-8685-4) 40 capsule2024-06-01NoNoHistorical
68788-8685-56878886850556 CAPSULE in 1 BOTTLE (68788-8685-5) 56 capsule2024-06-01NoNoHistorical
68788-8685-66878886850660 CAPSULE in 1 BOTTLE (68788-8685-6) 60 capsule2024-06-01NoNoHistorical
68788-8685-86878886850821 CAPSULE in 1 BOTTLE (68788-8685-8) 21 capsule2024-06-01NoNoHistorical