FDA.reportPublic FDA data

Clindamycin HCL

Product NDC
80425-0145
11-digit product format
804250145
Labeler code
80425
Product ID
80425-0145_2a999573-1034-813a-e063-6294a90a49b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA065442
Marketing category
ANDA
Marketing start
2009-08-26
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 HCL
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
80425-0145-1Clindamycin HCL30 in 1 BOTTLECAPSULE307
80425-0145-2Clindamycin HCL21 in 1 BOTTLECAPSULE217
80425-0145-3Clindamycin HCL28 in 1 BOTTLECAPSULE287

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0145-1EA - Each80425-01459c7783db-74da-42a3-a2ac-cb62f3f1972e12023-03-13
80425-0145-2EA - Each80425-014518b7476f-567b-497c-8f05-2e8653d2e7f412023-06-06
80425-0145-3EA - Each80425-0145bc0293fa-7e41-4b0b-a592-74cf7d1a158d12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0145CLINDAMYCIN HCL CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_c46cac0a-0c36-02fa-e053-2995a90a772b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSNc46cac0a-0c36-02fa-e053-2995a90a772b7
284215clindamycin 300 MG Oral CapsuleSCDc46cac0a-0c36-02fa-e053-2995a90a772b7
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSYc46cac0a-0c36-02fa-e053-2995a90a772b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0145-18042501450130 CAPSULE in 1 BOTTLE (80425-0145-1) 30 capsule2009-08-260000-00-00NoNoCurrent
80425-0145-28042501450221 CAPSULE in 1 BOTTLE (80425-0145-2) 21 capsule2023-03-30NoNoCurrent
80425-0145-38042501450328 CAPSULE in 1 BOTTLE (80425-0145-3) 28 capsule2023-09-12NoNoCurrent